Jazz settled patent dispute with Amneal Pharmaceuticals
On October 11, Jazz Pharmaceuticals settled ongoing patent litigation against Amneal Pharmaceuticals related to Amneal's abbreviated new drug application,ANDA, seeking to market a generic version of Xyrem oral solution. In connection with the settlement, Amneal will have a non-exclusive right to sell a limited volume of an authorized generic version of Xyremfor a term beginning on July 1, 2023, or earlier under certain circumstances, and ending on December 31, 2025. Jazz is entitled to receive a meaningful royalty on net sales of the Amneal AG Product as well as payment for the supply of the Amneal AG Product and reimbursement for a portion of the services costs associated with distribution of the Amneal AG Product through the Xyrem Risk Evaluation and Mitigation Strategy. In addition, Jazz granted Amneal a non-exclusive license to make, have made and market its own generic sodium oxybate product under Amneal's ANDA effective December 31, 2025, or earlier under certain circumstances. The settlement with Amneal represents settlement of all patent infringement litigation against the nine companies that have sent Jazz notices that they had filed ANDAs requesting approval to market a generic version of Xyrem. It is possible that additional companies may file ANDAs seeking to market a generic version of Xyrem or new drug applications referencing Xyrem.