TherapeuticsMD, Inc. (NYSE MKT: 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: www.ReplenishTrial.com. 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: www.therapeuticsmd.com , www.vitamedmd.com , www.vitamedmdrx.com , and www.bocagreenmd.com. Except for the historical information contained herein, the matters set forth in this press release, including statements regarding the Company's belief that this patent is significant because it covers both the Company's platform technology and TX 12-001-HR, its lead product candidate; the Company's belief that the '178 patent marks a significant step in building an extensive patent portfolio to cover the Company's novel pipeline of women's healthcare products; the Company's belief that the recent convergence of significant events, including the passage of the Drug Quality and Security Act overlapping with this key patent issuance, validates the significant future opportunities for the Company in the hormone therapy market; the size of the hormone therapy market; and the Company's plan to file additional patent applications in the first quarter of 2014 are forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including but not limited to: timely and successful completion of clinical studies and the results thereof; challenges and costs inherent in product marketing; the risks and uncertainties associated with economic and market conditions; risks and uncertainties associated with the Company's business and finances in general; and other risks detailed in the Company's filings with the U.S. Securities and Exchange Commission including its annual report on Form 10-K filed on March 12, 2013, reports on Form 10-Q and Form 8-K, and other such filings. These forward-looking statements are based on current information that may change. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and the Company undertakes no obligation to revise or update any forward-looking statement to reflect events or circumstances after the issuance of this press release.
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