• 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: Solriamfetol
Trade Name: Sunosi
Date Designated: 08/20/2012
Orphan Designation: Treatment of narcolepsy
Orphan Designation Status: Designated/Approved
Axsome Malta, Ltd.
78 Mill Street, Zone 5, Central Business District
Qormi CBD 5090
Malta

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

Marketing approved:

1 Generic Name: Solriamfetol
Trade Name: Sunosi
Marketing Approval Date: 06/17/2019
Approved Labeled Indication: SUNOSI is indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy
Exclusivity End Date: 06/17/2026 
Exclusivity Protected Indication* :  To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-