The U.S. Food and Drug Administration has opened a public docket for comments on legal and regulatory questions surrounding VOQUEZNA exclusivity, Phathom Pharmaceuticals said on October 26, 2026. The questions arose from litigation brought after the agency rejected a generic drug application referencing the tablets.

Key Takeaways

  • The FDA previously recognized 10 years of exclusivity for VOQUEZNA through May 3, 2032.
  • BDR Pharmaceuticals challenged the FDA after its abbreviated new drug application was rejected.
  • Public comments on the docket are due November 23, 2026.

What is at stake for VOQUEZNA exclusivity

On June 6, 2025, the FDA granted Phathom’s citizen petition and agreed that VOQUEZNA tablets benefit from 10 years of new chemical entity exclusivity through May 3, 2032. BDR Pharmaceuticals, International Pvt. Ltd. subsequently brought litigation challenging that decision after the FDA rejected its abbreviated new drug application.

Phathom said a successful challenge could shorten the exclusivity period and allow the FDA to receive and potentially approve applications referencing VOQUEZNA tablets earlier than currently anticipated. The company also cautioned that the agency could reconsider, modify or reverse its prior decision. No change to the decision was announced in the update.

Phathom plans comments and seeks to intervene

The FDA docket, numbered FDA-2026-N-13038, seeks comments on questions raised by BDR in the litigation. Phathom CEO Steve Basta said the company believes the FDA reached the right decision and will make its case in comments and any appropriate court proceeding.

Phathom has moved to intervene in BDR’s lawsuit. A second purported applicant, Saba Ilac Sanayii Ve Ticaret AS, has notified the court that it has a related case pending and intends to seek consolidation with BDR’s case.

Phathom markets VOQUEZNA tablets in the United States for certain gastrointestinal conditions. The company said the litigation’s timing and outcome remain uncertain.

Next milestone

The next confirmed milestone is the November 23, 2026 deadline for public comments on the FDA docket.

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