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Last Updated: February 7, 2023

Pitolisant hydrochloride - Generic Drug Details


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What are the generic drug sources for pitolisant hydrochloride and what is the scope of freedom to operate?

Pitolisant hydrochloride is the generic ingredient in one branded drug marketed by Harmony and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pitolisant hydrochloride has sixty-one patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for pitolisant hydrochloride
International Patents:61
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 52
Clinical Trials: 27
Patent Applications: 14
What excipients (inactive ingredients) are in pitolisant hydrochloride?pitolisant hydrochloride excipients list
DailyMed Link:pitolisant hydrochloride at DailyMed
Recent Clinical Trials for pitolisant hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Harmony Biosciences, LLCPhase 4
William Ondo, MDPhase 4
Harmony Biosciences, LLCPhase 3

See all pitolisant hydrochloride clinical trials

US Patents and Regulatory Information for pitolisant hydrochloride

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 211150-001 Aug 14, 2019 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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 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
>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 pitolisant hydrochloride

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 211150-001 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
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 pitolisant hydrochloride

Country Patent Number Title Estimated Expiration
Australia 2006228413 Treatment of Parkinson's Disease, obstructive sleep apnea, dementia with lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006084833 See Plans and Pricing
Serbia 50624 MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE) See Plans and Pricing
European Patent Office 1707203 Utilization des allkylamines sans imidazoles comme ligandes du recepteur histamine H3 pour le traitement de la maladie de Parkinson, de l'apnee obstructive du sommeil, de la demence vasculaire et de la demence avec corps de Lewy (Treatment of parkinson's disease obstructive sleep apnea, dementia with lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3- receptor ligands) See Plans and Pricing
Cyprus 1108428 See Plans and Pricing
South Korea 20080002904 TREATMENT OF PARKINSONS'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pitolisant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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 CA 2016 00042 Denmark See Plans and Pricing PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820 300832 Netherlands See Plans and Pricing 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 See Plans and Pricing PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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