Phathom Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has opened a public docket to review the New Chemical Entity (NCE) exclusivity for its drug, VOQUEZNA. This action was prompted by litigation from a generic drug manufacturer, BDR Pharmaceuticals, which is challenging the FDA's decision to grant VOQUEZNA exclusivity through May 2032. The outcome of this review could potentially allow for earlier generic competition.
Key Details
- FDA Action: The FDA has established a public docket (No. FDA-2026-N-13038) to solicit comments on the exclusivity status of VOQUEZNA, with a comment deadline of November 23, 2026.
- Legal Challenge: The review stems from a lawsuit by BDR Pharmaceuticals, an abbreviated new drug application (ANDA) filer, which is challenging the FDA's June 2025 decision granting VOQUEZNA a 10-year NCE exclusivity period.
- Exclusivity at Risk: The contested exclusivity period is currently set to protect VOQUEZNA from generic competition until May 3, 2032. A second generic filer has also joined the litigation, increasing the challenge to the drug's market protection.