Catalyst Resolves Patent Dispute

Catalyst Pharmaceuticals, Inc. (Nasdaq: CPRX), a biopharmaceutical company specializing in rare and hard-to-treat diseases, announced a resolution of its patent litigation with Teva Pharmaceuticals USA, Inc. The settlement pertains to Teva’s effort to bring a generic version of Catalyst’s flagship drug, FIRDAPSE® (amifampridine) 10 mg tablets, to market.

Key Terms of the Agreement

Under the settlement:

• Teva has agreed not to launch its generic version of FIRDAPSE in the U.S. before February 25, 2035, provided FDA approval is secured and certain typical exceptions do not apply.
• Ongoing patent litigation between Catalyst, its licensor SERB S.A., and Teva will be terminated in the U.S. District Court for the District of New Jersey.
• Litigation concerning FIRDAPSE patents with other defendants, Hetero and Lupin, remains active.

Next Steps

The confidential license agreement will now undergo a mandatory review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice (DOJ), as required by law.

Catalyst’s Commitment

This settlement underscores Catalyst’s dedication to protecting its intellectual property and ensuring continued access to FIRDAPSE for patients with rare diseases. The drug is a critical treatment for those living with Lambert-Eaton myasthenic syndrome (LEMS) and other conditions requiring amifampridine.

Catalyst’s management reaffirmed their commitment to supporting patients while pursuing ongoing litigation to safeguard their patents and pipeline.