Hikma, Jazz settle for Xyrem patent litigation

Hikma Pharmaceuticals and Jazz Pharmaceuticals have found a mutual language regarding a Jazz’s Xyrem patent litigation.

Xyrem is a sodium oxybate oral solution, 500mg/mL product, for which Jazz will grant Hikma and its subsidiary West-Ward Pharmaceuticals Corp. the right to sell an authorised generic (AG) of Xyrem in America from 2023. Should it need to be said, under certain circumstances.

According to Hikma’s press release issued Wednesday, 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 extend the AG term for up to a total of five years, says the press release. Furthermore, Jazz has also granted Hikma a licence to market generic sodium oxybate pursuant to its ANDA at the end of the AG term.

As the deal goes, Hikma will pay Jazz a royalty on net sales of the AG product, but will initially retain a certain percentage of net sales. Hikma said the percentage will be “meaningful”, and that there will be some more payments and terms.

Noteworthy, Jazz reported net sales of Xyrem of about $1,108 million in 2016.

Also, Hikma said it was the first ANDA applicant to submit a substantially complete ANDA for sodium oxybate oral solution, 500 mg/mL and therefore is eligible for 180 days of generic drug exclusivity. This ANDA was complete through a subsidiary from US, Roxane Laboratories, Inc.

Mike Raya, CEO of West-Ward said that both parties have reached a deal favourable for both. “Sodium oxybate is an exciting product in our pipeline and supports our strategy of developing a differentiated product portfolio to drive sustainable growth for our US business,” concluded Raya.