Catalyst Pharmaceuticals settles FIRDAPSE patent litigation with Lupin.

Catalyst Pharmaceuticals has announced a settlement with Lupin Pharmaceuticals regarding patent litigation over FIRDAPSE (amifampridine). Lupin will receive a license to market a generic version of FIRDAPSE starting in February 2035. The settlement resolves Catalyst's patent lawsuit against Lupin.

Catalyst Pharmaceuticals, Inc. (CPRX) has announced a settlement with Lupin Pharmaceuticals regarding patent litigation over Firdapse (amifampridine). Under the agreement, Lupin will receive a license to market a generic version of Firdapse starting in February 2035. The settlement resolves Catalyst's patent lawsuit against Lupin.

The settlement agreement, reached between Catalyst and its licensor, SERB, and Lupin, stipulates that Lupin will not market its generic version of Firdapse in the United States before February 25, 2035, subject to FDA approval. This agreement effectively extends Catalyst's market exclusivity for Firdapse, protecting its key revenue stream from generic competition for the next decade [1].

The settlement also includes standard provisions allowing earlier generic entry under certain limited circumstances, which is typical in pharmaceutical patent settlements. However, the baseline protection until 2035 represents a substantial commercial victory for Catalyst. This extended exclusivity period is crucial for rare disease drug manufacturers, as it allows Catalyst to continue recouping its investment while maintaining its commercial operations without immediate generic pressure [2].

The settlement requires regulatory review by the U.S. Federal Trade Commission and the U.S. Department of Justice, as mandated by law. This is a standard practice to ensure compliance with antitrust laws. Catalyst Pharmaceuticals has previously settled similar litigation regarding ANDA applications for Firdapse with Teva Pharmaceuticals and Inventia Healthcare Limited. However, litigation against Hetero remains ongoing [1].

Firdapse is Catalyst's treatment for Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder. The drug is the primary top-line driver for CPRX, accounting for 62% of the company’s net product sales in 2024. In the first half of 2025, Firdapse sales generated $168.6 million in revenues. The drug is currently approved in the United States, the EU, and Japan for the symptomatic treatment of LEMS in adults [1].

In addition to Firdapse, Catalyst Pharmaceuticals markets two other drugs in the United States—Fycompa (perampanel) CIII for epilepsy and Agamree (vamorolone) for Duchenne muscular dystrophy. However, the patents protecting Fycompa are set to expire in 2025 and 2026, which is expected to lead to a significant decline in its sales in the upcoming years due to the entry of generic alternatives [1].

Catalyst Pharmaceuticals currently carries a Zacks Rank #3 (Hold), while some better-ranked stocks in the biotech sector, such as CorMedix (CRMD), Pharming Group (PHAR), and Kiniksa Pharmaceuticals (KNSA), are sporting a Zacks Rank #1 (Strong Buy) at present. The Zacks Rank is a proprietary stock rating system that combines quantitative and qualitative analysis to provide a more comprehensive view of a company's financial health [1].

References:
[1] https://finance.yahoo.com/news/catalyst-pharmaceuticals-settles-firdapse-patent-151600307.html
[2] https://www.stocktitan.net/news/CPRX/updated-catalyst-pharmaceuticals-announces-settlement-of-firdapse-h0qqg0ym8uts.html