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TherapeuticsMD Settles U.S. Patent Litigation with Amneal for BIJUVA® (Estradiol and Progesterone) — Allowing for a May 25, 2032 Generic Entry Date
BOCA RATON, Fla.--(BUSINESS WIRE)-- TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced the settlement of
About this update from Therapeuticsmd, Inc.
[{"type":"text","content":" BOCA RATON, Fla.--(BUSINESS WIRE)--\nTherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced the settlement of the previously disclosed U.S. patent litigation for BIJUVA® with Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals, LLC, and Amneal Pharmaceuticals of New York LLC (collectively “Amneal”).\n\nAs part of the settlement, TherapeuticsMD granted to Amneal a license to commercialize Amneal’s generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) in the United States, commencing on May 25, 2032, or earlier under certain circumstances customary for settlement agreements of this nature. The last of TherapeuticsMD’s BIJUVA patents listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluation (“Orange Book”) currently expire on November 21, 2032. According to Rob Finizio, Chief Executive Officer for TherapeuticsMD, “This settlement of only 180 days off of the life of our patents reflects the strength of the patent estate we have built for BIJUVA.”\n\nThe litigation, which has been pending in the U.S. District Court for the District of New Jersey since 2020, resulted from the submission by Amneal of an Abbreviated New Drug Application to the U.S. Food and Drug Administration seeking approval to market a generic version of BIJUVA before the November 21, 2032 patent expiration date listed in the Orange Book. As part of the settlement, the parties will file a consent judgment with the U.S. District Court for the District of New Jersey that enjoins Amneal from marketing a generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) before the expiration of the patents-in-suit, except as provided for in the settlement and license.\n\nAbout TherapeuticsMD, Inc.\n\nTherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit therapeuticsmd.com or follow us on Twit...