Business
FDA Orange Book Lists New U.S. Patent for SOLOSEC, Evofem Biosciences' "One and Done" Oral Treatment for Bacterial Vaginosis and Trichomoniasis
Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its labeled indications is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.
About this update from Evofem Biosciences, Inc.
[{"type":"text","content":"-- Evofem now holds eleven Orange Book - listed patents covering SOLOSEC into late 2041 --","length":90,"tagName":"p","attribs":{}},{"type":"text","content":"SAN DIEGO, Aug. 19, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its labeled indications is now listed in the U.S. Food and Drug Administration (FDA) publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book.","length":424,"tagName":"p"},{"type":"image","alt":"Women's health innovator Evofem Biosciences (OTCQB: EVFM) (PRNewsfoto/Evofem Biosciences, Inc.)","displaySize":"","headline":null,"caption":"Women's health innovator Evofem Biosciences (OTCQB: EVFM) (PRNewsfoto/Evofem Biosciences, Inc.)","className":"","disableSlideshowImg":false,"size":{"original":{"width":400,"height":209,"url":"https://media.zenfs.com/en/prnewswire.com/b0b393f2cbffee7b6c52a7dea7c44bd2"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/s3aOPVcdo91_a65mo20iIg--/YXBwaWQ9aGlnaGxhbmRlcjt3PTcwNTtoPTM2ODtjZj13ZWJw/https://media.zenfs.com/en/prnewswire.com/b0b393f2cbffee7b6c52a7dea7c44bd2","width":400,"height":209}},"href":"https://mma.prnewswire.com/media/780907/Evofem_Biosciences_Logo.html","hrefExternal":true,"rel":"nofollow"},{"type":"text","content":""The Orange Book listing of this patent covering SOLOSEC's method, pharmaceutical composition, and use in trichomoniasis is an important step in further strengthening our patent portfolio," said Evofem Biosciences CEO Saundra Pelletier. "The patent itself extends SOLOSEC's intellectual property and market exclusivity into December 2041, which significantly benefits prescribers, patients, and our investors with a longer opportunity to build the SOLOSEC brand – the first and only single-dose oral treatment FDA-approved to treat BV as well as trichomoniasis – in the U.S."","length":618,"tagName":"p"},{"type":"text","content":"The newly listed U.S. Patent No. 12,280,037 (the '037 patent) covers "method and pharmaceutical composition for treating or preventing trichomoniasis and uses thereof". The '037 patent was issued by the U.S. Patent and Trademark Office (USPTO) on April ...