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Last Updated: June 20, 2024

ASCIMINIB HYDROCHLORIDE - Generic Drug Details


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What are the generic 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

SponsorPhase
Sarit AssoulinePhase 3
NovartisPhase 3
Augusta UniversityPhase 2

See all ASCIMINIB HYDROCHLORIDE clinical trials

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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-003 Apr 18, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-001 Oct 29, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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
Chile 2021003011 Formas cristalinas de n-[4-(clorodifluorometoxi)fenil]-6-[(3r)-3-hidroxipirrolidin-1-il]-5-(1h-pirazol-5-il)piridina-3-carboxamida ⤷  Sign Up
Eurasian Patent Organization 024391 ПРОИЗВОДНЫЕ БЕНЗАМИДА ДЛЯ ИНГИБИРОВАНИЯ АКТИВНОСТИ ABL1, ABL2 И BCR-ABL1 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1) ⤷  Sign Up
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) ⤷  Sign Up
South Korea 20150008406 BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1 ⤷  Sign Up
Malaysia 169377 BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1 ⤷  Sign Up
Japan 6078639 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ASCIMINIB HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861579 C02861579/01 Switzerland ⤷  Sign Up PRODUCT NAME: ASCIMINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68441 09.06.2022
2861579 C20220039 00385 Estonia ⤷  Sign Up PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022
2861579 45/2022 Austria ⤷  Sign Up PRODUCT NAME: ASCIMINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, WIE ASCIMINIB-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1670 (MITTEILUNG) 20220826
2861579 22C1053 France ⤷  Sign Up PRODUCT NAME: ASCIMINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TEL QUE LE CHLORHYDRATE D'ASCIMINIB; REGISTRATION NO/DATE: EU/1/22/1670 20220826
2861579 122022000072 Germany ⤷  Sign Up PRODUCT NAME: ASCIMINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON, WIE ZUM BEISPIEL ASCIMINIBHYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1670 20220825
2861579 CR 2022 00046 Denmark ⤷  Sign Up PRODUCT NAME: ASCIMINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SASOM ASCIMINIB HYDROKLORID; REG. NO/DATE: EU/1/22/1670 20220826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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