Catalyst Pharmaceuticals Settles Patent Litigation with Lupin, Grants License for Generic FIRDAPSE Marketing Starting February 2035
Reuters
Aug 25
Catalyst Pharmaceuticals Settles Patent Litigation with Lupin, Grants License for Generic FIRDAPSE Marketing Starting February 2035
Catalyst Pharmaceuticals Inc. has announced a settlement agreement with Lupin Ltd and Lupin Pharmaceuticals, Inc. regarding the patent litigation over FIRDAPSE® (amifampridine) 10 mg tablets. Under the terms of the agreement, Lupin will not market its generic version of FIRDAPSE in the United States before February 25, 2035, pending approval from the U.S. Food and Drug Administration. The agreement will lead to the termination of all ongoing patent litigation between Catalyst/SERB and Lupin in the U.S. District Court for the District of New Jersey. Similar litigation had previously been settled with Teva Pharmaceuticals and Inventia Life Science Pty Ltd, but litigation against Hetero regarding FIRDAPSE's Orange Book-listed patents remains ongoing. The confidential settlement agreement will be submitted to the U.S. Federal Trade Commission and the U.S. Department of Justice for review.
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