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Last Updated: April 24, 2024

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
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pitolisant hydrochloride
Generic Entry Date for pitolisant hydrochloride*:
Constraining patent/regulatory exclusivity:
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.

Recent Clinical Trials for pitolisant hydrochloride

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

SponsorPhase
University of OxfordN/A
William Ondo, MDPhase 4
Harmony Biosciences, LLCPhase 4

See all pitolisant hydrochloride clinical trials

Paragraph IV (Patent) Challenges for PITOLISANT HYDROCHLORIDE
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 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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-001 Aug 14, 2019 ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 ⤷  Try a Trial ⤷  Try a Trial
Harmony WAKIX pitolisant hydrochloride TABLET;ORAL 211150-002 Aug 14, 2019 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for pitolisant hydrochloride

Country Patent Number Title Estimated Expiration
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 ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006084833 ⤷  Try a Trial
Serbia 50624 MONOHIDROHLORIDNA SO 1-[3-[3-(4-HLOROFENIL)PROPOKSI]PROPIL]PIPERIDINA (MONOHYDROCHLORIDE SALT OF 1- [3- [3- (4-CHLOROPHENYL) PROPOXY] PROPYL] -PIPERIDINE) ⤷  Try a Trial
European Patent Office 1846384 SEL DE MONOHYDROCHLORIDE DE 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE (MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE) ⤷  Try a Trial
South Korea 20070101381 MONOHYDROCHLORIDE SALT OF 1-[3-[3-(4-CHLOROPHENYL)PROPOXY]PROPYL]-PIPERIDINE ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for pitolisant hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1428820 SPC/GB16/052 United Kingdom ⤷  Try a Trial PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404
1428820 122016000073 Germany ⤷  Try a Trial PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 CR 2016 00042 Denmark ⤷  Try a Trial PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404
1428820 2016/038 Ireland ⤷  Try a Trial PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068 20160331
1428820 2016C/048 Belgium ⤷  Try a Trial 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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