- The FDA has granted five years of exclusivity extension under the Generating Antibiotic Incentives Now (GAIN) Act to Scynexis Inc’s (NASDAQ: SCYX) recently approved Brexafemme (ibrexafungerp tablets) for vaginal yeast infections or vulvovaginal candidiasis.
- This exclusivity 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 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.
- The company will share additional commercialization plans on June 29.
- Price Action: SCYX shares are up 0.60% at $8.38 during the market session on the last check Wednesday.
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