Phathom faces FDA review of VOQUEZNA 2032 exclusivity

• Phathom Pharmaceuticals announced that the FDA established public docket FDA-2026-N-13038 to seek comments on legal and regulatory questions concerning VOQUEZNA's exclusivity.
• The review follows litigation by BDR Pharmaceuticals challenging the FDA's recognition of 10 years of New Chemical Entity exclusivity for VOQUEZNA through May 3, 2032.
• Phathom plans to defend its exclusivity rights through public comments and litigation, with submissions to the FDA docket due November 23, 2026.

Phathom Pharmaceuticals (NASDAQ:PHAT) announced that the U.S. Food and Drug Administration established a public docket seeking comments on regulatory questions involving VOQUEZNA's exclusivity protections through May 3, 2032.

The FDA docket, numbered FDA-2026-N-13038, follows litigation brought by BDR Pharmaceuticals International after the agency rejected its abbreviated new drug application referencing VOQUEZNA tablets.

“FDA carefully reviewed the NCE exclusivity period applicable to VOQUEZNA through a full public process, and we believe reached the right decision,” said Phathom President and Chief Executive Officer Steve Basta.

The dispute centers on the FDA's June 6, 2025 decision granting Phathom's Citizen Petition and recognizing a 10-year New Chemical Entity exclusivity period under the GAIN Act.

Phathom said it intends to submit comments by the November 23, 2026 deadline and has moved to intervene in BDR's lawsuit to defend its statutory exclusivity protections.

Another prospective generic applicant, Saba Ilac Sanayii Ve Ticaret AS, has notified the court of a related pending case and its intention to seek consolidation with BDR's litigation.

VOQUEZNA contains vonoprazan, a potassium-competitive acid blocker marketed in the United States for certain acid-related gastrointestinal conditions, while the ongoing dispute could affect the timing of future generic competition.