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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	Pitolisant
Trade Name:	WAKIX
Date Designated:	05/17/2010
Orphan Designation:	Treatment of narcolepsy
Orphan Designation Status:	Designated/Approved
Sponsor:	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.

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

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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