DrugPatentWatch Database Preview
Pitolisant hydrochloride - Generic Drug Details
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.
Summary for pitolisant hydrochloride
| International Patents: | 61 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 46 |
| Clinical Trials: | 23 |
| Patent Applications: | 3 |
| 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 |
|---|---|
| Boston Medical Center | Phase 1 |
| Harmony Biosciences, LLC | Phase 2 |
| Ferox Therapeutics | 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 | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | RX | Yes | Yes | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-001 | Aug 14, 2019 | RX | Yes | No | ⤷ Try it Free | ⤷ Try it Free | ⤷ Try it Free | ||||
| >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 it Free | ⤷ Try it Free |
| Harmony | WAKIX | pitolisant hydrochloride | TABLET;ORAL | 211150-002 | Aug 14, 2019 | ⤷ Try it Free | ⤷ Try it Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for pitolisant hydrochloride
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| South Korea | 101308527 | ⤷ Try it Free |
| Ukraine | 94902 | ⤷ Try it Free |
| Austria | 402154 | ⤷ Try it Free |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for pitolisant hydrochloride
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1428820 | CA 2016 00042 | Denmark | ⤷ Try it Free | PRODUCT NAME: PITOLISANT OG FARMACEUTISK ACCEPTABLE SALTE HERAF, SASOM PITOLISANT HYDROCHLORID; REG. NO/DATE: EU/1/15/1068 20160404 |
| 1428820 | SPC/GB16/052 | United Kingdom | ⤷ Try it Free | PRODUCT NAME: PITOLISANT AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF, SUCH AS HYDROCHLORIDE; REGISTERED: UK EU/1/15/1068 20160404 |
| 1428820 | 40/2016 | Austria | ⤷ Try it Free | 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 |
