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

Phathom disclosed that BDR Pharmaceuticals has sued the FDA and related Federal Defendants in the U.S. District Court for the District of Columbia, challenging the FDA's refusal to accept an ANDA referencing VOQUEZNA and the application of the GAIN Act to Phathom's NCE exclusivity. Phathom maintains that the FDA correctly recognized 10 years of NCE exclusivity for VOQUEZNA tablets through May 3, 2032, in its June 6, 2025 grant of the company's Citizen Petition, and says it intends to take appropriate action to protect its statutory exclusivities.

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