Dec. 4, 2012
/PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the United States Patent and Trademark Office has issued a patent related to the use of Xyrem® (sodium oxybate) oral solution for the treatment of narcolepsy, titled "Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy." The new patent, number 8,324,275, will be submitted for listing in the FDA's Approved Drug Products With Therapeutic Equivalence Evaluations (the Orange Book).
"Our intellectual property, including the patent issued today, reflects the company's continued commitment to the further understanding of Xyrem and to supporting its safe and effective use," stated
, chairman and chief executive officer of Jazz Pharmaceuticals.
In addition to the newly issued patent, ten other U.S. patents have previously 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
, would be the ninth patent referencing Xyrem to be listed in the Orange Book. The listed patents expire at various times from 2019 to 2024.
Xyrem 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.
About Jazz Pharmaceuticals
Jazz Pharmaceuticals plc is a specialty biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing innovative products that address unmet medical needs. The company has a diverse portfolio of products in the areas of narcolepsy, oncology, pain and psychiatry. The company's U.S. marketed products in these areas include: Xyrem® (sodium oxybate) oral solution, Erwinaze® (asparaginase Erwinia chrysanthemi), Prialt® (ziconotide) intrathecal infusion, Luvox CR® (fluvoxamine maleate), FazaClo® (clozapine, USP) HD and FazaClo LD. Outside of the U.S., Jazz Pharmaceuticals also has a number of products marketed by its international division, EUSA Pharma.