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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 Management, Inc.
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
3 Generic Name: pitolisant
Trade Name: Wakix
Marketing Approval Date: 06/21/2024
Approved Labeled Indication: treatment of excessive daytime sleepiness (EDS) or cataplexy in adult patients with narcolepsy and treatment of EDS in pediatric patients 6 years of age and older with narcolepsy
Exclusivity End Date: 06/21/2031 
Exclusivity Protected Indication* :  treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy
4 Generic Name: pitolisant
Trade Name: Wakix
Marketing Approval Date: 02/13/2026
Approved Labeled Indication: treatment of excessive daytime sleepiness (EDS) or cataplexy in patients 6 years of age and older with narcolepsy
Exclusivity End Date: 02/13/2033 
Exclusivity Protected Indication* :  treatment of cataplexy in pediatric patients 6 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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