FIRDAPSE (amifampridine)

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Catalyst Pharmaceuticals Announces Settlement of FIRDAPSE® (amifampridine) Patent Litigation with Lupin Pharmaceuticals
Globenewswire· 2025-08-25 12:03
Core Viewpoint - Catalyst Pharmaceuticals and SERB have reached a settlement with Lupin regarding the patent litigation over FIRDAPSE, allowing Lupin to market a generic version starting February 25, 2035, pending FDA approval [1][2]. Group 1: Settlement Agreement Details - The settlement agreement resolves ongoing patent litigation between Catalyst/SERB and Lupin concerning FIRDAPSE [2]. - Lupin is prohibited from marketing its generic version of FIRDAPSE in the U.S. before February 25, 2035, unless specific circumstances arise [2]. - The agreement includes the termination of all ongoing patent litigation related to FIRDAPSE patents in the U.S. District Court for the District of New Jersey [2]. Group 2: Company Background - Catalyst Pharmaceuticals is focused on developing and commercializing treatments for rare diseases and has a strong commitment to patient care [4]. - The company has been recognized on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and on the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies [4].