Catalyst Pharmaceuticals notified of ANDA filing for FIRDAPSE

Catalyst Pharmaceuticals (CPRX) announced that it has received a Paragraph IV Certification Notice Letter from Teva Pharmaceuticals (TEVA) advising that Teva had submitted an Abbreviated New Drug Application, ANDA, to the U.S. Food and Drug Administration, FDA, seeking authorization from the FDA to manufacture, use or sell a generic version of FIRDAPSE in the United States. In the Notice Letter, Teva states that it intends to market a generic version of FIRDAPSE before the expiration of Catalyst’s patents listed in the FDA Orange Book covering FIRDAPSE: U.S. Patent Numbers 10,626,088; 10,793,893; 11,060,128; 11,268,128; 11,274,331; and 11,274,332. Teva’s Notice Letter states that its ANDA contains a Paragraph IV Certification alleging that these patents are not valid, not enforceable, and/or will not be infringed by the commercial manufacture, use or sale of the proposed product described in Teva’s ANDA submission. Under the Federal Food, Drug, and Cosmetic Act, as amended by the Drug Price Competition and Patent Term Restoration Act of 1984, as amended, Catalyst has 45 days from receipt of the Notice Letter to commence a patent infringement lawsuit in a federal district court against Teva to trigger a stay precluding FDA from approving Teva’s ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.