Hikma, Jazz reach settlement over sodium oxybate product
LONDON, UK: Hikma Pharmaceuticals PLC (Hikma) has entered into a settlement agreement with Jazz Pharmaceuticals plc (Jazz), 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 wholly owned subsidiary, West-Ward Pharmaceuticals Corp (West-Ward), the right to sell an authorised generic (AG) of Xyrem in the US market commencing on 1 January 2023.
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 and Hikma has the option to extend the AG term for up to a total of five years. Jazz has also granted Hikma a license to market generic sodium oxybate pursuant to its ANDA at the end of the AG term.
Hikma will pay Jazz a royalty on net sales of the AG product, but will initially retain a meaningful percentage of net sales. Hikma will also pay for the supply of the AG product and will reimburse Jazz for a portion of the service costs associated with the operation of the Xyrem REMS and distribution of the AG. The royalty rate paid to Jazz will increase should the AG term be extended beyond one year.
Hikma, through its wholly owned US subsidiary, Roxane Laboratories Inc was the first ANDA applicant to submit a substantially complete ANDA with Paragraph IV certification for sodium oxybate oral solution, 500 mg/mL and therefore is eligible for 180 days of generic drug exclusivity.
“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,” said Mike Raya, CEO of West-Ward.
Important safety information
Sodium oxybate is a central nervous system (CNS) depressant and has caused changes in alertness (or consciousness) and trouble breathing (respiratory depression).
Sodium oxybate is a form of gamma-hydroxybutyrate (GHB). Abuse of GHB, either alone or in combination with other drugs that cause changes in alertness (or consciousness), has caused serious side effects. These effects include seizures, trouble breathing (respiratory depression), very low levels of alertness (consciousness), coma, and death.
Sodium oxybate can cause serious side effects, including the following:
Breathing problems, including slower breathing, trouble breathing, and or/short periods of not breathing while sleeping (sleep apnea). People who already have breathing or lung problems have a higher chance of having breathing problems when they use sodium oxybate.
Mental health problems, including confusion, seeing or hearing things that are not real (hallucinations), unusual or disturbing thoughts (abnormal thinking), feeling anxious or upset, depression, or thoughts of killing yourself or trying to kill yourself. Call your doctor right away if you have symptoms of mental health problems.
