Jazz Pharmaceuticals plc announced that certain of its subsidiaries have entered into agreements with Hikma Pharmaceuticals PLC and related entities resolving patent litigation related to Xyrem (sodium oxybate) oral solution. The litigation, which has been pending in the U.S. 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 U.S. Food and Drug Administration (FDA) seeking approval to market a generic version of Xyrem.
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.
In connection with the settlement, Jazz has granted Hikma and its wholly owned subsidiary, West-Ward Pharmaceuticals Corp, the right to sell an authorized generic version of Xyrem in the United States 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 authorized generic product will be marketed through the Xyrem Risk Evaluation and Mitigation Strategy (REMS) program. The initial term of the authorized generic arrangement is six months, and Hikma has the option to continue the sale of the authorized generic product for up to a total of five years.
Jazz will receive a meaningful royalty on net sales of the authorized generic product, with the royalty rate increasing during the initial authorized generic term based on increased authorized generic sales. There will be a substantial increase in the royalty rate should the authorized generic term be extended beyond one year. Jazz will also be paid for supply of the authorized generic product and will be reimbursed for a portion of the service costs associated with the operation of the Xyrem REMS and distribution of the authorized generic. Specific financial and other terms related to the authorized generic product are confidential. Hikma has been granted a license to sell its generic sodium oxybate product under its ANDA at the end of the authorized generic 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,” says Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals, in a release. “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 U.S. Federal Trade Commission and the U.S. Department of Justice 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 U.S. District Court for the District of New Jersey.
For additional information related to the settlement between Jazz Pharmaceuticals and Hikma, please refer to the Current Report on Form 8-K to be filed by Jazz Pharmaceuticals with the Securities and Exchange Commission.