Abstract: Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Type:
Grant
Filed:
July 17, 2018
Date of Patent:
May 5, 2020
Assignee:
TherapeuticsMD, Inc.
Inventors:
Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Janice Louise Cacace, Thorsteinn Thorsteinsson, Frederick D. Sancilio, Neda Irani
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).
Type:
Application
Filed:
November 8, 2019
Publication date:
March 5, 2020
Applicant:
TherapeuticsMD, Inc.
Inventors:
Brian A. BERNICK, Julia M. AMADIO, Sebastian MIRKIN
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).
Type:
Grant
Filed:
December 7, 2016
Date of Patent:
February 25, 2020
Assignee:
TherapeuticsMD, Inc.
Inventors:
Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick
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.
Type:
Grant
Filed:
October 22, 2014
Date of Patent:
January 21, 2020
Assignee:
TherapeuticsMD, Inc.
Inventors:
Brian A. Bernick, Thorsteinn Thorsteinsson, Peter H. R. Persicaner, Janice Louise Cacace, Frederick D. Sancilio, Neda Irani, Julia Amadio
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.
Type:
Application
Filed:
February 12, 2019
Publication date:
December 19, 2019
Applicant:
TherapeuticsMD, Inc.
Inventors:
Julia AMADIO, Brian Bernick, Peter H.R. Persicaner
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.
Type:
Grant
Filed:
March 9, 2017
Date of Patent:
November 12, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Janice Cacace, Peter H. R. Persicaner, Thorsteinn Thorsteinsson, Frederick Sancilio, Julia Amadio, Brian Bernick
Abstract: In one aspect, pharmaceutical compositions and methods for the treatment of vulvovaginal atrophy (VVA) are provided. In one embodiment, the method comprises digitally inserting into the lower third of the vagina of a subject having VVA a soft gelatin capsule containing a liquid pharmaceutical composition.
Type:
Grant
Filed:
February 9, 2018
Date of Patent:
November 12, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Brian A. Bernick, Peter H. R. Persicaner, Janice Louise Cacace, Neda Irani, Julia M. Amadio
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.
Type:
Grant
Filed:
February 9, 2018
Date of Patent:
September 3, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick
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.
Type:
Grant
Filed:
March 30, 2017
Date of Patent:
May 14, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Annette Shadiack, Peter H. R. Persicaner, Philip B. Inskeep, Thorsteinn Thorsteinsson, Frederick D. Sancilio, Jason D. Legassie
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.
Type:
Grant
Filed:
February 9, 2018
Date of Patent:
April 16, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Sebastian Mirkin, Julia M. Amadio, Brian A. Bernick
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.
Type:
Grant
Filed:
May 22, 2015
Date of Patent:
February 19, 2019
Assignee:
TherapeuticsMD, Inc.
Inventors:
Brian A. Bernick, Peter H. R. Persicaner, Julia M. Amadio
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.
Type:
Application
Filed:
August 16, 2018
Publication date:
February 14, 2019
Applicant:
TherapeuticsMD, Inc.
Inventors:
BRIAN A. BERNICK, JANICE LOUISE CACACE, PETER H.R. PERSICANER, NEDA IRANI, JULIA M. AMADIO
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.
Type:
Grant
Filed:
July 29, 2015
Date of Patent:
October 16, 2018
Assignee:
TherapeuticsMD, Inc.
Inventors:
Julia Amadio, Annette Shadiack, Peter H. R. Persicaner, Richard Winneker, Jason Legassie, Thorsteinn Thorsteinsson, Ajay Ghanta
Abstract: Various pharmaceutical formulations are disclosed herein. For example, a pharmaceutical formulation is disclosed comprising ultra-micronized progesterone.
Type:
Grant
Filed:
June 18, 2013
Date of Patent:
August 21, 2018
Assignee:
TherapeuticsMD, Inc.
Inventors:
Brian A. Bernick, Julia M. Amadio, Peter H. R. Persicaner, Janice Louise Cacace, Thorsteinn Thorsteinsson, Frederick D. Sancilio
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.
Type:
Application
Filed:
August 2, 2017
Publication date:
March 1, 2018
Applicant:
TherapeuticsMD, Inc.
Inventors:
Julia AMADIO, Brian BERNICK, Peter H.R. PERSICANER
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.
Type:
Application
Filed:
March 9, 2017
Publication date:
November 30, 2017
Applicant:
TherapeuticsMD, Inc.
Inventors:
Janice Cacace, Peter H.R. Persicaner, Thorsteinn Thorsteinsson, Frederick Sancilio, Julia Amadio, Brian Bernick