Why Catalyst Pharmaceuticals Shares Are Moving

Catalyst Pharmaceuticals Inc CPRX shares are trading lower by 13.46% to $18.00 Monday morning after Teva Pharmaceuticals stated it plans to sell a generic version of Catalyst's FIRDAPSE in the United States.

What Happened?

In the Notice Letter, Teva states that it intends to market a generic version of FIRDAPSE® before the expiration of multiple of Catalyst's patents listed in the FDA Orange Book.

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.

Catalyst says the company 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.

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Catalyst Pharmaceuticals focuses on developing and commercializing innovative therapies for people with rare, debilitating, chronic neuromuscular and neurological diseases

According to data from Benzinga Pro, CPRX has a 52-week high of $22.11 and a 52-week low of $5.24.