Hikma enters settlement agreement with Jazz to sell Xyrem generic
Hikma Pharmaceuticals has entered into a settlement agreement with Jazz Pharmaceuticals, following a patent infringement dispute related to Jazz’s drug Xyrem (sodium oxybate).
Xyrem is a treatment for cataplexy, a sudden loss of muscle strength. It also reduces daytime sleepiness in patients with narcolepsy.
Under the settlement agreement, Hikma and its subsidiary West-Ward Pharmaceuticals will be given the right to sell a g eneric of Xyrem, beginning in January 2023.
The initial term of the agreement is six months, with the option of extending it up to five years.
Jazz sued West-Ward last year at the US District Court for the District of New Jersey, after West-Ward had filed an Abbreviated New Drug Application with the Food and Drug Administration.
According to a statement released on Wednesday, April 5, Hikma will pay Jazz a royalty on net sales of the generic product, but will “initially retain a meaningful percentage of net sales”.
Mike Raya, CEO of West-Ward, said: “We are very pleased to have reached an agreement with Jazz with terms that are favourable for both parties.”
He added: “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.”
In its 2016 annual report, Jazz revealed that net sales of Xyrem were approximately $1.1 million that year.