Phathom Pharmaceuticals Provides Update on Litigation Filed by BDR Pharmaceuticals against FDA

FLORHAM PARK, N.J., Oct. 23, 2026 (GLOBE NEWSWIRE) -- Phathom Pharmaceuticals, Inc. (Nasdaq: PHAT), a biopharmaceutical company focused on commercializing and developing novel treatments for gastrointestinal (GI) diseases, announced today that BDR Pharmaceuticals International Pvt. Ltd. (BDR) has filed suit against the U.S. Food and Drug Administration (FDA) and related Federal Defendants in the United States District Court for the District of Columbia, principally challenging FDA’s alleged refusal to receive an abbreviated new drug application (ANDA) referencing Phathom’s new drug application (NDA) for VOQUEZNA®. In the suit, BDR alleges that FDA has improperly applied the GAIN Act to extend Phathom’s New Chemical Entity (NCE) exclusivity for VOQUEZNA (vonoprazan fumarate) tablets. Phathom is evaluating the BDR filings, but believes that FDA carefully and correctly evaluated this issue in its June 6, 2025 grant of Phathom’s December 11, 2024 Citizen Petition, in which FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032. Phathom intends to take appropriate action to protect its statutory exclusivities.