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Last Updated: May 24, 2022

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.

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

The generic ingredient in WAKIX is pitolisant hydrochloride. Additional details are available on the pitolisant hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Wakix

Wakix will be eligible for patent challenges on August 14, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 25, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for WAKIX
International Patents:61
US Patents:3
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 55
Patent Applications: 126
Drug Prices: Drug price information for WAKIX
What excipients (inactive ingredients) are in WAKIX?WAKIX excipients list
DailyMed Link:WAKIX at DailyMed
Drug patent expirations by year for WAKIX
Drug Prices for WAKIX

See drug prices for WAKIX

DrugPatentWatch® Estimated Generic Entry Opportunity 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.

US Patents and Regulatory Information for WAKIX

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of WAKIX is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

FDA Regulatory Exclusivity protecting WAKIX

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN ADULT PATIENTS WITH NARCOLEPSY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF CATAPLEXY IN ADULT PATIENTS WITH NACROLEPSY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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 211150-001 Aug 14, 2019 See Plans and Pricing See Plans and Pricing
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 See Plans and Pricing See Plans and Pricing
>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
Estimated Expiration: See Plans and Pricing

Austria

Patent: 1716
Estimated Expiration: See Plans and Pricing

Patent: 2154
Estimated Expiration: See Plans and Pricing

Canada

Patent: 97016
Estimated Expiration: See Plans and Pricing

China

Patent: 1155793
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0080446
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 08428
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46384
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 90858
Estimated Expiration: See Plans and Pricing

Patent: 46384
Estimated Expiration: See Plans and Pricing

Germany

Patent: 2005005941
Estimated Expiration: See Plans and Pricing

Patent: 2006001938
Estimated Expiration: See Plans and Pricing

Japan

Patent: 72604
Estimated Expiration: See Plans and Pricing

Patent: 08530050
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 07009574
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 103
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46384
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46384
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 624
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46384
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1344271
Estimated Expiration: See Plans and Pricing

Patent: 070101381
Estimated Expiration: See Plans and Pricing

Spain

Patent: 09948
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 93711
Estimated Expiration: See Plans and Pricing

Patent: 0639157
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 369
Estimated Expiration: See Plans and Pricing

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
Spain 2260703 See Plans and Pricing
European Patent Office 1863487 UTILISATION DES ALKYLAMINES SANS IMIDAZOLES COMME LIGANDES DU RECEPTEUR HISTAMINE H3 POUR LE TRAITEMENT DES SYMPTÔMES DE LA MALADIE DE PARKINSON (TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) See Plans and Pricing
Singapore 147415 TREATMENT OF PARKINSONÆS DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS See Plans and Pricing
Portugal 1846384 See Plans and Pricing
Austria 391716 See Plans and Pricing
Germany 602006001938 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for WAKIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 16C0038 France See Plans and Pricing PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 499 Finland See Plans and Pricing
1428820 2016/038 Ireland See Plans and Pricing PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 1690039-1 Sweden See Plans and Pricing PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404
1428820 40/2016 Austria See Plans and Pricing PRODUCT NAME: PITOLISANT UND SEINE PHARMAZEUTISCH VERTRAEGLICHEN SALZE EINSCHLIESSLICH DEM HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 (MITTEILUNG) 20160404
1428820 122016000073 Germany See Plans and Pricing PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Express Scripts
Harvard Business School
McKesson
Boehringer Ingelheim
Johnson and Johnson

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.