Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC, No. 24-2274 (Fed. Cir. May 6, 2025)

From the Opinion

The passage below is extracted verbatim from the opening of the document. It has not been editorially summarized — consult the full opinion for the court's complete reasoning.

Avadel CNS Pharmaceuticals, LLC (“Avadel”) appeals from the decision of the U.S. District Court for the District of Delaware permanently enjoining it from seeking ap- proval from the U.S. Food and Drug Administration (“ the FDA”) of its product, Lumryz, for the treatment of idio- pathic hypersomnia, as well as from marketing Lumryz for that indication. Jazz Pharms., Inc. v. Avadel CNS Pharms. LLC, No. 21-cv-691, 2024 WL 4005200 (D. Del. Aug. 27, 2024) (“ Permanent Injunction Order”); see Jazz Pharms., Inc. v. Avadel CNS Pharms. LLC, No.