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# BDR Pharma Sues FDA Over Generic Voquezna Exclusivity
- URL: https://www.fdaweb.com/bdr-pharma-sues-fda-over-generic-voquezna-exclusivity/
- Published: 2026-10-22T16:11:39.000Z
- Updated: 2026-10-22T16:11:39.000Z
- Author: David McFarland
- Tags: Drugs

BDR Pharmaceuticals International has filed a lawsuit against FDA, alleging the agency unlawfully extended market exclusivity for Phathom Pharmaceuticals’ acid-suppressing drug Voquezna (vonoprazan), preventing BDR from submitting an ANDA for a generic version until 5/2032.

In a [10/21 complaint](https://storage.courtlistener.com/recap/gov.uscourts.dcd.297863/gov.uscourts.dcd.297863.1.0.pdf?ref=fdaweb.com) filed in the U.S. District Court for the District of Columbia, the India-based drugmaker argues that FDA improperly applied a 10-year exclusivity period under the Generating Antibiotic Incentives Now (GAIN) Act to a product intended to treat acid-related gastrointestinal conditions rather than bacterial or fungal infections.

The dispute centers on FDA’s application of its “umbrella policy,” under which exclusivity associated with an active ingredient can extend to other products containing the same active moiety.

FDA initially approved vonoprazan 5/2022 as part of Phathom’s Voquezna Dual Pak and Triple Pak combinations for treating *Helicobacter pylori* infection. Those products received an additional five years of exclusivity under the GAIN Act, extending protection until 5/3/2032\. The agency subsequently approved single-ingredient Voquezna tablets for acid-related conditions, including erosive esophagitis and heartburn associated with non-erosive gastroesophageal reflux disease.

According to the complaint, FDA granted a citizen petition from Phathom in June 2025, extending the GAIN exclusivity protection to the single-ingredient product, even though that product had not received a qualified infectious disease product designation.

BDR submitted its ANDA in May of this year, with proposed labeling excluding all *H. pylori* and other antibiotic-related indications. FDA rejected the submission the following day, citing the extended exclusivity period.

BDR alleges that FDA's decision violates the Administrative Procedure Act and exceeds the agency's statutory authority because the GAIN Act was intended to encourage development of treatments for serious infections, not shield unrelated acid-suppressing indications from generic competition.

The company is asking the court to vacate FDA's rejection and require the agency to recognize its ANDA as submitted on 5/3/2026 to preserve associated Hatch-Waxman patent-challenge rights and regulatory timelines.