Pitolisant hydrochloride - Generic Drug Details
✉ Email this page to a colleague
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: | 55 |
| Clinical Trials: | 28 |
| Patent Applications: | 9 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for pitolisant hydrochloride |
| What excipients (inactive ingredients) are in pitolisant hydrochloride? | pitolisant hydrochloride excipients list |
| DailyMed Link: | pitolisant hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for pitolisant hydrochloride
*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
| Sponsor | Phase |
|---|---|
| University of Oxford | N/A |
| William Ondo, MD | Phase 4 |
| Harmony Biosciences, LLC | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for pitolisant hydrochloride
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 | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >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 | 211150-002 | Aug 14, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pitolisant hydrochloride
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Austria | E391716 | ⤷ Sign Up | |
| Eurasian Patent Organization | 016007 | ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО СИНДРОМА АПНОЭ ВО СНЕ, СЛАБОУМИЯ С ТЕЛЬЦАМИ ЛЬЮИ, СОСУДИСТОЙ ДЕМЕНЦИИ С ПОМОЩЬЮ НЕ СОДЕРЖАЩИХ ИМИДАЗОЛ АЛКИЛАМИНОВЫХ ЛИГАНДОВ ГИСТАМИНОВЫХ Н-РЕЦЕПТОРОВ (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H-RECEPTOR LIGANDS) | ⤷ Sign Up |
| Ukraine | 94902 | ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНА, ДЕМЕНЦИИ С ТЕЛЬЦАМИ ЛЕВИ, СОСУДИСТОЙ ДЕМЕНЦИИ НЕИМИДАЗОЛЬНЫМИ АЛКИЛАМИНАМИ, КОТОРЫЕ ЯВЛЯЮТСЯ ЛИГАНДАМИ H3-РЕЦЕПТОРА ГИСТАМИНА;ЛІКУВАННЯ ХВОРОБИ ПАРКІНСОНА, ОБСТРУКТИВНОГО АПНОЕ СНУ, ДЕМЕНЦІЇ З ТІЛЬЦЯМИ ЛЕВІ, СУДИННОЇ ДЕМЕНЦІЇ НЕІМІДАЗОЛЬНИМИ АЛКІЛАМІНАМИ, ЯКІ Є ЛІГАНДАМИ H3-РЕЦЕПТОРА ГІСТАМІНУ (TREATMENT OF PARKINSON'S DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) | ⤷ Sign Up |
| Serbia | 52911 | LEČENJE SIMPTOMA PARKINSONOVE BOLESTI SA ALKILAMIN HISTAMINOM BEZ IMIDAZOLA - X3 - RECEPTORA LIGANDA (TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) | ⤷ Sign Up |
| Singapore | 147415 | TREATMENT OF PARKINSONÆS DISEASE, OBSTRUCTIVE SLEEP APNEA, DEMENTIA WITH LEWY BODIES, VASCULAR DEMENTIA WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS | ⤷ Sign Up |
| China | 101171009 | Treatment of parkinson's disease obstructive sleep apnea, dementia with lewy bodies, vascular dementia with non-imidazole alkylamines histamine h3- receptor ligands | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for pitolisant hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1428820 | 122016000073 | Germany | ⤷ Sign Up | PRODUCT NAME: PITOLISANT UND DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE, WIE DAS HYDROCHLORID; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | SPC/GB16/052 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404 |
| 1428820 | 1690039-1 | Sweden | ⤷ Sign Up | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE.; REG. NO/DATE: EU/15/1068 20160404 |
| 1428820 | 16C0038 | France | ⤷ Sign Up | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/15/1068 20160331 |
| 1428820 | 300832 | Netherlands | ⤷ Sign Up | PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404 |
| 1428820 | 2016C/048 | Belgium | ⤷ Sign Up | 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 |
