Phathom faces lawsuit over VOQUEZNA's 2032 exclusivity
Key points
- Phathom Pharmaceuticals disclosed that BDR Pharmaceuticals has filed a lawsuit challenging the FDA's treatment of regulatory exclusivity for VOQUEZNA (vonoprazan) tablets.
- The dispute concerns the FDA's application of the GAIN Act, which extended VOQUEZNA's New Chemical Entity exclusivity to 10 years, through May 3, 2032.
- Phathom maintains that the FDA correctly granted its December 2024 Citizen Petition and intends to defend its existing regulatory protections.
Phathom Pharmaceuticals (NASDAQ:PHAT) announced that BDR Pharmaceuticals International has filed a lawsuit against the U.S. Food and Drug Administration challenging regulatory exclusivity protections for VOQUEZNA tablets.
The lawsuit, filed in the U.S. District Court for the District of Columbia, principally challenges the FDA's alleged refusal to receive an abbreviated new drug application referencing Phathom's VOQUEZNA approval.
BDR alleges that the FDA improperly applied the Generating Antibiotic Incentives Now Act to recognize an extended period of New Chemical Entity exclusivity for VOQUEZNA.
Phathom said it believes the FDA correctly evaluated the issue when it granted the company's Citizen Petition on June 6, 2025.
The company intends to take appropriate action to protect its statutory exclusivities, which the FDA currently recognizes through May 3, 2032.
Phathom submitted its Citizen Petition on December 11, 2024, seeking to align VOQUEZNA tablets' exclusivity with the protections granted to its earlier vonoprazan-based combination products.
The FDA subsequently updated its Orange Book listing in June 2025 to reflect the 10-year exclusivity period, a decision now at the center of the reported legal dispute.
