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Last Updated: August 5, 2020

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PITOLISANT HYDROCHLORIDE - Generic Drug Details

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What are the generic 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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Pitolisant hydrochloride has eighty-four patent family members in thirty-three countries.

Summary for PITOLISANT HYDROCHLORIDE
International Patents:84
US Patents:5
Tradenames:1
Applicants:1
NDAs:1
Bulk Api Vendors: 41
Clinical Trials: 21
Patent Applications: 3
DailyMed Link:PITOLISANT HYDROCHLORIDE at DailyMed
Recent Clinical Trials for PITOLISANT HYDROCHLORIDE

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

SponsorPhase
Harmony Biosciences, LLCPhase 2
Ferox TherapeuticsPhase 1
Clayton A. DehnPhase 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 211150-001 Aug 14, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for PITOLISANT HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 122016000073 Germany   Start Trial PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 499 Finland   Start Trial
1428820 300832 Netherlands   Start Trial PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404
1428820 40/2016 Austria   Start Trial PRODUCT NAME: PITOLISANT UND SEINE PHARMAZEUTISCH VERTRAEGLICHEN SALZE EINSCHLIESSLICH DEM HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 (MITTEILUNG) 20160404
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
AstraZeneca
Medtronic
Harvard Business School
Colorcon
Merck

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