Catalyst Pharmaceuticals Settles Patent Lawsuit with Lupin

Catalyst Pharmaceuticals has settled a lawsuit with Lupin Pharmaceuticals, resolving a patent dispute over the latter's request to the FDA for permission to sell a generic version of Catalyst's drug. The settlement agreement was reached between Catalyst and its licensor, SERB S.A. The terms of the agreement were not disclosed.

Coral Gables, Fla., Aug. 25, 2025 — Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX) has reached a settlement with Lupin Pharmaceuticals, resolving a patent dispute over the latter's request to the FDA for permission to sell a generic version of Catalyst's drug, FIRDAPSE® (amifampridine). The agreement was reached between Catalyst and its licensor, SERB S.A. [1]

Under the terms of the settlement, Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, pending FDA approval. This settlement resolves the patent litigation brought by Catalyst and SERB in response to Lupin's Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of FIRDAPSE prior to the expiration of the applicable patents [2].

The settlement agreement includes provisions for the termination of ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey. This follows similar settlements with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. [2]

Catalyst Pharmaceuticals has successfully secured its market exclusivity for FIRDAPSE, a treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder, for nearly a decade. This settlement is strategically significant as it prevents Lupin from launching a generic version of FIRDAPSE until February 25, 2035, extending Catalyst's market exclusivity [2].

The settlement agreement also includes standard provisions allowing for earlier generic entry under certain limited circumstances, which is typical for pharmaceutical patent settlements. These likely include scenarios such as at-risk launches by other generics or invalidation of the patents through separate proceedings [2].

Catalyst Pharmaceuticals maintains a well-established U.S. presence and has been recognized for its growth and success, appearing 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 [1].

References:
[1] https://finance.yahoo.com/news/catalyst-pharmaceuticals-announces-settlement-firdapse-120300050.html
[2] https://www.stocktitan.net/news/CPRX/catalyst-pharmaceuticals-announces-settlement-of-firdapse-z9zlows9jkwj.html