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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: Pitolisant
Trade Name: WAKIX
Date Designated: 05/17/2010
Orphan Designation: Treatment of narcolepsy
Orphan Designation Status: Designated/Approved
Harmony Biosciences, LLC
630 W Germantown Pike
Suite 215
Plymouth Meeting, Pennsylvania 19462
United States

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

Marketing approved:

1 Generic Name: Pitolisant
Trade Name: WAKIX
Marketing Approval Date: 08/14/2019
Approved Labeled Indication: WAKIX is indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy
Exclusivity End Date: 08/14/2026 
Exclusivity Protected Indication* :  For the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy
2 Generic Name: pitolisant
Trade Name: WAKIX®
Marketing Approval Date: 10/13/2020
Approved Labeled Indication: treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy
Exclusivity End Date: 10/13/2027 
Exclusivity Protected Indication* :  treatment of cataplexy in adult patients with narcolepsy

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