BDR Sues FDA Over Phathom's Voquezna Exclusivity, Which Runs Through May 2032
The generic drugmaker says the agency wrongly stretched protection for the heartburn drug; Phathom says the FDA got it right.
BDR Pharmaceuticals International has sued the FDA in federal court in Washington, challenging the agency's refusal to receive its generic application for Phathom Pharmaceuticals' heartburn drug Voquezna, Phathom said Friday. At stake is exclusivity the FDA recognized through May 3, 2032.
The lawsuit's target
BDR filed in the U.S. District Court for the District of Columbia. The suit mainly challenges the FDA's alleged refusal to receive an abbreviated application, the shortcut route generic makers use, that references Phathom's Voquezna application.
BDR alleges the agency improperly applied the GAIN Act to extend new-chemical-entity exclusivity for Voquezna (vonoprazan fumarate) tablets, according to Phathom's filing.
Phathom's defense
Phathom says the FDA examined the question carefully and correctly when it granted the company's December 11, 2024 citizen petition on June 6, 2025. In that decision, the agency recognized 10 years of exclusivity for Voquezna tablets, through May 3, 2032.
The company said it is evaluating BDR's filings and intends to take appropriate action to protect its statutory exclusivities.
Why the exclusivity matters
Phathom is a commercial-stage drugmaker selling gastrointestinal treatments. Its three approved products, Voquezna tablets and the Voquezna Dual Pak and Triple Pak, contain vonoprazan, an acid blocker, and are approved for reflux disease and Helicobacter pylori infection. All of its revenue comes from U.S. sales of these products, and most of its 2025 revenue came from Voquezna, according to its annual report.
Phathom warned that if BDR wins, the exclusivity period would shrink and the FDA could receive and potentially approve generic applications referencing Voquezna tablets earlier than expected. It also cautioned that the litigation, including any appeals, may be lengthy, costly and distracting to management, and that developments could hurt its stock price and Voquezna sales.
Phathom has said it will act to defend the exclusivity; what that action is, and any FDA ruling on BDR's application, would be the next developments.
Sources
- 8-K Filing — Phathom Pharmaceuticals, Inc. (PHAT) — SEC EDGAR
- Phathom Pharmaceuticals Provides Update on Litigation Filed — globenewswire.com
