Phathom seeks to intervene in lawsuit challenging Voquezna exclusivity
PHAT•Phathom Pharmaceuticals moved to intervene in BDR Pharmaceuticals’ lawsuit challenging the FDA’s decision recognizing 10 years of exclusivity for VOQUEZNA through May 3, 2032.
1. Exclusivity lawsuit
Phathom Pharmaceuticals moved to intervene in BDR Pharmaceuticals’ lawsuit against the FDA to defend VOQUEZNA’s regulatory exclusivity. BDR challenges the FDA’s June 6, 2025, decision recognizing 10 years of new chemical entity exclusivity through May 3, 2032. The FDA set November 23, 2026, as the deadline for public comments on legal and regulatory issues raised in the litigation. Saba Ilac Sanayii Ve Ticaret AS intends to seek consolidation of its related case with BDR’s lawsuit.
