Xyrem (Sodium Oxybate) Antitrust Litigation

The Joseph Saveri Law Firm, LLP represents plaintiff, purchaser Self-Insured Schools of California, in a multi-district litigation (MDL) antitrust suit, In re Xyrem (Sodium Oxybate) Antitrust Litigation. Plaintiff and a potential class of other purchasers are insurers, health and welfare plans, and consumers seeking relief from indirectly paying for and/or providing reimbursement for purchases of Xyrem at supra-competitive prices. The Xyrem (Sodium Oxybate) Antitrust Litigation MDL, in the United States District Court for the Northern District of California, consists of eight similar related antitrust suits initially filed in the District and in the Southern District of New York.

Defendant Jazz is the manufacturer of Xyrem oral solution, a blockbuster drug used for the treatment of narcolepsy (chronic sleep disorder) and other related conditions. Xyrem accounts for over a billion dollars annually, which is over 70% of the company’s revenue. Loss of patent exclusivity would destroy its revenue. Price competition from generic competitors would bring competitive market forces to bear and would drive Xyrem prices down.

Facing a patent cliff, and the impact of competitive market forces, Jazz allegedly turned to an anticompetitive scheme to delay generic entry and maintain its monopoly. This scheme included, among other actions:

• Acquiring bogus patents and enforcing them with sham lawsuits
• Filing baseless citizen petitions with the FDA that had no chance of success
• Abusing the Risk Evaluation and Mitigation Strategies (REMS) system to frustrate efforts by generic manufacturers to come to market
• Entering into a series of unlawful market allocation agreements with generic competitors, including defendants Hikma Pharmaceuticals PLC, Roxane Laboratories, Inc., Amneal Pharmaceuticals LLC, Par Pharmaceutical, Inc., Lupin Pharmaceuticals, Inc., Watson Laboratories, Inc., and Mallinckrodt LLC and their parent and successor entities

Jazz also allegedly raised prices to supracompetitive levels to consumers and pursued a plan to “product hop” to avoid generic substitution laws, thereby destroying any future generic’s market share and forcing consumers to continue to pay supracompetitive prices for years in the future.

Under sections 1 and 2 of the Sherman Act and sections 4 and 16 of the Clayton Act, plaintiff seeks class action certification and overcharge damages arising from defendants’ alleged unlawful and anticompetitive tactics to maintain and allocate the monopoly in the market for indirect Xyrem purchasers in the United States and its territories. In the absence of such anticompetitive conduct, class members would have been able to buy less-expensive generic sodium oxybate instead of branded Xyrem from as early as January 17, 2017. Plaintiff also seeks injunctive and other equitable relief.

In August 2021, the Court largely refused Jazz's motion to dismiss.

In May 2023, the Court certified the Class.