BDR Lawsuit Tests VOQUEZNA Exclusivity Through 2032 After Alleged FDA Refusal of Generic Application
Key Facts
BDR Pharmaceuticals sued the U.S. Food and Drug Administration and related federal entities in the U.S. District Court for the District of Columbia, according to an announcement by Phathom Pharmaceuticals in a statement issued on October 23, 2026. The lawsuit concerns what Phathom describes as the agency’s alleged refusal to receive an abbreviated generic drug application that references the company’s original application for VOQUEZNA. BDR says the FDA incorrectly applied the GAIN Act, resulting in an extension of the drug’s new chemical entity exclusivity. The court has not ruled on the dispute, so what BDR calls a refusal to receive the application remains an allegation in the lawsuit as described by Phathom. The challenge puts the interpretation of exclusivity rules before the court as Phathom relies on a prior agency decision concerning VOQUEZNA.
The FDA granted Phathom’s petition on June 6, 2025, determining that VOQUEZNA benefits from NCE*GAIN exclusivity through May 3, 2032, according to the agency letter attached to the company’s filing with the Securities and Exchange Commission. In its response, the agency said it agreed that VOQUEZNA tablets benefit from the exclusivity it had granted to the VOQUEZNA combination products. It based its interpretation of the scope of exclusivity on the active ingredient, explaining that VOQUEZNA itself had not received QIDP designation, but that the combination products share the active ingredient vonoprazan. The agency said applying the exclusivity to the tablets was consistent with the text of the law and its umbrella policy. This background matters to the case because BDR challenges the application of the GAIN Act that led to the agency’s decision, while Phathom describes the exclusivity as an existing legal right.
The agency’s approvals for VOQUEZNA products came in stages: it approved VOQUEZNA Triple Pak and Dual Pak on May 3, 2022, followed by VOQUEZNA tablets on November 1, 2023. According to the agency letter, the active ingredient vonoprazan had received its first approval on the earlier date, before the tablets were approved on the later date. This sequence explains the basis for the agency’s position that exclusivity extends from the combination products to tablets using the same active ingredient. It also shows that the dispute is not limited to a single generic drug application, but concerns how drug exclusivity applies to products that share an active ingredient. The lawsuit leaves it to the court to consider BDR’s challenge to how the agency applied the law in this case.
VOQUEZNA is a growing source of revenue for Phathom: its product revenue reached $175.1 million in 2025, compared with $55.3 million in 2024, according to the company’s annual report. The difference between the two years shows the products’ increasing contribution to the company’s business. Phathom also reported that more than 1.1 million prescriptions for VOQUEZNA and its two combination products had been filled since launch through February 13, 2026. The company said commercial coverage made the drug available to more than 120 million people, or more than 80% of commercially insured people in the United States, according to data as of the same date. These figures put the exclusivity dispute in the context of a product with broad commercial reach and revenue that increased between the two years. But the lawsuit has not determined whether BDR’s application will affect the duration of exclusivity or the course of competition.
In the market, Phathom shares, which trade under the ticker PHAT, closed at $7.01 on October 22, 2026, according to EL7 data. The figure is for the close of the session before the company’s statement about the lawsuit and does not include verified data on the stock’s intraday low or high. Neither the statement nor the available closing data linked the share-price move to the lawsuit, so the close remains a daily indicator separate from the outcome of the litigation. In another development involving the drug, the company said its phase 2 study of treatment for eosinophilic esophagitis had enrolled 95 patients at 41 U.S. sites through June 23, 2026. Phathom expects to announce top-line results in the fourth quarter of 2026, a set date for a clinical update that comes alongside continued monitoring of the legal dispute.
Phathom said it is evaluating BDR’s filings and intends to take appropriate action to protect the drug’s legal exclusivities, without specifying steps or a timeline in its statement. The case before the U.S. District Court for the District of Columbia remains the next focus in the legal dispute, while the available evidence does not include a date for a hearing or court decision. At the company level, the phase 2 study’s top-line results are due in the fourth quarter of 2026, Phathom said in its disclosure about the study. The company also plans to announce its third-quarter results update on October 29, according to the follow-up angle in the evidence. Attention is therefore turning to the company’s response to the lawsuit and its scheduled financial update, with the outcome of neither yet known.