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FDA opens public docket for comments on VOQUEZNA NCE exclusivity challenged by BDR Pharmaceuticals
PHATPhathom Pharmaceuticals, Inc.
The U.S. Food and Drug Administration established a public docket (Docket No. FDA-2026-N-13038) to solicit comment on legal and regulatory questions regarding the New Chemical Entity (NCE) exclusivity for VOQUEZNA tablets. The deadline for comments is November 23, 2026. This action follows litigation brought by BDR Pharmaceuticals against the FDA after it rejected an Abbreviated New Drug Application referencing VOQUEZNA. The FDA had previously granted Phathom’s Citizen Petition, agreeing that VOQUEZNA benefits from 10 years of NCE exclusivity through May 3, 2032. A second filer, Saba Ilac Sanayii Ve Ticaret AS, intends to consolidate its case with BDR’s. The outcome could impact the duration of Phathom's regulatory protection for its flagship product. Phathom Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing treatments for gastrointestinal diseases.