SCYX - Scynexis' Brexafemme qualifies for 10 years of exclusivity for vaginal yeast infections
Scynexis (SCYX) announces that the FDA has granted Brexafemme (ibrexafungerp tablets), five years of exclusivity extension under the Generating Antibiotic Incentives Now ((GAIN)) Act.This grant will be added to any other applicable exclusivity periods, such as the five years of new chemical entity exclusivity, for a combined ten-year period of regulatory exclusivity.Brexafemme is indicated for the treatment of females with vulvovaginal candidiasis ((VVC)), commonly known as a vaginal yeast infection due to Candida.Brexafemme is also protected by multiple patents, including a composition-of-matter patent covering the ibrexafungerp molecule. With patent term extension, this patent is expected to expire in 2035.The company has scheduled commercial launch update call for Tuesday, June 29th @ 12pm ET.Recently, the Brexafemme was approved by U.S. FDA for vaginal yeast infections treatment.
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Scynexis' Brexafemme qualifies for 10 years of exclusivity for vaginal yeast infections