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TherapeuticsMD Announces Issuance of First Orange Book Listable U.S. Patent for ANNOVERA®
-Newly-issued patent provides U.S. patent protection for ANNOVERA® into 2039- BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":"\n-Newly-issued patent provides U.S. patent protection for ANNOVERA® into 2039-\n\n BOCA RATON, Fla.--(BUSINESS WIRE)--\nTherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative women’s healthcare company, today announced that the United States Patent and Trademark Office (USPTO) has issued a patent that covers the labeled indication 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. TherapeuticsMD has 30 days to submit the formal paperwork to have this patent listed in the U.S. Food and Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book).\n\n\nIn addition to this patent, which provides protection through 2039, ANNOVERA contains segesterone acetate, a “new chemical entity,” which qualifies ANNOVERA for FDA regulatory exclusivity through August 2023 under the Hatch-Waxman Act.\n\n\n\"The issuance of this patent strengthens the intellectual property protection for ANNOVERA, providing Orange Book-listed patent protection through 2039. This is an important step in the ongoing development of the patent portfolio for ANNOVERA,” said TherapeuticsMD Chief Executive Officer, Robert Finizio.\n\n\nAbout ANNOVERA\n\n\nINDICATION\n\n\nANNOVERA is a progestin/estrogen combination hormonal contraceptive indicated for use by females of reproductive potential to prevent pregnancy.\n\n\nLimitation of Use: ANNOVERA has not been adequately studied in females with a body mass index of >29 kg/m2.\n\n\nIMPORTANT SAFETY INFORMATION\n\n\n\n\nWARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS\n\n\n\n\n\nSee full prescribing information for complete boxed warning.\n\n\n\n\n\n\nFemales over 35 years old who smoke should not use ANNOVERA.\n\n\nCigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive use.\n\n\n\n\n\n\nCONTRAINDICATIONS\n\n\nANNOVERA is contraindicated and should not be used in women with a high risk of arterial or venous thrombotic diseases; current or history of breast cancer or other estrogen- or progestin-sensitive cancer; liver tumors, acute hepatitis, or severe (decompensated) cirrhosis; undiagnosed abnormal uterine bleeding; hypersensitivity to any of the comp...