Catalyst Pharmaceuticals settles FIRDAPSE patent litigation with Lupin.

Catalyst Pharmaceuticals has settled patent litigation with Lupin Pharmaceuticals over FIRDAPSE (amifampridine), a medication for Lambert-Eaton Myasthenic Syndrome. As part of the settlement, Lupin will receive a license to market a generic version of FIRDAPSE starting in February 2035. Catalyst and its licensor SERB will receive royalties from Lupin's sales of the generic drug. The settlement resolves a lawsuit Catalyst and SERB filed against Lupin in response to its Abbreviated New Drug Application.

Coral Gables, Fla., Aug. 25, 2025 — Catalyst Pharmaceuticals, Inc. (NASDAQ: CPRX) has announced a settlement agreement with Lupin Pharmaceuticals regarding patent litigation for FIRDAPSE® (amifampridine). Under the agreement, Lupin will receive a license to market a generic version of FIRDAPSE starting February 25, 2035, pending FDA approval. This settlement resolves the patent litigation initiated by Catalyst and SERB S.A. in response to Lupin's Abbreviated New Drug Application (ANDA).

The settlement secures FIRDAPSE patent protection until 2035, eliminating generic competition from Lupin for over a decade. This strategic move extends Catalyst's market exclusivity and revenue generation capability for the specialized medication used to treat Lambert-Eaton myasthenic syndrome (LEMS), a rare autoimmune disorder.

Catalyst has successfully settled patent litigation with Lupin, following similar arrangements with Teva Pharmaceuticals and Inventia Life Science. Only one defendant, Hetero, remains in litigation over FIRDAPSE's Orange Book-listed patents. This settlement reduces patent risk for Catalyst's core product, FIRDAPSE.

The agreement 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. This resolution demonstrates Catalyst's effective patent strategy in defending its intellectual property while avoiding the unpredictability and expense of continued litigation.

As part of the settlement, Lupin will receive a license to market a generic version of FIRDAPSE beginning in February 2035. Catalyst and its licensor SERB will receive royalties from Lupin's sales of the generic drug. The settlement resolves a lawsuit Catalyst and SERB filed against Lupin in response to its Abbreviated New Drug Application.

The settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review. Catalyst Pharmaceuticals, Inc. is a biopharmaceutical company committed to improving the lives of patients with rare diseases. With a proven track record of bringing life-changing treatments to the market, Catalyst focuses on in-licensing, commercializing, and developing innovative therapies.

[1] https://www.stocktitan.net/news/CPRX/catalyst-pharmaceuticals-announces-settlement-of-firdapse-z9zlows9jkwj.html