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Last Updated: May 10, 2021

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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.

Summary for pitolisant hydrochloride
International Patents:61
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 43
Clinical Trials: 22
Patent Applications: 3
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
Boston Medical CenterPhase 1
Harmony Biosciences, LLCPhase 2
Ferox TherapeuticsPhase 1

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 211150-002 Aug 14, 2019 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Get Started for $10   Get Started for $10   Get Started for $10
>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   Get Started for $10   Get Started for $10
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019   Get Started for $10   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pitolisant hydrochloride

Country Patent Number Estimated Expiration
European Patent Office 1690858   Get Started for $10
Singapore 147415   Get Started for $10
Montenegro 01103   Get Started for $10
World Intellectual Property Organization (WIPO) 2006103546   Get Started for $10
Mexico 2007009574   Get Started for $10
Brazil PI0612216   Get Started for $10
European Patent Office 1707203   Get Started for $10
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for pitolisant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 1690039-1 Sweden   Get Started for $10 PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404
1428820 300832 Netherlands   Get Started for $10 PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820 40/2016 Austria   Get Started for $10 PRODUCT NAME: PITOLISANT UND SEINE PHARMAZEUTISCH VERTRAEGLICHEN SALZE EINSCHLIESSLICH DEM HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 (MITTEILUNG) 20160404
1428820 CA 2016 00042 Denmark   Get Started for $10 PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820 2016/038 Ireland   Get Started for $10 PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 16C0038 France   Get Started for $10 PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 2016C/048 Belgium   Get Started for $10 PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Baxter
AstraZeneca
Harvard Business School
Moodys

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