Jazz Pharmaceuticals plc, an international biopharmaceutical company, announced that certain of its subsidiaries have entered into agreements with Hikma Pharmaceuticals PLC and related entities (Hikma) resolving patent litigation related to Xyrem (sodium oxybate) oral solution.
The litigation, which has been pending in the US District Court for the District of New Jersey since 2010, resulted from the submission by Roxane Laboratories, Inc. (which was subsequently acquired by Hikma) of an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) seeking approval to market a generic version of Xyrem.
In connection with the settlement, Jazz has granted Hikma and its wholly owned subsidiary, West-Ward Pharmaceuticals Corp. (West-Ward), the right to sell an authorized generic (AG) version of Xyrem in the US under the Xyrem New Drug Application (NDA), commencing on January 1, 2023, or earlier under certain circumstances customary for settlement agreements of this nature. The AG product will be marketed through the Xyrem Risk Evaluation and Mitigation Strategy (REMS) programme. The initial term of the AG arrangement is six months, and Hikma has the option to continue the sale of the AG product for up to a total of five years. Jazz will receive a meaningful royalty on net sales of the AG product, with the royalty rate increasing during the initial AG term based on increased AG sales. There will be a substantial increase in the royalty rate should the AG term be extended beyond one year. Jazz will also be paid for supply of the AG product and will be reimbursed for a portion of the service costs associated with the operation of the Xyrem REMS and distribution of the AG. Specific financial and other terms related to the AG product are confidential. Hikma has been granted a license to sell its generic sodium oxybate product under its ANDA at the end of the AG term.
"This settlement arrangement provides additional clarity related to our Xyrem intellectual property as we continue our strategy to expand and diversify our product portfolio and R&D pipeline, in line with our goal of delivering new clinically meaningful therapeutic options for patients," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals. "We are pleased that this settlement positions us to facilitate the safe distribution of West-Ward's AG of Xyrem through the Xyrem REMS."
As required by law, Jazz Pharmaceuticals and Hikma will submit the settlement agreement to the US Federal Trade Commission (FTC) and the US Department of Justice (DOJ) for review.
Similar patent litigation brought by Jazz Pharmaceuticals against four other companies that have filed ANDAs with the FDA seeking approval to market a generic version of Xyrem remains pending in the US District Court for the District of New Jersey.
Xyrem (sodium oxybate) oral solution, CIII, is indicated for the treatment of cataplexy in narcolepsy and for the treatment of excessive daytime sleepiness (EDS) in narcolepsy. Xyrem may only be dispensed to patients enrolled in the Xyrem REMS Programme. Xyrem was first approved in the US in 2002.
Jazz Pharmaceuticals plc is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs.
Jazz pharma, xyrem patent litigation, hikma pharma
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