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Last Updated: February 9, 2023

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 seventy-eight patent family members in forty-six 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:78
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 28
Patent Applications: 98
What excipients (inactive ingredients) are in SCEMBLIX?SCEMBLIX excipients list
DailyMed Link:SCEMBLIX at DailyMed
Drug patent expirations by year for SCEMBLIX
DrugPatentWatch® Estimated Generic Entry Opportunity 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 See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

FDA Regulatory Exclusivity protecting SCEMBLIX

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-001 Oct 29, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novartis SCEMBLIX asciminib hydrochloride TABLET;ORAL 215358-002 Oct 29, 2021 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2021022712
Estimated Expiration: See Plans and Pricing

Canada

Patent: 39812
Estimated Expiration: See Plans and Pricing

Chile

Patent: 21003011
Estimated Expiration: See Plans and Pricing

China

Patent: 4144232
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 69117
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7995
Estimated Expiration: See Plans and Pricing

Japan

Patent: 22532404
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 220009414
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 2110823
Estimated Expiration: See Plans and Pricing

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
South Africa 201407065 BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1 See Plans and Pricing
Argentina 091063 COMPUESTOS Y COMPOSICIONES PARA INHIBIR LA ACTIVIDAD DE LA ABL1, ABL2 Y BCR-ABL1 See Plans and Pricing
Japan 2022532404 N-[4-(クロロジフルオロメトキシ)フェニル]-6-[(3R)-3-ヒドロキシピロリジン-1-イル]-5-(1H-ピラゾール-5-イル)ピリジン-3-カルボキサミドの結晶性形態 See Plans and Pricing
Japan 2015520158 ABL1、ABL2およびBCR−ABL1の活性を阻害するためのベンズアミド誘導体 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SCEMBLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861579 CR 2022 00046 Denmark See Plans and Pricing PRODUCT NAME: ASCIMINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SASOM ASCIMINIB HYDROKLORID; REG. NO/DATE: EU/1/22/1670 20220826
2861579 301201 Netherlands See Plans and Pricing PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ASCIMINIBHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1670 20220826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
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Harvard Business School
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Mallinckrodt

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.