wakix Drug Patent Profile
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Which patents cover Wakix, 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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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 ⤷ Subscribe.
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.
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 | ⤷ Subscribe | ⤷ Subscribe | ||||
Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
>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 | 7,169,928 | ⤷ Subscribe |
Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | 7,169,928 | ⤷ Subscribe |
Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | 7,910,605 | ⤷ Subscribe |
>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: ⤷ Subscribe
Austria
Patent: 91716
Estimated Expiration: ⤷ Subscribe
Patent: 02154
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
China
Patent: 1155793
Patent: Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine
Estimated Expiration: ⤷ Subscribe
Croatia
Patent: 0080446
Estimated Expiration: ⤷ Subscribe
Cyprus
Patent: 08428
Estimated Expiration: ⤷ Subscribe
Denmark
Patent: 46384
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Germany
Patent: 2005005941
Estimated Expiration: ⤷ Subscribe
Patent: 2006001938
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 72604
Estimated Expiration: ⤷ Subscribe
Patent: 08530050
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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: ⤷ Subscribe
Poland
Patent: 46384
Estimated Expiration: ⤷ Subscribe
Portugal
Patent: 46384
Estimated Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Slovenia
Patent: 46384
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 1344271
Estimated Expiration: ⤷ Subscribe
Patent: 070101381
Patent: MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE
Estimated Expiration: ⤷ Subscribe
Spain
Patent: 09948
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 93711
Estimated Expiration: ⤷ Subscribe
Patent: 0639157
Patent: New salt of 1-[3-[3-(4-chlorophenyl)propoxy]propyl]-piperidine
Estimated Expiration: ⤷ Subscribe
Uruguay
Patent: 369
Patent: NUEVA SAL DE 1-(-3-(3-(4-CLOROFENIL) PROPOXI(PROPIL) -PIPERIDINA
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Montenegro | 01103 | MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE) | ⤷ Subscribe |
World Intellectual Property Organization (WIPO) | 2006084833 | ⤷ Subscribe | |
Ukraine | 94902 | ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНА, ДЕМЕНЦИИ С ТЕЛЬЦАМИ ЛЕВИ, СОСУДИСТОЙ ДЕМЕНЦИИ НЕИМИДАЗОЛЬНЫМИ АЛКИЛАМИНАМИ, КОТОРЫЕ ЯВЛЯЮТСЯ ЛИГАНДАМИ H3-РЕЦЕПТОРА ГИСТАМИНА;ЛІКУВАННЯ ХВОРОБИ ПАРКІНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНУ, ДЕМЕНЦІЇ З ТІЛЬЦЯМИ ЛЕВІ, СУДИННОЇ ДЕМЕНЦІЇ НЕІМІДАЗОЛЬНИМИ АЛКІЛАМІНАМИ, ЯКІ Є ЛІГАНДАМИ H3-РЕЦЕПТОРА ГІСТАМІНУ (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for wakix
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1428820 | 499 | Finland | ⤷ Subscribe | |
1428820 | 122016000073 | Germany | ⤷ Subscribe | PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
1428820 | 93229 | Luxembourg | ⤷ Subscribe | PRODUCT NAME: ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H-3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES, FIRST REGISTRATION DATE: 20160404 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Wakix Market Analysis and Financial Projection Experimental
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