Catalyst Pharmaceuticals Settles Firdapse Patent Litigation With Lupin

Core Viewpoint - Catalyst Pharmaceuticals (CPRX) has entered into a settlement agreement with Lupin Pharmaceuticals regarding patent litigation over Firdapse, which protects the company's sales from generic competition until February 25, 2035 [1][5][6]. Group 1: Firdapse Overview - Firdapse is approved in the U.S., EU, and Japan for treating Lambert-Eaton Myasthenic Syndrome (LEMS) in adults and has recently expanded its label to include pediatric patients aged six and older [2]. - In 2024, Firdapse accounted for 62% of Catalyst Pharmaceuticals' sales, generating $168.6 million in revenue in the first half of 2025 [5][8]. Group 2: Settlement Details - The settlement prohibits Lupin from marketing its generic version of Firdapse in the U.S. before February 25, 2035, unless specific exceptions arise [6]. - The agreement also resolves all ongoing patent litigation between Catalyst Pharmaceuticals/SERB and Lupin in the U.S. District Court in New Jersey [6][7]. Group 3: Other Products and Market Position - Catalyst Pharmaceuticals markets two additional drugs in the U.S.: Fycompa for epilepsy and Agamree for Duchenne muscular dystrophy, which provide incremental revenue [9]. - The patents for Fycompa are set to expire in 2025 and 2026, leading to anticipated declines in sales due to increased competition from generics [10].