BDR sues FDA over VOQUEZNA NCE exclusivity; Phathom defends 10-year term to May 2032

Phathom Pharmaceuticals, Inc.

BDR Pharmaceuticals International Pvt. Ltd. sued FDA and related Federal Defendants in the U.S. District Court for the District of Columbia over an ANDA referencing Phathom's VOQUEZNA NDA.
BDR alleges FDA improperly applied the GAIN Act to extend Phathom's New Chemical Entity exclusivity for VOQUEZNA (vonoprazan fumarate) tablets.
Phathom says FDA correctly recognized 10 years of NCE exclusivity through May 3, 2032 in its June 6, 2025 grant of Phathom's December 11, 2024 Citizen Petition.
Phathom intends to take appropriate action to protect its statutory exclusivities; it warns an adverse outcome could shorten exclusivity and allow ANDAs earlier.

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