FDA Opens Docket on VOQUEZNA Exclusivity Challenge

The U.S. Food and Drug Administration has established a public docket to solicit comments on regulatory questions regarding the New Chemical Entity exclusivity of VOQUEZNA (vonoprazan) tablets. The agency opened Docket No. FDA-2026-N-13038 following a lawsuit filed by BDR Pharmaceuticals, Intl. Pvt. Ltd., which challenges the FDA's rejection of an abbreviated new drug application referencing the drug.

Phathom Pharmaceuticals, Inc. filed the report with the U.S. Securities and Exchange Commission on October 26, 2026. The company stated that the FDA is reviewing legal and regulatory issues raised in the litigation, which disputes the FDA's June 6, 2025 decision granting Phathom's Citizen Petition. That earlier decision confirmed that VOQUEZNA benefits from 10 years of New Chemical Entity exclusivity through May 3, 2032.

Comments for the public docket are due by November 23, 2026. Phathom, based in Florham Park, New Jersey, maintains that the FDA correctly evaluated the GAIN Act extension of the exclusivity period. The company plans to submit comments to the FDA and participate in any appropriate court proceedings to protect its statutory exclusivities.

A second entity, Saba Ilac Sanayii Ve Ticaret AS, has filed a notice in the BDR litigation. Saba claims to have a pending related case and intends to move to consolidate its proceedings with BDR's suit. Phathom noted that if BDR or Saba succeeds in their challenges, the period of regulatory exclusivity could be reduced. This outcome would permit the FDA to receive and potentially approve competing ANDAs earlier than currently anticipated.

The filing includes forward-looking statements regarding the potential timing and outcome of the litigation and the FDA docket. Phathom warns that adverse developments could impact its stock price, VOQUEZNA sales, and financial condition. The company also notes risks related to maintaining intellectual property protection and defending its Orange Book-listed patents against third-party challenges.

Anne Marie Cook, Chief Legal Officer for Phathom Pharmaceuticals, Inc., signed the report on behalf of the registrant. The company's common stock trades on The Nasdaq Global Select Market under the symbol PHAT.