Evofem says FDA Orange Book lists patent for Solosec treatment

Evofem (EVFM) Biosciences announced that a newly-issued U.S. patent which covers SOLOSEC 2 g oral granules and one of its labeled indications is now listed in the U.S. Food and Drug Administration publication Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. “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.”