Catalyst Pharmaceuticals settles FIRDAPSE patent dispute with Lupin

Catalyst Pharmaceuticals Inc. (NASDAQ: CPRX) announced a settlement agreement with Lupin Ltd and Lupin Pharmaceuticals Inc. that resolves patent litigation over FIRDAPSE (amifampridine) 10 mg tablets.

Under the settlement terms, Lupin will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending FDA approval, unless certain limited circumstances occur. The agreement terminates ongoing patent litigation between the parties in the U.S. District Court for the District of New Jersey.

FIRDAPSE is Catalyst's treatment for patients with rare diseases. The settlement follows similar agreements Catalyst reached with Teva Pharmaceuticals and Inventia Life Science Pty Ltd regarding their ANDA applications for generic FIRDAPSE.

Patent litigation against defendant Hetero regarding FIRDAPSE's Orange Book-listed patents continues. The companies will submit the confidential settlement agreement to the Federal Trade Commission and Department of Justice for review as required by law.

Catalyst, headquartered in Coral Gables, Florida, focuses on in-licensing, developing and commercializing treatments for rare and difficult-to-treat diseases. The company maintains commercial operations primarily in the United States.

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