WAKIX Drug Patent Profile
✉ Email this page to a colleague
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
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 |


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.
Anatomical Therapeutic Chemical (ATC) Classes for WAKIX
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
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 |