Hikma Pharmaceuticals has entered into a settlement agreement with Jazz Pharmaceuticals that resolves patent litigation related to Jazz’s Xyrem (sodium oxybate) oral solution, 500mg/mL product.
Under the settlement agreement, Jazz will grant Hikma and its subsidiary, West-Ward Pharmaceuticals, the right to sell an authorised generic (AG) of Xyrem in the US market.
The AG product will be marketed through the XYREM(R) Risk Evaluation and Mitigation Strategy (REMS) programme.
The initial term of the AG arrangement is six months. Hikma has the option to extend the AG term for up to a total of five years. Jazz has also granted Hikma a licence to market generic sodium oxybate pursuant to its abbreviated new drug application (ANDA) at the end of the AG term.
Hikma will pay for the supply of the AG product and reimburse Jazz for a portion of the service costs associated with the operation of the Xyrem REMS and distribution of the AG.
Through its US subsidiary, Roxane Laboratories, Hikma was the first applicant to submit a substantially complete ANDA with Paragraph IV certification for sodium oxybate oral solution, 500 mg/mL. It is therefore is eligible for 180 days of generic drug exclusivity.
