Catalyst Pharmaceuticals, Inc. (CPRX), a commercial-stage biopharmaceutical company, announced on Wednesday that it has reached a settlement with Teva Pharmaceuticals regarding the patent litigation over its drug FIRDAPSE or amifampridine.
FIRDAPSE is a prescription medicine used to treat Lambert-Eaton myasthenic syndrome or LEMS in people 6 years of age or older. It is not known if FIRDAPSE is safe or effective in children less than 6 years of age.
The settlement resolves the ongoing dispute stemming from Teva's attempt to market a generic version of FIRDAPSE before the expiration of its patents.
Under the terms of the agreement, Teva will be granted a license to market a generic version of FIRDAPSE starting in February 2035, pending FDA approval.
This settlement also results in the termination of all ongoing patent litigation between Catalyst/SERB and Teva in the U.S. District Court for the District of New Jersey.
Catalyst CEO, Patrick McEnany, commented, "We are pleased to have reached a resolution with Teva and believe this agreement solidifies FIRDAPSE's market exclusivity for many more years to come."
The litigation against other defendants, Hetero and Lupin, continues, with Catalyst actively defending its intellectual property rights.
As required, the confidential license agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
Catalyst Pharmaceuticals is focused on developing treatments for rare diseases and continues to protect its intellectual property for FIRDAPSE, a key asset in its portfolio.
FIRDAPSE's Net Product Revenues of $79.3 million in 2024, marking a 19.7% Increase compared to $66.2 million in 2023.
The company had a cash and cash equivalents $442.3 million as of September 30, 2024.
Currently, CPRX is trading at $22.58 up by 15.21%.
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