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 June 21, 2031. 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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Questions you can ask:
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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: | 94 |
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for WAKIX
Generic Entry Date for WAKIX*:
Constraining patent/regulatory exclusivity:
TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY 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.
Pharmacology for WAKIX
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.
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 TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) 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.
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
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEDIATRIC PATIENTS 6 YEARS OF AGE AND OLDER WITH NARCOLEPSY
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 | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | ⤷ 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 | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | ⤷ 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 |
Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | 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 |
---|---|---|---|
Denmark | 1100503 | ⤷ Sign Up | |
Poland | 1863487 | ⤷ Sign Up | |
Tunisia | SN07365 | TRAITEMENT DE LA MALADIE DE PARKINSON, DE L'APNEE OBSTRUCTIVE DU SOMMEIL, DE LA DEMENCE A CORPS DE LEWY, DE LA DEMENCE VASCULAIRE, AVEC DES LIGANDS DU RECEPTEUR H3 DE L'HISTAMINE NON-IMIDAZOLE-ALKYLAMINES | ⤷ Sign Up |
European Patent Office | 1428820 | Alkylamines sans imidazoles comme ligands de récepteur H-3 d'histamine et leurs applications therapeutiques (Non-imidazole alkylamines as histamine H-3-receptor ligands and their therapeutic applications) | ⤷ 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 | 2016/038 | Ireland | ⤷ Sign Up | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
1428820 | 2016C/048 | Belgium | ⤷ Sign Up | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404 |
1428820 | 300832 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404 |
1428820 | CR 2016 00042 | Denmark | ⤷ Sign Up | PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |