PITOLISANT HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for pitolisant hydrochloride and what is the scope of patent protection?
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
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
| Sponsor | Phase |
|---|---|
| University of Oxford | N/A |
| William Ondo, MD | Phase 4 |
| Harmony Biosciences, LLC | Phase 4 |
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 | ⤷ 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 | ||||
| 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 | Y | Y | ⤷ 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 | 211150-002 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for PITOLISANT HYDROCHLORIDE
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Montenegro | 01713 | LIJEČENJE SIMPTOMA PARKINSONOVE BOLESTI SA ALKILAMIN HISTAMINOM BEZ IMIDAZOLA-H3 RECEPTORA UGANDA (TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) | ⤷ Try a Trial |
| Slovenia | 1846384 | ⤷ Try a Trial | |
| South Africa | 200708086 | Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H3-receptor ligands | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2006084833 | ⤷ Try a Trial | |
| European Patent Office | 1863487 | UTILISATION DES ALKYLAMINES SANS IMIDAZOLES COMME LIGANDES DU RECEPTEUR HISTAMINE H3 POUR LE TRAITEMENT DES SYMPTÔMES DE LA MALADIE DE PARKINSON (TREATMENT OF SYMPTOMS OF PARKINSON'S DISEASE WITH NON-IMIDAZOLE ALKYLAMINES HISTAMINE H3-RECEPTOR LIGANDS) | ⤷ Try a Trial |
| Eurasian Patent Organization | 200702135 | ЛЕЧЕНИЕ БОЛЕЗНИ ПАРКИНСОНА, ОБСТРУКТИВНОГО СИНДРОМА АПНОЭ ВО СНЕ, СЛАБОУМИЯ С ТЕЛЬЦАМИ ЛЬЮИ, СОСУДИСТОЙ ДЕМЕНЦИИ С ПОМОЩЬЮ НЕ СОДЕРЖАЩИХ ИМИДАЗОЛА АЛКИЛАМИНОВЫХ ЛИГАНДОВ ГИСТАМИНОВЫХ Н3-РЕЦЕПТОРОВ | ⤷ Try a Trial |
| Denmark | 1846384 | ⤷ 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 | 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 |
| 1428820 | 300832 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PITOLISANT EN FARMACEUTISCH AANVAARDBARE ZOUTEN DAARVAN, ZOALS HET HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/15/1068/002 20160404 |
| 1428820 | CA 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 | 16C0038 | France | ⤷ Try a Trial | PRODUCT NAME: PITOLISANT ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES TELS QUE LE CHLORHYDRATE; 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 | 40/2016 | Austria | ⤷ Try a 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 |
