Phathom Pharmaceuticals Provides Update on FDA Litigation

Phathom disclosed that the FDA has opened a public docket (FDA-2026-N-13038) on legal questions raised by ANDA filer BDR Pharmaceuticals, which is suing the FDA to challenge the agency's June 2025 decision granting VOQUEZNA 10 years of NCE exclusivity through May 3, 2032. Phathom has moved to intervene in the litigation to defend its exclusivity, and a second purported ANDA filer, Saba Ilac, has signaled intent to consolidate its case with BDR's. Comments on the docket are due November 23, 2026.

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