Phathom Pharmaceuticals announced that BDR Pharmaceuticals has filed a lawsuit against the U.S. Food and Drug Administration (FDA) challenging the market exclusivity period for Phathom's drug, VOQUEZNA. The suit seeks to allow for the earlier filing of an abbreviated new drug application (ANDA) for a generic version of VOQUEZNA, potentially accelerating generic competition.

Key Details

  • Challenged Exclusivity: BDR alleges the FDA improperly applied the GAIN Act to extend Phathom's New Chemical Entity (NCE) exclusivity for VOQUEZNA.
  • Exclusivity Period: Phathom states the FDA correctly granted 10 years of NCE exclusivity for VOQUEZNA tablets, which is expected to last through May 3, 2032.
  • Company Position: Phathom believes the FDA's decision was correct and intends to take appropriate action to protect its statutory exclusivity for the drug.