Catalyst settles Firdapse patent litigation with Hetero, bars US generic until 2035

Catalyst Pharmaceuticals, Inc.

Catalyst Pharmaceuticals, Inc.

CPRX

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  • Catalyst Pharmaceuticals reached a settlement with Hetero Labs to end patent litigation tied to Hetero’s ANDA for a generic version of FIRDAPSE (amifampridine) 10 mg tablets.
  • Deal grants Hetero a license to launch a US generic no earlier than a specified date in January 2035, subject to customary exceptions.
  • Parties will terminate the New Jersey federal court case ahead of a May 18, 2026 trial date.
  • Settlement clears remaining FIRDAPSE patent litigation, following earlier deals with Lupin, Teva, and Inventia.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Catalyst Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605070244PRIMZONEFULLFEED9715292) on May 07, 2026, and is solely responsible for the information contained therein.