Catalyst Pharmaceuticals Settles FIRDAPSE Patent Litigation with Lupin Pharmaceuticals, Granting License for Generic FIRDAPSE in 2035

Catalyst Pharmaceuticals has settled patent litigation with Lupin Pharmaceuticals for FIRDAPSE (amifampridine) 10 mg tablets, allowing Lupin to market a generic version starting February 2035. The settlement terminates ongoing patent litigation and Catalyst previously settled similar litigation with Teva Pharmaceuticals and Inventia Life Science Pty Ltd. The pending patent litigation against Hetero remains ongoing.

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) has announced a settlement agreement with Lupin Pharmaceuticals regarding the patent litigation for FIRDAPSE® (amifampridine) 10 mg tablets. Under the agreement, Lupin will receive a license to market a generic version of FIRDAPSE starting February 25, 2035, pending FDA approval [2]. The settlement resolves the patent litigation initiated by Catalyst and SERB S.A. in response to Lupin’s Abbreviated New Drug Application (ANDA) [3].

The agreement stipulates that Lupin will not market its generic version of FIRDAPSE in the United States any earlier than February 25, 2035, unless certain limited circumstances occur. This agreement terminates all ongoing patent litigation between Catalyst and Lupin regarding FIRDAPSE patents pending in the U.S. District Court for the District of New Jersey [2].

This settlement follows similar arrangements with Teva Pharmaceuticals and Inventia Life Science Pty Ltd., while litigation against Hetero remains ongoing. The pending FIRDAPSE patent litigation against Hetero regarding FIRDAPSE’s Orange Book-listed patents is ongoing [1].

The settlement provides critical certainty for Catalyst's revenue stream, extending its market exclusivity for FIRDAPSE by nearly a decade. FIRDAPSE treats Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder, and represents Catalyst's primary commercial product [3].

Catalyst Pharmaceuticals has successfully settled three out of four ANDA challenges, significantly reducing patent risk for its core product. The settlement includes standard provisions allowing for earlier generic entry under certain limited circumstances, which is typical for pharmaceutical patent settlements [3].

This resolution demonstrates Catalyst's effective patent strategy in defending its intellectual property while avoiding the unpredictability and expense of continued litigation. With three of four ANDA challengers now settled, Catalyst has substantially reduced patent risk for its core product.

References
[1] https://www.tradingview.com/news/reuters.com,2025:newsml_TUA6CYCQB:0-catalyst-pharmaceuticals-announces-settlement-of-firdapse-amifampridine-patent-litigation-with-lupin-pharmaceuticals/
[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
[3] https://www.stocktitan.net/news/CPRX/catalyst-pharmaceuticals-announces-settlement-of-firdapse-z9zlows9jkwj.html