Catalyst Pharma Shares Take A Hit As Teva Files For Generic Version Of Its Lead Product

Catalyst Pharmaceuticals Inc CPRX has received a Notice Letter stating that Teva Pharmaceutical Industries Ltd TEVA submitted an abbreviated marketing application to the FDA for a generic version of Firdapse in the U.S.
In the Notice Letter, Teva states that it intends to market a generic version of Firdapse before the expiration of Catalyst's patents covering U.S. patents expiring up to February 2037.
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.
Catalyst has 45 days to commence a patent infringement lawsuit in a federal district court against Teva to trigger a stay precluding the FDA from approving Teva's ANDA until May 2026 or entry of judgment holding the patents invalid, unenforceable, or not infringed, whichever occurs first.
Catalyst is currently assessing the Notice Letter and intends to enforce its intellectual property rights relating to Firdapse.
In Q3 FY22, Catalyst Pharmaceuticals recorded Firdapse sales of $57.2 million, up 59.3% Y/Y and a 7.8% increase compared to Q2 2022.
The FDA approved Firdapse (amifampridine) for adults with Lambert-Eaton myasthenic syndrome, a condition in which the immune system attacks the neuromuscular junctions (areas where your nerves and muscles connect).
Price Action: CPRX shares are down 31.9% at $14.17 on the last check Monday.