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Last Updated: July 18, 2024

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WAKIX Drug Patent Profile


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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 have been three 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

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Drug patent expirations by year for WAKIX
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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WAKIX
Generic Entry Date for WAKIX*:
Constraining patent/regulatory exclusivity:
NDA:
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.

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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of WAKIX is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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

Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY

Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY

Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H.sub.3-receptor ligands
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY

Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H.sub.3-receptor ligands
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY

FDA Regulatory Exclusivity protecting WAKIX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY
Exclusivity Expiration: ⤷  Sign Up

TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY
Exclusivity Expiration: ⤷  Sign Up

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

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

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

Patent: 4734
Patent: COMPUESTO QUE COMPRENDE MONOCLORHIDRATO DE 1-[3-[3(4-CLOROFENIL) PROPOXI] PROPIL] - PIPERIDINA CRISTALINO, PROCEDIMIENTO PARA SU FABRICACION Y COMPOSICIONES FARMACEUTICAS.
Estimated Expiration: ⤷  Sign Up

Austria

Patent: 91716
Estimated Expiration: ⤷  Sign Up

Patent: 02154
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 97016
Patent: SEL DE MONOHYDROCHLORURE DE 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
Estimated Expiration: ⤷  Sign Up

China

Patent: 1155793
Patent: Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0080446
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 08428
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 46384
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 90858
Patent: Sel de monohydrochloride de 1-[3-[3-(4-chlorophenyl)propoxy[propyl]-piperidine (Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine)
Estimated Expiration: ⤷  Sign Up

Patent: 46384
Patent: SEL DE MONOHYDROCHLORIDE DE 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE (MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE)
Estimated Expiration: ⤷  Sign Up

Germany

Patent: 2005005941
Estimated Expiration: ⤷  Sign Up

Patent: 2006001938
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 72604
Estimated Expiration: ⤷  Sign Up

Patent: 08530050
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 07009574
Patent: SAL DE MONOCLORHIDRATO DE 1-[3-[3-(4-CLOROFENIL)PROPOXI]-PROPIL]- PIPERIDINA. (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE.)
Estimated Expiration: ⤷  Sign Up

Montenegro

Patent: 103
Patent: MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 46384
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 46384
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 624
Patent: MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE)
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 46384
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1344271
Estimated Expiration: ⤷  Sign Up

Patent: 070101381
Patent: MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 09948
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 93711
Estimated Expiration: ⤷  Sign Up

Patent: 0639157
Patent: New salt of 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 369
Patent: NUEVA SAL DE 1-(-3-(3-(4-CLOROFENIL) PROPOXI(PROPIL) -PIPERIDINA
Estimated Expiration: ⤷  Sign Up

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
European Patent Office 1846384 SEL DE MONOHYDROCHLORIDE DE 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE (MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE) ⤷  Sign Up
Slovenia 1863487 ⤷  Sign Up
Portugal 1428820 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for WAKIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 SPC/GB16/052 United Kingdom ⤷  Sign Up PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404
1428820 CA 2016 00042 Denmark ⤷  Sign Up PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820 2016/038 Ireland ⤷  Sign Up PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.