TherapeuticsMD, Inc.

United States of America

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IPC Class
A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol 66
A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone 58
A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate 54
A61K 9/00 - Medicinal preparations characterised by special physical form 42
A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters 39
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05 - Pharmaceutical, veterinary and sanitary products 26
41 - Education, entertainment, sporting and cultural services 1
44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services 1
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Registered / In Force 99
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1.

PROGESTERONE FORMULATIONS HAVING A DESIRABLE PK PROFILE

      
Application Number 18517376
Status Pending
Filing Date 2023-11-22
First Publication Date 2024-10-31
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Cacace, Janice
  • Persicaner, Peter H.R.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick
  • Amadio, Julia
  • Bernick, Brian
  • Irani, Neda

Abstract

This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

IPC Classes  ?

  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

2.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number 18485929
Status Pending
Filing Date 2023-10-12
First Publication Date 2024-10-24
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H.R.
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda
  • Amadio, Julia

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

3.

NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES

      
Application Number 18468665
Status Pending
Filing Date 2023-09-15
First Publication Date 2024-04-11
Owner TherapeuticsMD, Inc.. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H.R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/107 - Emulsions
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/70 - Web, sheet or filament bases
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

4.

NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES

      
Application Number 18077212
Status Pending
Filing Date 2022-12-07
First Publication Date 2023-09-28
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Amadio, Julia M.
  • Bernick, Brian A.
  • Mirkin, Sebastian

Abstract

Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/12 - Carboxylic acids; Salts or anhydrides thereof
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61P 5/30 - Oestrogens
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

5.

Natural Combination Hormone Replacement Formulations and Therapies

      
Application Number 18053120
Status Pending
Filing Date 2022-11-07
First Publication Date 2023-07-13
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H.R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/107 - Emulsions
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

6.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number 18046101
Status Pending
Filing Date 2022-10-12
First Publication Date 2023-07-06
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia
  • Persicaner, Peter H.R.

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

7.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number 17515263
Status Pending
Filing Date 2021-10-29
First Publication Date 2022-02-17
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

The invention described herein relates to pharmaceutical compositions that are capable of delivering active pharmaceutical ingredients, such as estrogens, to the vagina and vagina-associated tissues and related methods of making and using such compositions (e.g., in the treatment of disease). Compositions of the invention are capable of being absorbed by the vagina or vagina-associated tissues such that subjects receiving treatment with the compositions may resume ambulatory activity immediately after receiving the treatment, the frequency or amount of discharge associated with the composition is low or negligible, there is little or no systemic absorption associated with the administration of the active pharmaceutical composition, or results in a combination of any or all thereof.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61P 15/02 - Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

8.

Progesterone formulations having a desirable PK profile

      
Application Number 17348140
Grant Number 11865179
Status In Force
Filing Date 2021-06-15
First Publication Date 2022-02-10
Grant Date 2024-01-09
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Cacace, Janice
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick
  • Amadio, Julia
  • Bernick, Brian
  • Irani, Neda

Abstract

This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

IPC Classes  ?

  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

9.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 15781840
Grant Number 11266661
Status In Force
Filing Date 2016-12-07
First Publication Date 2022-01-20
Grant Date 2022-03-08
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/12 - Carboxylic acids; Salts or anhydrides thereof
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

10.

Steroid hormone pharmaceutical formulations

      
Application Number 17169103
Grant Number 11633405
Status In Force
Filing Date 2021-02-05
First Publication Date 2021-08-12
Grant Date 2023-04-25
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Kadajji, Veeran Gowda
  • Bari, Mafruhul
  • Shadiack, Annette
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.

Abstract

This disclosure provides pharmaceutical compositions for delivering estradiol to a subject in need thereof, as well as methods of administering the compositions, and methods of using them.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

11.

Soluble estradiol capsule for vaginal insertion

      
Application Number 16837929
Grant Number 11065197
Status In Force
Filing Date 2020-04-01
First Publication Date 2020-11-12
Grant Date 2021-07-20
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

12.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number 16006721
Status Pending
Filing Date 2018-06-12
First Publication Date 2020-10-29
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Mirkin, Sebastian

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

13.

SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION

      
Application Number 16912665
Status Pending
Filing Date 2020-06-25
First Publication Date 2020-10-15
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H.R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

14.

BIJUVE

      
Application Number 018312977
Status Registered
Filing Date 2020-09-25
Registration Date 2021-02-13
Owner TherapeuticsMD, Inc. (USA)
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Hormone replacement therapy preparations, namely, capsules containing estradiol and progesterone for use in treating the symptoms associated with menopause.

15.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 16833186
Grant Number 11351182
Status In Force
Filing Date 2020-03-27
First Publication Date 2020-09-24
Grant Date 2022-06-07
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda
  • Amadio, Julia

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

16.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 16833188
Grant Number 11241445
Status In Force
Filing Date 2020-03-27
First Publication Date 2020-09-24
Grant Date 2022-02-08
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda
  • Amadio, Julia

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

17.

Soluble estradiol capsule for vaginal insertion

      
Application Number 16833213
Grant Number 10888516
Status In Force
Filing Date 2020-03-27
First Publication Date 2020-09-17
Grant Date 2021-01-12
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

18.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 16834780
Grant Number 11497709
Status In Force
Filing Date 2020-03-30
First Publication Date 2020-09-10
Grant Date 2022-11-15
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia
  • Persicaner, Peter H.R.

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/40 - Gelatin containing
  • A61P 15/02 - Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
  • A61P 15/00 - Drugs for genital or sexual disorders; Contraceptives
  • A61K 9/00 - Medicinal preparations characterised by special physical form

19.

Natural combination hormone replacement formulations and therapies

      
Application Number 16885066
Grant Number 11110099
Status In Force
Filing Date 2020-05-27
First Publication Date 2020-09-10
Grant Date 2021-09-07
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 9/107 - Emulsions
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

20.

Natural combination hormone replacement formulations and therapies

      
Application Number 16885088
Grant Number 11103513
Status In Force
Filing Date 2020-05-27
First Publication Date 2020-09-10
Grant Date 2021-08-31
Owner TherapeuticsMD (USA)
Inventor
  • Bernick, Brian A.
  • Persicaner, Peter H. R.
  • Amadio, Julia M.

Abstract

Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/10 - Dispersions; Emulsions
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

21.

Natural combination hormone replacement formulations and therapies

      
Application Number 16885094
Grant Number 11103516
Status In Force
Filing Date 2020-05-27
First Publication Date 2020-09-10
Grant Date 2021-08-31
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 9/107 - Emulsions
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 9/70 - Web, sheet or filament bases

22.

Progesterone formulations having a desirable pk profile

      
Application Number 16578148
Grant Number 11033626
Status In Force
Filing Date 2019-09-20
First Publication Date 2020-08-27
Grant Date 2021-06-15
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Cacace, Janice
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick
  • Amadio, Julia
  • Bernick, Brian
  • Irani, Neda

Abstract

This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters. In particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

IPC Classes  ?

  • A61K 9/64 - Organic coatings containing proteins or derivatives thereof
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

23.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 16834844
Grant Number 10835487
Status In Force
Filing Date 2020-03-30
First Publication Date 2020-07-23
Grant Date 2020-11-17
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

24.

Soluble estradiol capsule for vaginal insertion

      
Application Number 16837933
Grant Number 11116717
Status In Force
Filing Date 2020-04-01
First Publication Date 2020-07-23
Grant Date 2021-09-14
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

25.

Soluble estradiol capsule for vaginal insertion

      
Application Number 16837937
Grant Number 11123283
Status In Force
Filing Date 2020-04-01
First Publication Date 2020-07-23
Grant Date 2021-09-21
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

26.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 14521002
Grant Number 10806697
Status In Force
Filing Date 2014-10-22
First Publication Date 2020-07-02
Grant Date 2020-10-20
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

27.

BIJUVA

      
Application Number 1537047
Status Registered
Filing Date 2019-08-16
Registration Date 2019-08-16
Owner TherapeuticsMD, Inc. (USA)
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Hormone replacement therapy preparations, namely, capsules containing estradiol and progesterone for use in treating the symptoms associated with menopause.

28.

Soluble estradiol capsule for vaginal insertion

      
Application Number 16773903
Grant Number 11622933
Status In Force
Filing Date 2020-01-27
First Publication Date 2020-06-04
Grant Date 2023-04-11
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

29.

Mold for a medical dosage form

      
Application Number 29699417
Grant Number RE048019
Status In Force
Filing Date 2019-07-25
First Publication Date 2020-06-02
Grant Date 2020-06-02
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Sancilio, Frederick D.
  • Thorsteinsson, Thorsteinn
  • Amadio, Julia M.

30.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number 15975733
Status Pending
Filing Date 2018-05-09
First Publication Date 2020-05-21
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61P 15/02 - Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina

31.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 16677831
Grant Number 11246875
Status In Force
Filing Date 2019-11-08
First Publication Date 2020-03-05
Grant Date 2022-02-15
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Mirkin, Sebastian

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

32.

IMVEXXY

      
Application Number 200667500
Status Registered
Filing Date 2020-01-17
Registration Date 2023-01-25
Owner TherapeuticsMD, Inc. (USA)
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

(1) Pharmaceutical preparations for the treatment of symptoms associated with menopause; pharmaceutical preparations for the treatment of moderate-to-severe dyspareunia due to menopause; hormone replacement therapy preparations for the treatment of symptoms associated with vulvar and vaginal atrophy.

33.

Natural combination hormone replacement formulations and therapies

      
Application Number 16520167
Grant Number 11529360
Status In Force
Filing Date 2019-07-23
First Publication Date 2019-11-14
Grant Date 2022-12-20
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61P 15/00 - Drugs for genital or sexual disorders; Contraceptives
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 9/107 - Emulsions
  • A61K 9/00 - Medicinal preparations characterised by special physical form

34.

Formulations for solubilizing hormones

      
Application Number 16401884
Grant Number 10912783
Status In Force
Filing Date 2019-05-02
First Publication Date 2019-10-24
Grant Date 2021-02-09
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Bernick, Brian A.
  • Amadio, Julia M.

Abstract

Compositions and methods for the solubilization of steroid hormones are disclosed.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/06 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
  • A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/06 - Ointments; Bases therefor
  • A61K 31/015 - Hydrocarbons carbocyclic

35.

Miscellaneous Design

      
Serial Number 88519985
Status Registered
Filing Date 2019-07-17
Registration Date 2019-12-24
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of symptoms associated with menopause

36.

Miscellaneous Design

      
Serial Number 88519977
Status Registered
Filing Date 2019-07-17
Registration Date 2019-12-24
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of symptoms associated with menopause

37.

Miscellaneous Design

      
Serial Number 88517640
Status Registered
Filing Date 2019-07-16
Registration Date 2020-05-05
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of symptoms associated with menopause

38.

Natural combination hormone replacement formulations and therapies

      
Application Number 15999040
Grant Number 11166963
Status In Force
Filing Date 2018-08-16
First Publication Date 2019-05-16
Grant Date 2021-11-09
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61P 15/02 - Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina
  • A61P 5/30 - Oestrogens
  • A61P 15/00 - Drugs for genital or sexual disorders; Contraceptives
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 9/107 - Emulsions
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

39.

BIJUVA

      
Application Number 194770400
Status Registered
Filing Date 2019-02-22
Registration Date 2023-07-25
Owner TherapeuticsMD, Inc. (USA)
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

(1) Pharmaceutical preparations for the treatment of symptoms associated with menopause

40.

Natural combination hormone replacement formulations and therapies

      
Application Number 16104101
Grant Number 11793819
Status In Force
Filing Date 2018-08-16
First Publication Date 2019-02-14
Grant Date 2023-10-24
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.
  • Sancilio, Frederick D.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61P 15/00 - Drugs for genital or sexual disorders; Contraceptives
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 9/107 - Emulsions
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 9/70 - Web, sheet or filament bases

41.

Progesterone formulations

      
Application Number 16037452
Grant Number 10639375
Status In Force
Filing Date 2018-07-17
First Publication Date 2019-01-10
Grant Date 2020-05-05
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
  • A61K 31/566 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol having an oxo group in position 17, e.g. oestrone
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
  • A61K 9/107 - Emulsions

42.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number US2018036790
Publication Number 2018/227172
Status In Force
Filing Date 2018-06-08
Publication Date 2018-12-13
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

The invention described herein relates to pharmaceutical compositions that are capable of delivering active pharmaceutical ingredients, such as estrogens, to the vagina and vagina-associated tissues and related methods of making and using such compositions (e.g., in the treatment of disease). Compositions of the invention are capable of being absorbed by the vagina or vagina-associated tissues such that subjects receiving treatment with the compositions may resume ambulatory activity immediately after receiving the treatment, the frequency or amount of discharge associated with the composition is low or negligible, there is little or no systemic absorption associated with the administration of the active pharmaceutical composition, or results in a combination of any or all thereof.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form

43.

Miscellaneous Design

      
Serial Number 88125885
Status Registered
Filing Date 2018-09-20
Registration Date 2020-05-12
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of vulval vaginal atrophy

44.

Miscellaneous Design

      
Serial Number 88125894
Status Registered
Filing Date 2018-09-20
Registration Date 2020-05-12
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of vulval vaginal atrophy

45.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 15975723
Grant Number 10668082
Status In Force
Filing Date 2018-05-09
First Publication Date 2018-09-13
Grant Date 2020-06-02
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

46.

NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES

      
Application Number US2017064788
Publication Number 2018/136161
Status In Force
Filing Date 2017-12-05
Publication Date 2018-07-26
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Amadio, Julia M.
  • Bernick, Brian A.
  • Mirkin, Sebastian

Abstract

Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

47.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 15893546
Grant Number 10258630
Status In Force
Filing Date 2018-02-09
First Publication Date 2018-06-14
Grant Date 2019-04-16
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

In one aspect, compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises administering an estrogen to a subject having VVA by inserting a dosage form comprising a liquid pharmaceutical composition.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

48.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 15893542
Grant Number 10398708
Status In Force
Filing Date 2018-02-09
First Publication Date 2018-06-14
Grant Date 2019-09-03
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

In one aspect, compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises administering an estrogen to a subject having VVA by inserting a dosage form comprising a liquid pharmaceutical composition.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

49.

I

      
Serial Number 87941900
Status Registered
Filing Date 2018-05-30
Registration Date 2019-03-26
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of vulval vaginal atrophy

50.

I

      
Serial Number 87941908
Status Registered
Filing Date 2018-05-30
Registration Date 2019-06-25
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of vulval vaginal atrophy

51.

Mold for a medical dosage form

      
Application Number 29575454
Grant Number D0811454
Status In Force
Filing Date 2016-08-25
First Publication Date 2018-02-27
Grant Date 2018-02-27
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Sancilio, Frederick D.
  • Thorsteinsson, Thorsteinn

52.

BIJUVA

      
Serial Number 87744084
Status Registered
Filing Date 2018-01-04
Registration Date 2019-06-18
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations, namely, hormone replacement therapy preparations containing estradiol and progesterone for use in treating the symptoms associated with menopause

53.

Pharmaceutical capsule

      
Application Number 29530924
Grant Number D0801518
Status In Force
Filing Date 2015-06-22
First Publication Date 2017-10-31
Grant Date 2017-10-31
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Amadio, Julia M.
  • Thorsteinsson, Thorsteinn

54.

Steroid hormone pharmaceutical composition

      
Application Number 15473733
Grant Number 09931349
Status In Force
Filing Date 2017-03-30
First Publication Date 2017-10-05
Grant Date 2018-04-03
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Shadiack, Annette
  • Persicaner, Peter H. R.
  • Inskeep, Philip B.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Legassie, Jason D.

Abstract

This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

IPC Classes  ?

  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/26 - Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/22 - Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/06 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite

55.

STEROID HORMONE COMPOSITIONS IN MEDIUM CHAIN OILS

      
Application Number US2017024955
Publication Number 2017/173044
Status In Force
Filing Date 2017-03-30
Publication Date 2017-10-05
Owner THERAPEUTICSMD INC. (USA)
Inventor
  • Shadiack, Annette
  • Persicaner, Peter H. R.
  • Inskeep, Philip B.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Legassie, Jason D.

Abstract

This disclosure provides a novel pharmaceutical composition capable of forming micelles upon exposure to the gastric environment. The pharmaceutical composition is suitable for delivering steroid hormones, and progesterone in particular, to a subject in need thereof.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/28 - Steroids, e.g. cholesterol, bile acids or glycyrrhetinic acid

56.

STEROID HORMONE PHARMACEUTICAL COMPOSITION

      
Application Number US2017024994
Publication Number 2017/173071
Status In Force
Filing Date 2017-03-30
Publication Date 2017-10-05
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Inskeep, Philip B.
  • Persicaner, Peter H. R.
  • Shadiack, Annette
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Legassie, Jason D.

Abstract

This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/10 - Dispersions; Emulsions
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
  • A61K 47/06 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite

57.

STEROID HORMONE PHARMACEUTICAL COMPOSITION

      
Application Number US2017025211
Publication Number 2017/173185
Status In Force
Filing Date 2017-03-30
Publication Date 2017-10-05
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Inskeep, Philip B.
  • Persicaner, Peter H.R.
  • Shadiack, Annette
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Legassie, Jason D.

Abstract

This disclosure provides a novel pharmaceutical composition for delivering steroid hormones, such as estradiol and progesterone, to a patient in need thereof.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/107 - Emulsions

58.

STEROID HORMONE COMPOSITIONS IN MEDIUM CHAIN OILS

      
Application Number US2017025220
Publication Number 2017/173191
Status In Force
Filing Date 2017-03-30
Publication Date 2017-10-05
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Shadiack, Annette
  • Persicaner, Peter H.R.
  • Inskeep, Philip B.
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.
  • Legassie, Jason D.

Abstract

This disclosure provides a novel pharmaceutical composition capable of forming micelles upon exposure to the gastric environment. The pharmaceutical composition is suitable for delivering steroid hormones, and the combination of estradiol and progesterone in particular, to a subject in need thereof.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/107 - Emulsions

59.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 15372385
Grant Number 10568891
Status In Force
Filing Date 2016-12-07
First Publication Date 2017-08-03
Grant Date 2020-02-25
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian A.

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

60.

SYMBODA

      
Serial Number 87498387
Status Registered
Filing Date 2017-06-20
Registration Date 2020-11-03
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

A full line of pharmaceutical and dietary preparations produced using proprietary hormone technologies

61.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Document Number 03007636
Status Pending
Filing Date 2016-12-07
Open to Public Date 2017-06-15
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

62.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITIONS AND METHODS

      
Application Number US2016065466
Publication Number 2017/100378
Status In Force
Filing Date 2016-12-07
Publication Date 2017-06-15
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Mirkin, Sebastian
  • Amadio, Julia M.
  • Bernick, Brian

Abstract

Disclosed herein is, among other things, a soft gel vaginal pharmaceutical composition and dosage form containing solubilized estradiol for the treatment of vulvovaginal atrophy (VVA) and female sexual dysfunction (FSD).

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

63.

FOREVHER

      
Serial Number 87398429
Status Registered
Filing Date 2017-04-04
Registration Date 2019-05-07
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 44 - Medical, veterinary, hygienic and cosmetic services; agriculture, horticulture and forestry services

Goods & Services

Providing medical information to patients in the field of relief of perimenopausal and menopausal symptoms with FDA approved treatment options to further patient care in the field of women's health

64.

BIO-IGNITE

      
Serial Number 87340782
Status Registered
Filing Date 2017-02-17
Registration Date 2020-05-26
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 41 - Education, entertainment, sporting and cultural services

Goods & Services

Educational services, namely, providing comprehensive education, namely, providing courses, and educational consultation in the nature of providing courses to patients, all in the field of the relief of perimenopausal and menopausal symptoms with FDA approved treatment options to further patient care in the field of women's health

65.

IMVEXXY

      
Serial Number 87327869
Status Registered
Filing Date 2017-02-07
Registration Date 2018-11-06
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations for the treatment of vulval vaginal atrophy

66.

Natural combination hormone replacement formulations and therapies

      
Application Number 15090493
Grant Number 10675288
Status In Force
Filing Date 2016-04-04
First Publication Date 2016-07-28
Grant Date 2020-06-09
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 9/107 - Emulsions
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/02 - Suppositories; Bougies; Bases for suppositories or bougies

67.

Transdermal cream

      
Application Number 14812179
Grant Number 10098894
Status In Force
Filing Date 2015-07-29
First Publication Date 2016-02-04
Grant Date 2018-10-16
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Amadio, Julia
  • Shadiack, Annette
  • Persicaner, Peter H. R.
  • Winneker, Richard
  • Legassie, Jason
  • Thorsteinsson, Thorsteinn
  • Ghanta, Ajay

Abstract

This disclosure relates to transdermal pharmaceutical compositions containing progesterone in combination with one or more solubilizing agents and penetration enhancers, wherein the pharmaceutical compositions are formulated as creams for topical administration. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, and d-limonene. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, a penetration enhancer (e.g., propylene glycol, a fatty acid ester of propylene glycol, a glycol ether), and optionally d-limonene. In certain embodiments, the pharmaceutical compositions further include estradiol. Methods for treating conditions associated with hormone deficiency in a subject are also described.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 9/06 - Ointments; Bases therefor
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 47/06 - Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite

68.

TRANSDERMAL CREAM

      
Application Number US2015042621
Publication Number 2016/018993
Status In Force
Filing Date 2015-07-29
Publication Date 2016-02-04
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Persicaner, Peter
  • Ghanta, Ajay
  • Amadio, Julia
  • Legassie, Jason
  • Thorsteinsson, Thorsteinn
  • Shadiack, Annette
  • Winneker, Richard

Abstract

This disclosure relates to transdermal pharmaceutical compositions containing progesterone in combination with one or more solubilizing agents and penetration enhancers, wherein the pharmaceutical compositions are formulated as creams for topical administration. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, and d-limonene. In some embodiments, the transdermal pharmaceutical compositions contain progesterone, a medium-chain oil, a penetration enhancer (e.g., propylene glycol, a fatty acid ester of propylene glycol, a glycol ether), and optionally d-limonene. In certain embodiments, the pharmaceutical compositions further include estradiol. Methods for treating conditions associated with hormone deficiency in a subject are also described.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/015 - Hydrocarbons carbocyclic
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/34 - Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
  • A61K 9/06 - Ointments; Bases therefor
  • A61P 17/00 - Drugs for dermatological disorders

69.

Natural combination hormone replacement formulations and therapies

      
Application Number 14719933
Grant Number 10206932
Status In Force
Filing Date 2015-05-22
First Publication Date 2015-12-03
Grant Date 2019-02-19
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Persicaner, Peter H. R.
  • Amadio, Julia M.

Abstract

Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/10 - Dispersions; Emulsions
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

70.

NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES

      
Application Number US2015032213
Publication Number 2015/179782
Status In Force
Filing Date 2015-05-22
Publication Date 2015-11-26
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Persicaner, Peter H.R.
  • Amadio, Julia M.

Abstract

Pharmaceutical compositions for co-administering estradiol and progesterone to a human subject in need thereof are provided. In some embodiments, the pharmaceutical composition comprises solubilized estradiol, suspended progesterone, and a solubilizing agent comprising a medium chain (C6-C12) oil.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61P 5/30 - Oestrogens
  • A61P 5/34 - Gestagens

71.

VITATRUE

      
Serial Number 86775390
Status Registered
Filing Date 2015-10-01
Registration Date 2016-08-23
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Vitamin supplements containing vitamins; vitamin supplements containing minerals; vitamin supplements containing vitamins and minerals; dietary supplements

72.

PROGESTERONE FORMULATIONS

      
Application Number US2015023041
Publication Number 2015/148952
Status In Force
Filing Date 2015-03-27
Publication Date 2015-10-01
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Cacace, Janice
  • Persicaner, Peter
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick
  • Amadio, Julia
  • Bernick, Brian

Abstract

This disclosure provides progesterone formulations, methods of using these formulations, and their related pharmacokinetic parameters, in particular embodiments, the formulations disclosed herein allow for a reduction in the amount of progesterone administered to a patient in need thereof, while still providing the benefits of a larger dosage amount.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/30 - Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates

73.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 14624051
Grant Number 09289382
Status In Force
Filing Date 2015-02-17
First Publication Date 2015-06-18
Grant Date 2016-03-22
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters

74.

Progesterone formulations

      
Application Number 14125547
Grant Number 10052386
Status In Force
Filing Date 2013-06-18
First Publication Date 2015-05-28
Grant Date 2018-08-21
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.

Abstract

Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin
  • A61K 47/10 - Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/573 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
  • A61K 31/566 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol having an oxo group in position 17, e.g. oestrone
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 45/06 - Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
  • A61K 9/107 - Emulsions

75.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS

      
Document Number 02926342
Status Pending
Filing Date 2014-10-22
Open to Public Date 2015-05-21
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Amadio, Julia M.
  • Sanscilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61P 9/10 - Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis
  • A61P 15/12 - Drugs for genital or sexual disorders; Contraceptives for climacteric disorders

76.

VAGINAL INSERTED ESTRADIOL PHARMACEUTICAL COMPOSITONS AND METHODS

      
Application Number US2014061811
Publication Number 2015/073177
Status In Force
Filing Date 2014-10-22
Publication Date 2015-05-21
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Amadio, Julia M.
  • Sanscilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61F 6/06 - Contraceptive devices; Pessaries; Applicators therefor for use by females
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form

77.

Vaginal inserted estradiol pharmaceutical compositions and methods

      
Application Number 14521230
Grant Number 10537581
Status In Force
Filing Date 2014-10-22
First Publication Date 2015-02-12
Grant Date 2020-01-21
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Bernick, Brian A.
  • Thorsteinsson, Thorsteinn
  • Persicaner, Peter H. R.
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda
  • Amadio, Julia

Abstract

According to various embodiments of this disclosure, pharmaceutical compositions comprising solubilized estradiol are provided. In various embodiments, such compositions are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

78.

Natural combination hormone replacement formulations and therapies

      
Application Number 14512046
Grant Number 10806740
Status In Force
Filing Date 2014-10-10
First Publication Date 2015-01-29
Grant Date 2020-10-20
Owner TherapeuticsMD, Inc. (USA)
Inventor
  • Persicaner, Peter H. R.
  • Bernick, Brian A.
  • Amadio, Julia M.

Abstract

Pharmaceutical formulations for co-administering estradiol and progesterone are provided herein. In some embodiments, the formulation comprises solubilized estradiol, suspended progesterone, and a medium chain (C6-C12) oil.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

79.

Natural combination hormone replacement formulations and therapies

      
Application Number 14475864
Grant Number 08993549
Status In Force
Filing Date 2014-09-03
First Publication Date 2014-12-18
Grant Date 2015-03-31
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/70 - Web, sheet or filament bases

80.

Natural combination hormone replacement formulations and therapies

      
Application Number 14475946
Grant Number 09114145
Status In Force
Filing Date 2014-09-03
First Publication Date 2014-12-18
Grant Date 2015-08-25
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/70 - Web, sheet or filament bases

81.

Natural combination hormone replacement formulations and therapies

      
Application Number 14475814
Grant Number 08993548
Status In Force
Filing Date 2014-09-03
First Publication Date 2014-12-18
Grant Date 2015-03-31
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/70 - Web, sheet or filament bases

82.

Natural combination hormone replacement formulations and therapies

      
Application Number 14476040
Grant Number 09114146
Status In Force
Filing Date 2014-09-03
First Publication Date 2014-12-18
Grant Date 2015-08-25
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/70 - Web, sheet or filament bases

83.

Soluble estradiol capsule for vaginal insertion

      
Application Number 14136048
Grant Number 09180091
Status In Force
Filing Date 2013-12-20
First Publication Date 2014-07-31
Grant Date 2015-11-10
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Cacace, Janice Louise
  • Thorsteinsson, Thorsteinn
  • Sancilio, Frederick D.

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/00 - Medicinal preparations characterised by special physical form

84.

THERAPEUTICSMD

      
Application Number 013048871
Status Registered
Filing Date 2014-07-02
Registration Date 2014-11-26
Owner TherapeuticsMD, Inc. (USA)
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Pharmaceutical preparations, namely, hormone replacement therapy preparations; pharmaceutical preparations for the treatment of menopause and post-menopausal symptoms, amenorrhea, and vulvovaginal atrophy.

85.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099562
Grant Number 08987237
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-10
Grant Date 2015-03-24
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/70 - Web, sheet or filament bases
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

86.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099623
Grant Number 09006222
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-10
Grant Date 2015-04-14
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

87.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099598
Grant Number 08987238
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-10
Grant Date 2015-03-24
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

88.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099612
Grant Number 08933059
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-10
Grant Date 2015-01-13
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

89.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099571
Grant Number 08846649
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-03
Grant Date 2014-09-30
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol

90.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099582
Grant Number 09012434
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-04-03
Grant Date 2015-04-21
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 47/44 - Oils, fats or waxes according to two or more groups of ; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin

91.

Natural combination hormone replacement formulations and therapies

      
Application Number 14099545
Grant Number 08846648
Status In Force
Filing Date 2013-12-06
First Publication Date 2014-03-27
Grant Date 2014-09-30
Owner
  • THERAPEUTICSMD, INC. (USA)
  • THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Cacace, Janice Louise
  • Persicaner, Peter H. R.
  • Irani, Neda
  • Amadio, Julia M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/16 - Agglomerates; Granulates; Microbeadlets
  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone

92.

SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION

      
Document Number 02876968
Status In Force
Filing Date 2013-06-18
Open to Public Date 2013-12-27
Grant Date 2022-09-13
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise
  • Sancilio, Frederick D.
  • Irani, Neda

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate
  • A61K 47/14 - Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
  • A61P 15/02 - Drugs for genital or sexual disorders; Contraceptives for disorders of the vagina

93.

SOLUBLE ESTRADIOL CAPSULE FOR VAGINAL INSERTION

      
Application Number US2013046443
Publication Number 2013/192249
Status In Force
Filing Date 2013-06-18
Publication Date 2013-12-27
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H. R.
  • Thorsteinsson, Thorsteinn
  • Cacace, Janice Louise

Abstract

According to various embodiments of this disclosure, pharmaceutical formulations comprising solubilized estradiol are provided. In various embodiments, such formulations are encapsulated in soft capsules which may be vaginally inserted for the treatment of vulvovaginal atrophy.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring

94.

TRANSDERMAL HORMONE REPLACEMENT THERAPIES

      
Application Number US2013046444
Publication Number 2013/192250
Status In Force
Filing Date 2013-06-18
Publication Date 2013-12-27
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H.R.
  • Cacace, Janice Louise
  • Irani, Neda

Abstract

Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.

IPC Classes  ?

  • A61K 31/56 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids

95.

PROGESTERONE FORMULATIONS

      
Application Number US2013046442
Publication Number 2013/192248
Status In Force
Filing Date 2013-06-18
Publication Date 2013-12-27
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Cacace, Janice Louise
  • Persicaner, Peter H.R.

Abstract

Pharmaceutical formulations for oral use in hormone replacement therapy comprising ultra-micronized progesterone are disclosed, wherein the ultra-micronized progesterone is combined with a suitable excipient. The preferred excipients comprise medium chain fatty acid-glycol esters and a nonionic surfactant comprising a polyethylene glycol fatty acid ester. In some embodiments C8 to C18 fatty acid esters of glycerol and polyethylene glycol are the preferred nonionic surfactants.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/48 - Preparations in capsules, e.g. of gelatin, of chocolate

96.

NATURAL COMBINATION HORMONE REPLACEMENT FORMULATIONS AND THERAPIES

      
Application Number US2013046445
Publication Number 2013/192251
Status In Force
Filing Date 2013-06-18
Publication Date 2013-12-27
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian, A.
  • Cacace, Janice, Louise
  • Persicaner, Peter, H.R.
  • Irani, Neda
  • Amadio, Julia, M.

Abstract

Estrogen and progesterone replacement therapies are provided herein. Among others, the following formulations are provided herein: solubilized estradiol without progesterone; micronized progesterone without estradiol; micronized progesterone with partially solubilized progesterone; solubilized estradiol with micronized progesterone; solubilized estradiol with micronized progesterone in combination with partially solubilized progesterone; and solubilized estradiol with solubilized progesterone.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring

97.

FOLMAX

      
Serial Number 86059251
Status Registered
Filing Date 2013-09-09
Registration Date 2014-08-05
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Dietary and pharmaceutical preparations containing folic acid; vitamin or mineral supplements; vitamins for use as a fertility or pregnancy supplement

98.

FEPLUS

      
Serial Number 86059275
Status Registered
Filing Date 2013-09-09
Registration Date 2014-09-16
Owner TherapeuticsMD, Inc. ()
NICE Classes  ? 05 - Pharmaceutical, veterinary and sanitary products

Goods & Services

Vitamin and mineral supplements containing iron

99.

TRANSDERMAL HORMONE REPLACEMENT THERAPIES

      
Document Number 02861346
Status In Force
Filing Date 2013-01-25
Open to Public Date 2013-08-01
Grant Date 2020-04-07
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian A.
  • Amadio, Julia M.
  • Persicaner, Peter H.R.
  • Cacace, Janice Louise
  • Irani, Neda

Abstract

Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.

IPC Classes  ?

  • A61K 31/57 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
  • A61K 9/08 - Solutions
  • A61K 9/70 - Web, sheet or filament bases
  • A61K 31/565 - Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. oestrane, oestradiol
  • A61P 5/30 - Oestrogens

100.

TRANSDERMAL HORMONE REPLACEMENT THERAPIES

      
Application Number US2013023309
Publication Number 2013/112947
Status In Force
Filing Date 2013-01-25
Publication Date 2013-08-01
Owner THERAPEUTICSMD, INC. (USA)
Inventor
  • Bernick, Brian, A.
  • Amadio, Julia, M.
  • Persicaner, Peter H.R.
  • Cacace, Janice, Louise
  • Irani, Neda

Abstract

Hormone replacement therapies are provided comprising solubilized progesterone alone and optionally with an estrogen, cyclic/sequential and continuous-combined dosing, and administered via transdermal HRT delivery systems.

IPC Classes  ?

  • A01N 45/00 - Biocides, pest repellants or attractants, or plant growth regulators containing compounds having three or more carbocyclic rings condensed among themselves, at least one ring not being a six-membered ring
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