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TherapeuticsMD Announces Issuance of U.S. Patent Covering Natural Combination Hormone Replacement Formulations and Therapies, Including TX 12-001-HR


TherapeuticsMD (NYSE: TXMD), a women's healthcare company ("TherapeuticsMD" or the "Company"), announced today that the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 8,633,178 (the '178 patent; U.S. Application No. 13/684,002), entitled "Natural Combination Hormone Replacement Formulations and Therapies." The '178 patent is expected to expire in the early 2030s and covers the Company's platform technology and TX 12-001-HR, its oral bioidentical 17β-estradiol and progesterone combination drug candidate.

"The issuance of this patent is significant because it covers both our platform technology and our lead product candidate, TX 12-001-HR. It also marks a significant step in building an extensive patent portfolio to cover our novel pipeline of women's healthcare products," said Robert G. Finizio, Chief Executive Officer and Co-founder of TherapeuticsMD.

"The recent convergence of significant events, including the passage of the Drug Quality and Security Act overlapping with this key patent issuance, validates our significant future opportunities in the $3.7 billion hormone therapy market, based on a recent study conducted by inThought™, a Symphony Health Solutions company, that we commissioned."

In December 2013, TherapeuticsMD filed eleven additional U.S. patent applications, seven of which are associated with its platform combination technology. To date, TherapeuticsMD has filed 30 patent applications and intends to file additional patent applications in the first quarter of 2014.

About TX 12-001-HR

TX 12-001-HR is a bioidentical investigational drug designed to treat menopausal symptoms by replacing the 17ß-estradiol and progesterone hormones that women's bodies stop producing as the result of menopause. Enrollment is currently under way in the REPLENISH Trial, a phase 3, investigational research study made up of 1,550 patients to evaluate the safety and efficacy of TX 12-001-HR in reducing the symptoms of menopause. For more information, please visit:

About TherapeuticsMD, Inc.

TherapeuticsMD, Inc. is a women's healthcare company focused on developing and commercializing products targeted exclusively for women. We are developing advanced hormone therapy pharmaceutical products based on novel technologies that enable delivery of bioidentical hormones through a variety of dosage forms and administration routes. We also manufacture and distribute branded and generic prescription prenatal vitamins, as well as over-the-counter vitamins and cosmetics, under our vitaMedMD® and BocaGreenMD® brands. More information is available at the following websites:,,, and

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