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WAKIX Drug Patent Profile

When do Wakix patents expire, and what generic alternatives are available?

Wakix is a drug marketed by Harmony and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-one patent family members in thirty-one countries.

The generic ingredient in WAKIX is pitolisant hydrochloride. One supplier is listed for this compound. Additional details are available on the pitolisant hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Wakix

Wakix was eligible for patent challenges on August 14, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 7, 2030. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for WAKIX

International Patents:	61
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	64
Patent Applications:	113
Drug Prices:	Drug price information for WAKIX
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for WAKIX
What excipients (inactive ingredients) are in WAKIX?	WAKIX excipients list
DailyMed Link:	WAKIX at DailyMed

See drug prices for WAKIX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for WAKIX

NDA:

211150

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Anatomical Therapeutic Chemical (ATC) Classes for WAKIX

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for WAKIX

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WAKIX	Tablets	pitolisant hydrochloride	4.45 mg and 17.8 mg	211150	7	2023-08-14

US Patents and Regulatory Information for WAKIX

WAKIX is protected by five US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting WAKIX

FDA Regulatory Exclusivity protecting WAKIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019		RX	Yes	Yes
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019		RX	Yes	Yes
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019		RX	Yes	No

Expired US Patents for WAKIX

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

International Patents for WAKIX

When does loss-of-exclusivity occur for WAKIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Austria

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Germany

Japan

Mexico

Montenegro

Poland

Portugal

Serbia

Slovenia

South Korea

Spain

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering WAKIX around the world.

Country	Patent Number	Title	Estimated Expiration
South Africa	200708086	Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands
Denmark	1100503
Japan	2016106142	非イミダゾールアルキルアミンヒスタミンＨ３−受容体リガンドによるパーキンソン病、閉塞性睡眠時無呼吸、レビー小体型認知症、血管性認知症の治療 (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS)
Serbia	52911	LEČENJE SIMPTOMA PARKINSONOVE BOLESTI SA ALKILAMIN HISTAMINOM BEZ IMIDAZOLA - X3 - RECEPTORA LIGANDA (TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS)
Serbia	50624	MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
Canada	2603656	TRAITEMENT DE LA MALADIE DE PARKINSON, DE L'APNEE OBSTRUCTIVE DU SOMMEIL, DE LA DEMENCE AVEC CORPS DE LEWY, DE LA DEMENCE VASCULAIRE, AVEC DES LIGANDS DU RECEPTEUR H3 D'HISTAMINE A ALKYLAMINES NON IMIDAZOLES (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS)
Portugal	1428820

Supplementary Protection Certificates for WAKIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1428820	2016/038	Ireland		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820	CR 2016 00042	Denmark		PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820	2016C/048	Belgium		PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404
1428820	300832	Netherlands		PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820	93229	Luxembourg		PRODUCT NAME: ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H-3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES, FIRST REGISTRATION DATE: 20160404
1428820	SPC/GB16/052	United Kingdom		PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404
1428820	CA 2016 00042	Denmark		PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404