Hagens Berman represents Blue Cross Blue Shield Association and Government Employees Health Association and is part of the plaintiffs’ steering committee in this lawsuit that alleges Jazz Pharmaceuticals Inc. engaged in anticompetitive behavior with the intention of impairing and delaying generic competition for its brand drug Xyrem (sodium oxybate).
ABOUT THE XYREM LAWSUIT
The complaint asserts that Jazz filed suits against drug manufactures who filed applications with the FDA to sell generic versions of Xyrem in order to maintain its exclusivity in the market. Jazz also entered into reverse-payment agreements with these would-be manufacturers, which compelled them to delay the entry of their generics from January 2018 to July 2023.
Jazz’s final attempt to deter potential competitors took advantage of Xyrem’s restricted distribution. Because the drug is made from a sodium salt of gamma-hydroxybutrate (GHB), which is a commonly known as a date-rape drug, the approval of Xyrem and any generic equivalents requires a risk management system in order to deter abuse.
Jazz implemented a patented distribution plan that operated through a single pharmacy as part of this system with the objective of frustrating potential generic manufacturers’ efforts to obtain approval for their generics.
The complaint identifies further allegations against Jazz related to its efforts to delay generic entry; Jazz prosecuted multiple frivolous citizen petitions before the FDA in an effort to delay approval of the generics. Jazz also engaged in a product-hop, in which it filed a new drug application for a follow-up drug in order to obtain another round of patent exclusivity and maintain market power.