ASCIMINIB HYDROCHLORIDE - Generic Drug Details
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What are the generic drug sources for asciminib hydrochloride and what is the scope of patent protection?
Asciminib hydrochloride
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Asciminib hydrochloride has eighty-four patent family members in forty-nine countries.
One supplier is listed for this compound.
Summary for ASCIMINIB HYDROCHLORIDE
International Patents: | 84 |
US Patents: | 2 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 16 |
Patent Applications: | 2 |
DailyMed Link: | ASCIMINIB HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ASCIMINIB HYDROCHLORIDE
Generic Entry Date for ASCIMINIB 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 ASCIMINIB HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Novartis | Phase 3 |
Sarit Assouline | Phase 3 |
Augusta University | Phase 2 |
US Patents and Regulatory Information for ASCIMINIB HYDROCHLORIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-002 | Oct 29, 2021 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Novartis | SCEMBLIX | asciminib hydrochloride | TABLET;ORAL | 215358-001 | Oct 29, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 |
International Patents for ASCIMINIB HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
China | 114144232 | N-[4-(氯二氟甲氧基)苯基]-6-[(3R)-3-羟基吡咯烷-1-基]-5-(1H-吡唑-5-基)吡啶-3-甲酰胺的结晶形式 (Crystalline forms of n-[4-(chlorodifluoromethoxy) phenyl]-6-[(3r)-3-hydroxypyrrolidin-1-yl]-5-(1h-pyrazol-5-yl) pyridine-3-carboxamide) | ⤷ Try a Trial |
Costa Rica | 20140519 | DERIVADOS DE BENZAMIDA PARA LA INHIBICIÓN DE LA ACTIVIDAD DE ABL 1, ABL 2 Y BCR-ABL 1 | ⤷ Try a Trial |
Cuba | 24265 | COMPUESTOS DERIVADOS DE BENZAMIDA PARA INHIBIR LA ACTIVIDAD DE ABL1, ABL2 Y BCR-ABL1, ÚTILES EN EL TRATAMIENTO DEL CÁNCER | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ASCIMINIB HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2861579 | C20220039 00385 | Estonia | ⤷ Try a Trial | PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022 |
2861579 | C02861579/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68441 09.06.2022 |
2861579 | C202230056 | Spain | ⤷ Try a Trial | PRODUCT NAME: ASCIMINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO, TAL COMO HIDROCLORURO DE ASCIMINIB; NATIONAL AUTHORISATION NUMBER: EU/1/22/1670; DATE OF AUTHORISATION: 20220825; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1670; DATE OF FIRST AUTHORISATION IN EEA: 20220825 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |