Last Updated: October 6, 2026

Details for New Drug Application (NDA): 211150

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NDA 211150 describes WAKIX, which is a drug marketed by Harmony and is included in one NDA. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the WAKIX profile page.

The generic ingredient in WAKIX is pitolisant hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.

Summary for 211150

Tradename:	WAKIX
Applicant:	Harmony
Ingredient:	pitolisant hydrochloride
Patents:	3

Pharmacology for NDA: 211150

Mechanism of Action	Cytochrome P450 3A4 Inducers Histamine H3 Receptor Antagonists Histamine H3 Receptor Inverse Agonists

Suppliers and Packaging for NDA: 211150

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-045	72028-045-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-045-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150	NDA	Harmony Biosciences, LLC	72028-178	72028-178-03	1 BOTTLE, PLASTIC in 1 CARTON (72028-178-03) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 4.45MG BASE
Approval Date:	Aug 14, 2019	TE:	AB	RLD:	Yes
Regulatory Exclusivity Expiration:	Aug 14, 2026
Regulatory Exclusivity Use:	INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY
Regulatory Exclusivity Expiration:	Jun 21, 2027
Regulatory Exclusivity Use:	NEW PATIENT POPULATION
Regulatory Exclusivity Expiration:	Oct 13, 2027
Regulatory Exclusivity Use:	TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY

Expired US Patents for NDA 211150

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	⤷ Start Trial	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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