Catalyst Pharmaceuticals Secures Exclusivity for FIRDAPSE Until 2035

Catalyst Pharmaceuticals secured market exclusivity for FIRDAPSE until 2035 through a settlement with Lupin Ltd, delaying generics until February 25, 2035, pending FDA approval. The company reported a 19.4% YoY revenue increase in Q2 2025, reflecting expanding market reach and commercial momentum. Catalyst maintains strategic collaborations and is recognized for its innovative rare disease pipeline, reinforcing its appeal to investors seeking growth in specialty biopharma.

Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) has secured market exclusivity for its flagship product, FIRDAPSE (amifampridine), through a settlement with Lupin Ltd. The agreement, announced on August 26, 2025, delays the entry of generic versions of FIRDAPSE in the United States until February 25, 2035, pending FDA approval. This settlement protects Catalyst's revenue stream from generic competition for nearly a decade.

The settlement resolves ongoing patent litigation between Catalyst and Lupin over FIRDAPSE 10 mg tablets, following similar settlements with Teva Pharmaceuticals and Inventia Healthcare Limited. The agreement includes standard provisions allowing earlier generic entry under certain limited circumstances, but the baseline protection until 2035 represents a significant commercial victory for Catalyst.

FIRDAPSE is a treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. By securing this settlement, Catalyst has eliminated the uncertainty and costs associated with continued litigation while maintaining extended market protection for its flagship product. The company still faces one remaining patent challenge from Hetero, which remains ongoing.

Catalyst reported a 19.4% year-over-year (YoY) revenue increase in Q2 2025, reflecting expanding market reach and continued commercial momentum. The company maintains strategic collaborations and is recognized for its innovative rare disease pipeline, reinforcing its appeal to investors seeking growth in specialty biopharma.

References:
[1] https://finance.yahoo.com/news/catalyst-pharmaceuticals-inc-cprx-secures-085410733.html
[2] https://www.stocktitan.net/news/CPRX/updated-catalyst-pharmaceuticals-announces-settlement-of-firdapse-h0qqg0ym8uts.html