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Jazz settles with Amneal over generic version of blockbuster sleep disorder drug

Jazz Pharmaceuticals PLC has reached a settlement with Amneal Pharmaceuticals Inc. over the sale of a generic version of the former's blockbuster drug Xyrem.

Xyrem, also known as sodium oxybate, is the only drug approved in the U.S. to treat cataplexy, a loss of muscle strength, and narcolepsy, a sleep disorder characterized by excessive sleepiness.

Under the settlement, Amneal received a nonexclusive right to sell a limited quantity of an authorized copy of Xyrem from July 1, 2023 — or earlier, under certain circumstances — to Dec. 31, 2025. The Bridgewater, N.J.-based company was also granted a nonexclusive license to sell its generic starting Dec. 31, 2025, or earlier under certain circumstances.

The settlement comes after a U.S. appeals court in July invalidated several of Jazz Pharmaceuticals' patents related to Xyrem.

Under the terms of the settlement, Dublin-based Jazz Pharmaceuticals will receive royalties on the sales of the generic version and other payments. Jazz Pharmaceuticals said the settlement resolves patent litigation with all nine companies seeking to market a Xyrem generic.

Xyrem generated revenues of $1.19 billion for Jazz Pharmaceuticals in 2017.