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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 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
| Sponsor | Phase |
|---|---|
| Harmony Biosciences, LLC | Phase 2 |
| Ferox Therapeutics | Phase 1 |
| Clayton A. Dehn | Phase 1 |
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 | 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 | 211150-002 | 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 | Y | Y | Start Trial | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 |
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 | Start Trial | Start Trial |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pitolisant hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1108428 | Start Trial |
| Uruguay | 29369 | Start Trial |
| Serbia | 52911 | Start Trial |
| World Intellectual Property Organization (WIPO) | 0006254 | Start Trial |
| Brazil | PI0612216 | Start Trial |
| World Intellectual Property Organization (WIPO) | 2006103546 | Start Trial |
| Canada | 2603656 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for pitolisant hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 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 |
| 1428820 | 16C0038 | France | Start Trial | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 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 | CA 2016 00042 | Denmark | Start Trial | PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404 |
| 1428820 | 2016C/048 | Belgium | Start Trial | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; AUTHORISATION NUMBER AND DATE: EU/1/15/1068 20160404 |
| 1428820 | 93229 | Luxembourg | Start Trial | PRODUCT NAME: ALKYLAMINES SANS IMIDAZOLES COMME LIGANDS DE RECEPTEUR H-3 D'HISTAMINE ET LEURS APPLICATIONS THERAPEUTIQUES, FIRST REGISTRATION DATE: 20160404 |
| 1428820 | 2016/038 | Ireland | Start Trial | 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 |
