Catalyst Pharmaceuticals settles patent litigation with Lupin over FIRDAPSE.

Catalyst Pharmaceuticals has entered into a settlement agreement with Lupin Ltd, resolving patent litigation over Lupin's Abbreviated New Drug Application for a generic version of FIRDAPSE. Lupin will not market its generic version in the US until February 25, 2035, if approved by the FDA. The agreement ensures the protection of Catalyst's intellectual property rights.

Coral Gables, Fla., Aug. 25, 2025 (GLOBE NEWSWIRE) – Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), a biopharmaceutical company focused on in-licensing, developing, and commercializing novel medicines for patients living with rare and difficult-to-treat diseases, has announced a significant settlement agreement with Lupin Pharmaceuticals. The agreement resolves ongoing patent litigation over Lupin's Abbreviated New Drug Application (ANDA) for a generic version of FIRDAPSE® (amifampridine).

Under the terms of the settlement, Lupin will not market its generic version of FIRDAPSE in the United States until February 25, 2035, if approved by the U.S. Food and Drug Administration (FDA). This agreement effectively extends Catalyst's market exclusivity for the drug by approximately a decade.

The settlement agreement also includes standard provisions allowing for earlier generic entry under certain limited circumstances, such as at-risk launches by other generics or invalidation of the patents through separate proceedings. All ongoing patent litigation between Catalyst and Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey will be terminated.

This resolution is part of Catalyst's strategic patent defense efforts, which have already resulted in successful settlements with Teva Pharmaceuticals and Inventia Life Science. Only one defendant, Hetero, remains in litigation over FIRDAPSE's Orange Book-listed patents.

The agreement underscores Catalyst's commitment to protecting its intellectual property and ensuring the continued availability of FIRDAPSE, a critical treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. By securing this settlement, Catalyst has secured its market position and revenue generation capability for this specialized medication.

Catalyst Pharmaceuticals, Inc. maintains a well-established U.S. presence and continues to evaluate strategic opportunities to expand its global footprint. The company was recently 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.

[1] https://www.stocktitan.net/news/CPRX/catalyst-pharmaceuticals-announces-settlement-of-firdapse-z9zlows9jkwj.html
[2] https://www.globenewswire.com/news-release/2025/08/25/3138433/13009/en/Catalyst-Pharmaceuticals-Announces-Settlement-of-FIRDAPSE-amifampridine-Patent-Litigation-with-Lupin-Pharmaceuticals.html