Jazz Pharmaceuticals plc. (Nasdaq: JAZZ) today announced that a new patent related to Xyrem® (sodium oxybate) oral solution titled "Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy" will issue today. The new patent, number 8,262,650, will be submitted for listing in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book).
In addition to the new patent, nine other U.S. patents have been issued related to Xyrem's stable and microbially resistant formulation, its manufacturing process and its method of use, including its restricted distribution system. The new patent, which will expire in December 2019, will be the eighth patent referencing Xyrem to be listed in the Orange Book. The listed patents expire at various times from 2019 to 2024.
"Continually enhancing the patient and provider experience with Xyrem is an important strategic priority for our company, and our intellectual property related to Xyrem has been integral to ensuring the safe and effective use of sodium oxybate for the past 10 years," said Bruce Cozadd, chairman and chief executive officer of Jazz Pharmaceuticals.
Xyrem (sodium oxybate) oral solution is the only product approved by the United States Food and Drug Administration for the treatment of both cataplexy and excessive daytime sleepiness in patients with narcolepsy.