Hikma signs settlement agreement over Jazz’s Xyrem patent litigation

Hikma Pharmaceuticals has entered a settlement agreement that resolves patent litigation related to Jazz Pharmaceuticals’ Xyrem (sodium oxybate) oral solution at 500mg/ml per product.

Under the agreement, Hikma and its wholly owned subsidiary West-Ward Pharmaceuticals will acquire the rights from Jazz to sell an authorised generic (AG) of Xyrem in the US market, beginning 1 January 2023 or earlier. 

West-Ward Pharmaceuticals CEO Mike Raya said: "We are very pleased to have reached an agreement with Jazz with terms that are favourable for both parties. 

"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."

A form of gamma hydroxybutyrate (GHB), Sodium oxybate is a central nervous system (CNS) depressant and causes changes in alertness and trouble breathing. 

The product will be marketed through the Xyrem Risk Evaluation and Mitigation Strategy (REMS) programme. 

The six months AG agreement has an option to be extended for up to a total of five years. 

Hikma also obtained a licence to market generic sodium oxybate, pursuant to its ANDA at the end of the AG term.

The company will pay a royalty to Jazz on net sales of the AG product, as well as for its supply.

It will reimburse Jazz for a portion of the service costs associated with the operation of the Xyrem REMS and distribution of the AG. 

Through its wholly owned US subsidiary Roxane Laboratories, Hikma submitted the first ANDA with Paragraph IV certification for sodium oxybate oral solution.