Catalyst Pharmaceuticals secures Firdapse patent protection through 2035 in Hetero settlement

Catalyst Pharmaceuticals (NASDAQ:CPRX) and its licensor, SERB, have successfully resolved their patent litigation with Hetero and its affiliates regarding Firdapse (amifampridine) 10 mg tablets.

The settlement provides Catalyst with nearly a decade of additional market exclusivity for its flagship treatment for Lambert-Eaton myasthenic syndrome (LEMS).

Under the terms of the agreement, Hetero is prohibited from marketing a generic version of Firdapse in the United States until a specified date in January 2035, pending approval from the U.S. Food and Drug Administration.

The resolution effectively preserves Catalyst’s revenue stream for its primary asset by staving off low-cost generic competition for the next nine years.

The settlement brings an end to all related U.S. district court cases, which were originally scheduled to proceed to trial on May 18, 2026.

By reaching an agreement before the trial date, Catalyst avoids the costs and legal uncertainties associated with a protracted courtroom battle.

As required by law, the confidential settlement will be submitted to the U.S. Federal Trade Commission (FTC) and the Department of Justice (DOJ) for a standard regulatory review.

This process is typical for "pay-for-delay" or patent settlement agreements in the pharmaceutical industry to ensure they do not violate antitrust regulations.