Jazz sues Avadel over Xyrem patent

Jazz Pharmaceuticals has claimed that Avadel Pharmaceuticals’ proposed narcolepsy drug infringes a patent related to Jazz’s blockbuster treatment Xyrem (sodium oxybate).

Jazz has asked the US District Court for the District of Delaware to issue a preliminary injunction enjoining Avadel from marketing or selling its proposed drug—code-named FT218.

The Xyrem patent—US Patent 11,147,782—covers “GHB formulation and method for its manufacture” and was issued on October 19, 2021.

Avadel filed a New Drug Application (NDA) with the US Food and Drug Administration (FDA), seeking approval to manufacture and sell a sodium oxybate product. It formally announced the submission on February 26, 2021.

“Avadel, by the submission of its NDA to the FDA, has indicated that it seeks approval to engage in the commercial manufacture, use, offer for sale, sale, and/or importation into the US of Avadel’s Proposed Product, prior to the expiration of the ’782 patent,” Jazz claimed in the complaint.

Jazz has also requested a judgment awarding damages if Avadel markets or sells the treatment while the lawsuit proceeds.

Prior litigation

This is not the first lawsuit Jazz has filed against Avadel claiming infringement of Xyrem.

In May this year, Jazz accused Avadel of infringing five patents related to the narcolepsy drug in a complaint filed in the Delaware federal court.

Jazz also sued Avadel at the same court in April, citing infringement of another Xyrem patent—US 11,077,079.

In an earnings call in May, Avadel said that it planned to accelerate the launch of FT218, reported Reuters.

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