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
| Sponsor | Phase |
|---|---|
| Harmony Biosciences, LLC | Phase 4 |
| William Ondo, MD | Phase 4 |
| Harmony Biosciences, LLC | Phase 3 |
US Patents and Regulatory Information for pitolisant hydrochloride
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 |
