Jazz Pharmaceuticals said certain of its subsidiaries entered into agreements with Hikma Pharmaceuticals and related entities resolving patent litigation related to Xyrem oral solution.
Xyrem is a drug for patients with narcolepsy, a kind of sleeping disorder.
The litigation resulted from a submission by Roxane Laboratories — 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 said it has granted Hikma and its wholly owned subsidiary, West-Ward Pharmaceuticals, the right to sell an authorized generic (AG) version of Xyrem in the US under the Xyrem New Drug Application (NDA), commencing January 1, 2023, or earlier under certain circumstances.
“The AG product will be marketed through the Xyrem Risk Evaluation and Mitigation Strategy (REMS) program,” said Jazz.
“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.”
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.