Jazz Pharmaceuticals has adopted a new strategy by filing a lawsuit after years of relying on the patent system to impede competition from a rival company and exhausting their options earlier this year. Jazz is suing the FDA for granting authorization to Avadel Pharmaceuticals’ narcolepsy medication, Lumryz, which poses a significant threat to Jazz’s successful Xyrem/Xywav business.
In court, Jazz argued that the approval granted to Lumryz on May 1 was “illegal.” According to Jazz, this clearance violated the orphan drug exclusivity (ODE) status granted to Xywav by the FDA in 2021.
The FDA determined that Lumryz is superior to Jazz’s products, granting it its own ODE and acknowledging its potential to greatly improve patient care due to its convenience and additional therapeutic value. While Lumryz only requires one dose at night, Xywav requires two. Both medications are oral suspensions.
Jazz contends that the FDA acted unlawfully because Avadel never conducted a clinical investigation comparing Lumryz to Xywav, and deems the FDA’s action unethical.
The lawsuit by Jazz Pharmaceuticals Against FDA Decision Regarding Xywav
- Jazz Pharmaceuticals filed a lawsuit challenging the FDA’s decision, asserting that it is incorrect.
- The FDA acknowledged the enhanced safety of Xywav due to its reduced sodium, a departure from their traditional policy.
- The FDA typically requires a sponsor of a new drug to demonstrate its safety and effectiveness compared to an already-approved orphan drug.
- The FDA declined to comment on the ongoing litigation.
- Jazz Pharmaceuticals aims to safeguard its major revenue-generating products, which contributed $1.98 billion in sales last year, constituting 54% of the company’s total revenue.
An extended-release version of high-sodium oxybate called Xyrem was approved in 2002. In 2020, Jazz received FDA clearance for its successor oxybate, Xywav, which contains 92% less sodium. Jazz’s medications have been the standard treatment for narcolepsy for the past 20 years.
Jazz attempted to prevent Avadel from launching Lumryz in the market by securing patents related to the creation of Xywav. When the FDA provisionally endorsed Lumryz in July of last year, the approval was contingent upon the validity of a Jazz patent.
In February of this year, a U.S. court ordered Jazz to remove the patent from the FDA’s list of authorized medications. Avadel successfully argued that the patent only applied to Jazz’s distribution of the medication, not its creation or application.
Over the years, strict drug regulations have facilitated Jazz’s patent strategy. Gamma-hydroxybutyrate, the main ingredient in sodium oxybate, was initially used to induce sleep in women during childbirth in the 1960s. Later on, its illicit counterpart became known as the date rape drug. At lower doses, it can induce euphoria and increased sexual desire, while higher doses can render a person unconscious.
