Catalyst Pharmaceuticals announced a significant patent settlement with Lupin Pharmaceuticals that secures market exclusivity for FIRDAPSE (amifampridine) 10 mg tablets until February 25, 2035. The agreement resolves patent litigation that arose when Lupin filed an Abbreviated New Drug Application (ANDA) seeking to market a generic version of the rare disease treatment before patent expiration.
Settlement Terms Provide Long-Term Protection
Under the settlement agreement between Catalyst, its licensor SERB S.A., and Lupin Ltd and Lupin Pharmaceuticals, Inc., Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, pending FDA approval. The agreement includes standard limited circumstances that could potentially alter this timeline, as is customary in pharmaceutical patent settlements.
The settlement terminates all ongoing patent litigation between Catalyst/SERB and Lupin regarding FIRDAPSE patents that were pending in the U.S. District Court for the District of New Jersey. As required by federal law, the companies will submit the confidential settlement agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice for regulatory review.
Strategic Patent Defense Campaign
This settlement represents the latest success in Catalyst's comprehensive patent defense strategy for FIRDAPSE. The company previously settled similar litigation regarding ANDA applications with Teva Pharmaceuticals and Inventia Life Science Pty Ltd, demonstrating a systematic approach to protecting its intellectual property rights.
However, patent litigation remains active against one remaining defendant. The pending FIRDAPSE patent litigation against Hetero regarding the drug's Orange Book-listed patents continues, representing the final outstanding challenge to Catalyst's patent protection.
Commercial Implications for Rare Disease Treatment
FIRDAPSE serves patients living with rare and difficult-to-treat diseases, making patent protection particularly significant for maintaining treatment access and continued research investment. Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company based in Coral Gables, Florida, focuses on in-licensing, developing, and commercializing novel medicines for underserved patient populations.
The company has established recognition for its growth trajectory, earning placement on the Forbes 2025 list as one of America's Most Successful Mid-Cap Companies and the 2024 Deloitte Technology Fast 500™ list as one of North America's Fastest-Growing Companies.
The settlement provides Catalyst with extended commercial exclusivity that could significantly impact the company's long-term revenue projections and ability to invest in additional rare disease treatments. With generic competition now delayed until 2035, the company maintains pricing power and market position for more than a decade.
