Phathom Pharmaceuticals Faces Legal Challenge Over VOQUEZNA Exclusivity

05:39 AM EDT, 10/23/2026 (MT Newswires) -- Phathom Pharmaceuticals (PHAT) said Friday that BDR Pharmaceuticals International has sued the US Food and Drug Administration, or FDA, challenging its alleged refusal to accept a generic drug application referencing Phathom's VOQUEZNA. BDR alleges the FDA improperly applied the GAIN Act to extend the drug's new chemical entity exclusivity, it said. Phathom said the FDA correctly granted its citizen petition in June 2025, recognizing exclusivity for VOQUEZNA tablets through May 3, 2032. The company said it is evaluating the lawsuit and intends to take appropriate action to protect its exclusivity rights. Phathom Pharmaceuticals was down 2.9% in Friday premarket trading.