After years of using the patent system to delay competition from a rival company and then exhausting that ploy early this year, Jazz Pharmaceuticals is taking a new route—suing the FDA.
Jazz is challenging the regulator for approving Avadel Pharmaceuticals’ narcolepsy drug Lumryz, which poses a major threat to Jazz’s blockbuster Xyrem/Xywav franchise.
In U.S. district court in Washington, D.C., Jazz claimed that the green light for Lumryz—which was awarded on May 1—was “unlawful.” The Dublin company says that the approval violated the orphan drug exclusivity (ODE) the agency granted to Xywav in 2021.
In awarding Lumryz its own ODE, the FDA ruled that Lumryz is superior to Jazz’s offerings, citing its ability to make a major contribution to patient care based on its convenience and additional clinical benefit. While Lumryz is taken once a night, Xywav requires two doses. Both are oral suspension drugs.
Jazz maintains that the FDA acted improperly because Avadel never pitted Lumryz against Xywav in a clinical trial.
“Because FDA acknowledged Xywav’s greater safety due to reduced sodium, FDA’s determination is inconsistent with longstanding FDA policy that requires a sponsor seeking a determination that the proposed new drug will make a major contribution to patient care to demonstrate that [it] is comparably as safe and effective as a previously approved same orphan drug,” Jazz wrote in a regulatory filing which announced the lawsuit.
In an email, the FDA said it does not comment on "possible, pending or ongoing litigation."
Jazz is trying to protect its most important products which generated a combined $1.98 billion in sales last year representing 54% of the company’s revenue.
Lumryz is an extended-release reformulation of Xyrem, a high-sodium oxybate that was approved in 2002. In 2020, Jazz scored FDA approval for follow-on oxybate Xywav, which contains 92% less sodium. For two decades, Jazz’s drugs have been the standard of care for narcolepsy.
In erecting patents related to the development of Xywav, Jazz tried to prevent its crosstown rival Avadel from bringing Lumryz to the market. In July of last year, when the FDA tentatively approved Lumryz, the endorsement was contingent upon the status of a Jazz patent.
In February of this year, a U.S. appeals court ordered Jazz to delist the patent from the FDA’s register of approved medications (Orange Book). Avadel successfully argued that the patent related to how Jazz distributed the drug, not to its formulation or how it is used.
Jazz’s patent strategy over the years has been facilitated by tight controls on the drug. The key component of sodium oxybate is gamma-hydroxybutyrate, which was used in the 1960s to induce drowsiness during childbirth, The New York Times reports. Decades later, an illegal version of the treatment became known as the “club drug” or “date rape drug.” At lower doses, it can provide euphoria and sexual arousal. At higher doses, it can induce unconsciousness.