BDR Sues FDA Over Phathom VOQUEZNA Exclusivity Extension

Phathom Pharmaceuticals, Inc. disclosed on October 23, 2026, that BDR Pharmaceuticals International Pvt. Ltd. has filed a lawsuit against the U.S. Food and Drug Administration (FDA) in the United States District Court for the District of Columbia. The suit challenges the FDA's decision to reject a generic drug application that cited Phathom's approval for VOQUEZNA. BDR argues that the FDA wrongly used the GAIN Act to lengthen Phathom's New Chemical Entity (NCE) exclusivity for vonoprazan fumarate tablets.

Phathom stated in its Form 8-K that it is currently evaluating the filings by BDR. The company maintains that the FDA carefully and correctly evaluated the issue during its June 6, 2025, grant of Phathom's December 11, 2024, Citizen Petition. In that decision, the FDA recognized 10 years of NCE exclusivity for VOQUEZNA tablets, extending the protection period through May 3, 2032. Phathom intends to take appropriate action to protect its statutory exclusivities against the legal challenge.

The filing identifies several risks associated with the ongoing litigation. If BDR succeeds in its challenge, the period of regulatory exclusivity for VOQUEZNA could be reduced. Such an outcome would permit the FDA to receive and potentially approve ANDAs referencing VOQUEZNA tablets earlier than currently anticipated by Phathom. The company noted that the litigation, including any potential appeals, may be lengthy, costly, and distracting to management, with uncertain timing and outcomes.

Phathom warned that developments in the case or public perception of them could negatively impact its stock price, VOQUEZNA sales, and overall business financial condition. The company also cited risks related to maintaining intellectual property protection, including patent term extensions and non-patent regulatory exclusivity for the expected durations. Failure to defend its Orange Book-listed patents against third-party challenges could result in competition entering the market earlier than expected if regulatory or patent protection is lost as a result of an adverse outcome in the BDR litigation.

The report includes forward-looking statements regarding Phathom's belief in the correctness of the FDA's evaluation and its intent to protect its exclusivities. These statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially from those expressed or implied. Phathom undertakes no obligation to update these statements under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The report was signed by Anne Marie Cook, Chief Legal Officer of Phathom Pharmaceuticals.