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Last Updated: April 17, 2024

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SCEMBLIX Drug Patent Profile


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Which patents cover Scemblix, and when can generic versions of Scemblix launch?

Scemblix is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

This drug has eighty-four patent family members in forty-nine countries.

The generic ingredient in SCEMBLIX is asciminib hydrochloride. One supplier is listed for this compound. Additional details are available on the asciminib hydrochloride profile page.

DrugPatentWatch® Generic Entry Outlook for Scemblix

Scemblix will be eligible for patent challenges on October 29, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 14, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for SCEMBLIX
International Patents:84
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 4
Patent Applications: 1
Drug Prices: Drug price information for SCEMBLIX
What excipients (inactive ingredients) are in SCEMBLIX?SCEMBLIX excipients list
DailyMed Link:SCEMBLIX at DailyMed
Drug patent expirations by year for SCEMBLIX
Drug Prices for SCEMBLIX

See drug prices for SCEMBLIX

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SCEMBLIX
Generic Entry Date for SCEMBLIX*:
Constraining patent/regulatory exclusivity:
NDA:
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.

US Patents and Regulatory Information for SCEMBLIX

SCEMBLIX is protected by two US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SCEMBLIX is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting SCEMBLIX

Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(- 1H-pyrazol-5-yl)pyridine-3-carboxamide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)

FDA Regulatory Exclusivity protecting SCEMBLIX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP), PREVIOUSLY TREATED WITH TWO OR MORE TYROSINE KINASE INHIBITORS (TKIS)
Exclusivity Expiration: ⤷  Try a Trial

TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION
Exclusivity Expiration: ⤷  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
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-001 Oct 29, 2021 RX Yes No ⤷  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
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes ⤷  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 SCEMBLIX

When does loss-of-exclusivity occur for SCEMBLIX?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 20276701
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2021022712
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 39812
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 21003011
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4144232
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 69117
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 7995
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 22532404
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 21013970
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 220009414
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 2110823
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering SCEMBLIX around the world.

Country Patent Number Title Estimated Expiration
China 104302634 Benzamide derivatives for inhibiting the activity of ABL1, ABL2 and BCR-ABL1 ⤷  Try a Trial
China 104302638 Benzamide derivatives for inhibiting the activity of abl1, abl2 and bcr-abl1 ⤷  Try a Trial
Taiwan I560183 ⤷  Try a Trial
Brazil 112021022712 Formas cristalinas de n-[4-(clorodifluorometĂłxi)fenil]-6-[(3r)-3-hidroxipirrolidin-1-il]-5-(1h-pirazol-5-il)piridina-3-carboxamida ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SCEMBLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861579 2022C/548 Belgium ⤷  Try a Trial PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826
2861579 45/2022 Austria ⤷  Try a Trial PRODUCT NAME: ASCIMINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, WIE ASCIMINIB-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1670 (MITTEILUNG) 20220826
2861579 C02861579/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ASCIMINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68441 09.06.2022
2861579 22C1053 France ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.