Evofem Biosciences, announced that the United States Patent and Trademark Office (USPTO) issued to the Company a Notice of Allowance for patent application 17/028,838, entitled “Method and Pharmaceutical Composition for Treating or Preventing Trichomoniasis and Uses Thereof.” This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

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“This new U.S. patent extends SOLOSEC’s IP protection by a full five years, from 2035 to 2040,” said Saundra Pelletier, Chief Executive Officer of Evofem. “This extension, for the treatment of trichomoniasis, significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand with its single-dose regimen.”

The allowed patent application is directed to treatment of Trichomonas vaginalis infections (trichomoniasis) with SOLOSEC (secnidazole) 2 g oral granules, with broad claims centered on pharmacokinetics and formulation features of Evofem’s single-dose oral antimicrobial agent. Evofem expects the resulting patent will be Orange Book-listable. 

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Trichomoniasis is the most common non-viral sexually transmitted infection in the world. There are an estimated 6.9 million new infections with T. vaginalis in the U.S. each year.1 Undiagnosed infections and lack of compliance with multi-day treatment regimens are critical contributing factors. All sexual partners of people infected with trichomoniasis should be treated with the same dose and at the same time to prevent reinfection. SOLOSEC is designed to be easy to take; one oral dose contains a complete course of treatment.

SOLOSEC is the first and only single-dose oral antibiotic FDA-approved to treat bacterial vaginosis (BV) in females 12 years of age and older as well as trichomoniasis in people 12 years of age and older. Evofem acquired global rights to the product in July 2024 and relaunched SOLOSEC in the U.S. in November 2024 with its women’s health-focused commercial team.

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Source – prnewswire