BDR sues FDA over exclusivity extension for Phathom's Voquezna

• BDR Pharmaceuticals sued the FDA in federal court in Washington, D.C., challenging exclusivity protections for Phathom Pharmaceuticals' VOQUEZNA tablets.
• The lawsuit alleges the FDA improperly applied the GAIN Act to extend exclusivity, blocking receipt of BDR's generic drug application.
• The FDA recognized 10 years of exclusivity through May 3, 2032, when granting a citizen petition on June 6, 2025.
• Phathom believes the FDA correctly evaluated the issue and intends to protect its statutory exclusivities.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Phathom Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610230400PRIMZONEFULLFEED9851876) on October 23, 2026, and is solely responsible for the information contained therein.