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

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  • 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.
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