NDAORALSOLUTIONPriority Review
Approved
Jul 2020
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
4
Clinical Trials (4)
A Study to Investigate the Effect of XYWAV on Sleepiness, Polysomnography, and Functional Outcomes in Participants With Idiopathic Hypersomnia or Narcolepsy
Started Jul 2023
207 enrolled
Idiopathic HypersomniaNarcolepsy
A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy
Started Jun 2023
160 enrolled
Narcolepsy
A Patient-Centric, Prospective, Observational, Non-Interventional Switch Study of XYWAV in Narcolepsy
Started Apr 2021
110 enrolled
Narcolepsy
An Interventional Safety Switch Study (Segue Study) of XYWAV in Narcolepsy
Started Mar 2021
62 enrolled
Narcolepsy
Loss of Exclusivity
LOE Date
Feb 22, 2041
182 months away
Patent Expiry
Feb 22, 2041
Exclusivity Expiry
Aug 12, 2028