Catalyst Pharmaceuticals Inc CPR Shares are trading up 13.46% at $18.00 on Monday morning after Teva Pharmaceuticals announced it would sell a generic version of Catalyst’s FIRDAPSE in the United States.

What happened?

In the letter of notification, Teva states that it intends to commercialize a generic version of FIRDAPSE® before several of Catalyst’s patents listed in the FDA’s Orange Book expire.

Teva’s letter of communication states that its ANDA contains a Paragraph IV certification alleging that these patents are invalid, unenforceable, and/or caused by the commercial manufacture, use, or sale of the proposed product in Teva’s ANDA submission is not violated.

According to Catalyst, the company has 45 days from receipt of the notification letter to file a patent infringement lawsuit against Teva in a federal district court to trigger a stay preventing the FDA from approving Teva’s ANDA until May 2026, or to issue a judgment that the patents to be invalid, unenforceable, or not infringed, whichever occurs first.

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Catalyst Pharmaceuticals is focused on developing and commercializing innovative therapies for people living with rare, debilitating, chronic neuromuscular and neurological disorders

According to data from Gasoline ProCPRX has a 52-week high of $22.11 and a 52-week low of $5.24.