Benzinga | Jun 9, 2021 08:33AM EDT

SCYNEXIS Announces FDA Granted BREXAFEMME Five Years Of Exclusivity Under GAIN Act

SCYNEXIS, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the U.S. Food and Drug Administration (FDA) granted BREXAFEMME (ibrexafungerp tablets), five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act. This exclusivity will be added to any other applicable exclusivity periods, such as the five years of new chemical entity (NCE) exclusivity, for a combined ten-year period of regulatory exclusivity. 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, providing 14 years of protection from generic competitors in the U.S.