Court Sides With FTC, Orders Delisting Of Narcolepsy Drug REMS Patent

By Gabrielle Wanneh, Beth Wang / November 23, 2022 at 4:28 PM
Correction: This is story has been updated to correctly state the litigation that was referenced by Hyman, Phelps & McNamara's Sara Koblitz. A district court judge in Delaware has ordered Jazz Pharmaceuticals to remove its risk evaluation and mitigation strategy (REMS) distribution patent for the narcolepsy treatment Xyrem (sodium oxybate) from FDA’s Orange Book, agreeing with the Federal Trade Commission that it was an improper listing that impedes competition. The move could hike pressure on FDA to...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.