Jazz gets orphan drug exclusivity for sleep disorder therapy

 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Exclusivity (ODE) for Xywav® (calcium, magnesium, potassium, and sodium oxybates) oral solution, for the treatment of idiopathic hypersomnia in adults, making it the second ODE for the medication following the exclusivity granted in the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.

As Jazz was the first sponsor to obtain FDA approval for idiopathic hypersomnia, Xywav will have seven-year market exclusivity for this indication from its FDA approval on August 12, 2021. The FDA's Orphan Drug Designation program is designed to advance the development of drugs that treat a condition affecting 200,000 or fewer U.S. patients annually.

https://finance.yahoo.com/news/u-fda-grants-orphan-drug-211000548.html