A U.S. appeals court ordered Jazz Pharmaceuticals Inc (JAZZP.UL) on Friday to de-list a patent related to its blockbuster narcolepsy drug Xyrem from the U.S. Food and Drug Administration's register of approved medications, in a win for rival drugmaker Avadel CNS Pharmaceuticals Inc.
The Federal Circuit said the inclusion of the patent was preventing the FDA from approving Lumryz until June 2023.
Avadel CEO Greg Divis said the company was pleased with the decision and looks forward to "bringing Lumryz to the narcolepsy community, who have been deprived of a treatment option that could dramatically improve their quality of life."Avadel said in a U.S. Securities and Exchange Commission filing on Friday that it intends to seek final FDA approval for Lumryz after Jazz complies with the order.
The patent at the center of the case covers aspects of Jazz's distribution system, which controls access to narcolepsy drugs with a central pharmacy and computer database. It relates to a risk-mitigation strategy that the FDA required before approving Xyrem, whose active ingredient GHB can be misused as a date-rape drug.Avadel for infringing the patent and others in Delaware federal court in 2021, in a lawsuit that is still ongoing.
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