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7 April 2017Americas

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.

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More on this story

Americas
17 July 2018   The US Court of Appeals for the Federal Circuit has rejected Jazz Pharmaceuticals’ attempt to revive patents covering its narcolepsy drug Xyrem.
Generics
6 January 2022   Hikma Pharmaceuticals has secured a win in its “skinny label” patent suit with Amarin Pharmaceuticals, following a ruling handed down by a federal court in the state of Delaware.

More on this story

Americas
17 July 2018   The US Court of Appeals for the Federal Circuit has rejected Jazz Pharmaceuticals’ attempt to revive patents covering its narcolepsy drug Xyrem.
Generics
6 January 2022   Hikma Pharmaceuticals has secured a win in its “skinny label” patent suit with Amarin Pharmaceuticals, following a ruling handed down by a federal court in the state of Delaware.

More on this story

Americas
17 July 2018   The US Court of Appeals for the Federal Circuit has rejected Jazz Pharmaceuticals’ attempt to revive patents covering its narcolepsy drug Xyrem.
Generics
6 January 2022   Hikma Pharmaceuticals has secured a win in its “skinny label” patent suit with Amarin Pharmaceuticals, following a ruling handed down by a federal court in the state of Delaware.