Source – Jazz Pharmaceuticals
In a legal battle against the FDA, Jazz Pharmaceuticals alleges that the agency violated the orphan drug exclusivity granted to one of its narcolepsy medications in 2021. The company’s lawsuit comes after utilizing patent strategies to delay competition and subsequently exhausting those tactics earlier this year.
Jazz Pharmaceuticals is now suing the FDA for approving Avadel Pharmaceuticals’ narcolepsy drug, Lumryz, which poses a significant threat to Jazz’s highly successful Xyrem/Xywav franchise.
The lawsuit, filed in a US district court in Washington, DC, claims that the approval of Lumryz on May 1 was “unlawful.” Jazz argues that this approval violated the orphan drug exclusivity (ODE) granted to Xywav by the FDA in 2021.
The FDA, in granting Lumryz its own ODE, deemed it superior to Jazz’s offerings due to its convenience and additional clinical benefit. Lumryz is taken once a night, while Xywav requires two doses. Both drugs are oral suspensions.
Jazz asserts that the FDA’s actions were improper since Avadel did not conduct a clinical trial comparing Lumryz directly against Xywav.
Jazz stated in a regulatory filing announcing the lawsuit, “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.”
The FDA declined to comment on the ongoing litigation. Jazz Pharmaceuticals aims to protect its vital products, which generated $1.98 billion in combined sales last year, accounting for 54% of the company’s revenue.
Lumryz is an extended-release formulation of Xyrem, a high-sodium oxybate that received approval in 2002. In 2020, Jazz obtained FDA approval for Xywav, a follow-on oxybate with 92% less sodium. For the past two decades, Jazz’s drugs have been the standard of care for narcolepsy.
Jazz previously employed patent strategies to impede Avadel’s introduction of Lumryz to the market. When the FDA tentatively approved Lumryz in July of last year, it was contingent upon the status of a Jazz patent.
However, in February of this year, a US appeals court instructed Jazz to remove the patent from the FDA’s register of approved medications (Orange Book). Avadel successfully argued that the patent pertained to how Jazz distributed the drug, rather than its formulation or usage.
Jazz’s patent strategy has been successful due to stringent controls on the drug. The primary ingredient in sodium oxybate, gamma-hydroxybutyrate, was previously utilized in the 1960s to induce sleepiness during childbirth, as reported by The New York Times. However, an illicit version of this treatment emerged years later, commonly known as the “club drug” or “date rape drug.” When administered in lower doses, it can elicit feelings of euphoria and heightened sexual arousal, while higher doses can lead to unconsciousness.