Jazz Pharma Must Delist Xyrem Patent in Win for Rival Avadel (1)

Jazz Pharmaceuticals Inc. must ask the US Food and Drug Administration to remove a key patent for Xyrem, its twice-nightly narcolepsy drug, from its registry of approved drugs.

Avadel CNS Pharmaceuticals LLC had renewed its motion for an order that Jazz request the delisting of Patent No. 8,731,963 from the FDA Orange Book, which was granted by Judge Gregory B. Williams. The patent “does not claim a drug for which the application was approved or an approved method of using the drug,” he said in an opinion issued Friday for the US District Court for the District of Delaware. ...