Catalyst Pharmaceuticals Resolves FIRDAPSE Patent Litigation with Lupin Pharmaceuticals, Upholding Exclusivity Until 2035.

Catalyst Pharmaceuticals has settled patent litigation with Lupin Pharmaceuticals, allowing Lupin to market a generic version of FIRDAPSE in the US no earlier than February 25, 2035. The settlement ends ongoing litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents in the US District Court for the District of New Jersey. The companies will submit the agreement to the US Federal Trade Commission and US Department of Justice for review.

Catalyst Pharmaceuticals (CPRX) has reached a significant milestone in its ongoing patent disputes by settling litigation with Lupin Pharmaceuticals. The agreement, announced on July 2, 2025, allows Lupin to market a generic version of FIRDAPSE (amifampridine) in the United States, but not until February 25, 2035, pending FDA approval [1].

The settlement resolves the ongoing litigation between Catalyst and SERB (the licensor) and Lupin, which was initiated due to Lupin's Abbreviated New Drug Application (ANDA) seeking marketing approval for a generic version of FIRDAPSE before the applicable patents expired. This agreement extends Catalyst's market exclusivity for FIRDAPSE, which is crucial for its revenue stream, especially given the drug's primary role in treating Lambert-Eaton Myasthenic Syndrome (LEMS) [1].

The settlement agreement includes provisions that terminate all ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey. It also mandates that the confidential settlement agreement be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for regulatory review, as required by law [1].

This settlement is a significant victory for Catalyst, following similar successful patent defenses against Teva Pharmaceuticals and Inventia Healthcare Limited. The company continues to face one remaining patent challenge from Hetero, which remains ongoing [1]. 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 extended exclusivity period until 2035 is particularly beneficial for Catalyst, as it allows the company to continue recouping its investment in FIRDAPSE while maintaining its commercial operations without immediate generic pressure. This is crucial for rare disease drug manufacturers, who often face significant investment and commercialization challenges for small patient populations [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 [1].

In addition to FIRDAPSE, Catalyst markets two other drugs in the United States: Fycompa (perampanel) for epilepsy and Agamree (vamorolone) for Duchenne muscular dystrophy. These drugs generate incremental revenues for the company, easing the burden on FIRDAPSE for revenue generation. However, the patents protecting Fycompa are set to expire in 2025 and 2026, which may lead to a significant decline in sales due to the entry of generic alternatives [1].

Catalyst Pharmaceuticals currently carries a Zacks Rank #3 (Hold), indicating a neutral outlook. However, the company's focus on rare diseases and its track record of successful patent defenses make it an interesting player in the biotech sector [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