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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
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
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.
 
Generic Name:  pitolisant
Trade Name:  WAKIX®
Date Designated:  05/17/2010
Orphan Designation:  Treatment of narcolepsy
Orphan Designation Status:  Designated/Approved
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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