08:52 AM EDT, 08/25/2025 (MT Newswires) -- Catalyst Pharmaceuticals ( CPRX ) and its licensor SERB have reached a settlement agreement with Lupin Pharmaceuticals to resolve patent litigation brought by Catalyst against Lupin's Abbreviated New Drug Application to market a generic version of Catalyst's Firdapse prior to expiration of the applicable patents, Catalyst said Monday.
Under terms of the settlement, Lupin will not market its generic Firdapse, or amifampridine, in the US earlier than Feb. 25, 2035, if its Abbreviated New Drug Application is approved by the US Food and Drug Administration, Catalyst said. The companies now have to submit their confidential settlement agreement to the US Federal Trade Commission and US Department of Justice for review.
Catalyst has previously settled similar lawsuits with Teva Pharmaceuticals (TEVA) and Inventia Life Science.
Currently, pending Firdapse patent litigation against Hetero remains ongoing, Catalyst noted.
Catalyst shares were up 2.5% in recent Monday premarket activity.