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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: calcium, magnesium, potassium, and sodium oxybates
Trade Name: Xywav
Date Designated: 07/31/2019
Orphan Designation: Treatment of idiopathic hypersomnia
Orphan Designation Status: Designated/Approved
Jazz Pharmaceuticals Ireland Limited
5th Floor Waterloo Exchange
Waterloo Road
Dublin
Ireland

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

Marketing approved:

1 Generic Name: calcium, magnesium, potassium, and sodium oxybates
Trade Name: Xywav
Marketing Approval Date: 08/12/2021
Approved Labeled Indication: Treatment of idiopathic hypersomnia (IH) in adults
Exclusivity End Date: 08/12/2028 
Exclusivity Protected Indication* :  Treatment of idiopathic hypersomnia (IH) in adults
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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