Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: sodium oxybate
Trade Name: Xyrem
Date Designated: 11/07/1994
Orphan Designation: Treatment of narcolepsy.
Orphan Designation Status: Designated/Approved
Jazz Pharmaceuticals Ireland Limited
5th Floor Waterloo Exchange
Waterloo Road
Dublin 4 D04 E5W7
Ireland

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: sodium oxybate
Trade Name: Xyrem
Marketing Approval Date: 07/17/2002
Approved Labeled Indication: Treatment of cataplexy associated with narcolepsy
Exclusivity End Date: 07/17/2009 
Exclusivity Protected Indication* :  
2 Generic Name: sodium oxybate
Trade Name: Xyrem
Marketing Approval Date: 11/18/2005
Approved Labeled Indication: Treatment of excessive daytime sleepiness in patients with narcolepsy
Exclusivity End Date: 11/18/2012 
Exclusivity Protected Indication* :  
3 Generic Name: sodium oxybate
Trade Name: Xyrem
Marketing Approval Date: 10/26/2018
Approved Labeled Indication: Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Exclusivity End Date: 10/26/2025 
Exclusivity Protected Indication* :  Xyrem is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in pediatric patients 7 years of age and older with narcolepsy.
4 Generic Name: calcium, magnesium, potassium, and sodium oxybates
Trade Name: Xywav
Marketing Approval Date: 07/21/2020
Approved Labeled Indication: XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
Exclusivity End Date: 07/21/2027 
Exclusivity Protected Indication* :  XYWAV is indicated for the treatment of cataplexy or excessive daytime sleepiness (EDS) in patients 7 years of age and older with narcolepsy.
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-