Benzinga | Sep 9, 2020 04:08PM EDT

TherapeuticsMD Reports New Patents Expand US Patent Protection For ANNOVERA

TherapeuticsMD, Inc. (NASDAQ:TXMD), an innovative women's healthcare company, today announced patent updates for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system), the first and only long-lasting, patient-controlled, procedure-free, reversible prescription contraceptive option for women. On September 8, 2020, the United States Patent and Trademark Office (USPTO) issued its second ANNOVERA patent (U.S. Patent No. 10,765,628) that can be listed in the U.S. Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book). In addition, based on recent communications from the USPTO, a third ANNOVERA patent (U.S. Patent No. 10,780,047) is scheduled to be issued on September 22, 2020. These Orange Book eligible patents, which provide patent protection through 2039, cover ANNOVERA and its use for the labeled indication of preventing pregnancy in females of reproductive potential.

"Before the issuance of the first Orange Book listable patent for ANNOVERA, the product was protected by FDA regulatory exclusivity through 2023 as a new chemical entity. These additional patents, which cover different aspects of ANNOVERA, provide independent layers of patent protection," said Robert Finizio, TherapeuticsMD Chief Executive Officer. "As part of our intellectual property strategy, we continue to fortify ANNOVERA's patent portfolio to provide lasting durability for our flagship product. ANNOVERA is a critical component of our drive towards EBITDA breakeven in 2021."