TherapeuticsMD Inc. (NASDAQ: TXMD) stock surged by 4.83% at last close while the TXMD stock price soars by 12.52% in the pre-market trading. TherapeuticsMD, Inc. is a cutting-edge healthcare firm that specializes in the development and commercialization of unique treatments for women. With a therapeutic emphasis on family planning, reproductive health, and menopausal management, their products are intended to address the particular changes and problems that women face throughout their lives. The company is dedicated to improving women’s health and raising awareness about their healthcare challenges.
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TXMD stock’ Significant Development
TherapeuticsMD reported that the U.S patent litigation which was announced earlier has been settled down for BIJUVA with Amneal Pharmaceuticals, Amneal Pharmaceuticals, LLC, and Amneal Pharmaceuticals of New York.
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The company awarded Amneal a license to advertise Amneal’s generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) in the United States, beginning on May 25, 2032, or sooner under some circumstances which are the same for settlement agreements of this sort, as part of the settlement. The last of TherapeuticsMD’s BIJUVA patents now expire on November 21, 2032, according to the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluation (“Orange Book”).
Rob Finizio, the CEO of the company stated that this settlement of only 180 days off the life of their patents illustrates the power of the patent estate they have created for BIJUVA.
The lawsuit, which is currently on hold in the United States District Court for the District of New Jersey since 2020, stems from Amneal’s submission to the FDA of an Abbreviated New Drug Application wanting authorization for a generic version of BIJUVA before the patent expiration date of November 21, 2032, as listed in the Orange Book. The companies will submit a consent judgement with the United States District Court for the District of New Jersey, prohibiting Amneal from marketing a generic version of BIJUVA (1 mg estradiol and 100 mg progesterone) before the patents-in-suit expire, save as allowed in the settlement and licence.