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 February 13, 2033. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases 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:	267
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

Constraining patent/regulatory exclusivity:

TREATMENT OF CATAPLEXY IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY

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.

Pharmacology for WAKIX

Drug Class	Histamine-3 Receptor Antagonist/Inverse Agonist
Mechanism of Action	Cytochrome P450 3A4 Inducers Histamine H3 Receptor Antagonists Histamine H3 Receptor Inverse Agonists

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 five FDA Regulatory Exclusivities.

This potential generic entry date is based on TREATMENT OF CATAPLEXY IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY.

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

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	8,354,430
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	211150-002	Aug 14, 2019		RX	Yes	Yes	8,354,430
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

Expired US Patents for WAKIX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	7,169,928
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	7,169,928
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	7,910,605
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	8,354,430
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-002	Aug 14, 2019	8,354,430
Harmony	WAKIX	pitolisant hydrochloride	TABLET;ORAL	211150-001	Aug 14, 2019	7,910,605

International Patents for WAKIX

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

Country	Patent Number	Title	Estimated Expiration
Austria	276751
Austria	326446
Australia	5511999
Belgium	2016C048
Canada	2321881	ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES (NON-IMIDAZOLE ALKYLAMINES AS HISTAMINE H3-RECEPTOR LIGANDS AND THEIR THERAPEUTIC APPLICATIONS)
Germany	69920472

Supplementary Protection Certificates for WAKIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1428820	300832	Netherlands		PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820	122016000073	Germany		PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
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	CA 2016 00042	Denmark		PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
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	499	Finland

DrugChatter Q&A for WAKIX

Wakix product withdrawn uk?
Wakix uk withdrawn 17 dec 2024?
How many more years does wakix have on their patten?
Wakix cost without insurance?
Why is wakix so expensive?