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Last Updated: June 23, 2024

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SCEMBLIX Drug Patent Profile


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Which patents cover Scemblix, and what generic alternatives are available?

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 four FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

FDA Regulatory Exclusivity protecting SCEMBLIX

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷  Sign Up

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: ⤷  Sign Up

TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOID LEUKEMIA (PH+ CML) IN CHRONIC PHASE (CP) WITH THE T315I MUTATION
Exclusivity Expiration: ⤷  Sign Up

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  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 215358-001 Oct 29, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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
>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
Patent: Crystalline forms of N-(4-(chlorodifluoromethoxy)phenyl)-6-((3R)-3-hydroxypyrrolidin-1-yl)-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2021022712
Patent: Formas cristalinas de n-[4-(clorodifluorometóxi)fenil]-6-[(3r)-3-hidroxipirrolidin-1-il]-5-(1h-pirazol-5-il)piridina-3-carboxamida
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 39812
Patent: FORMES CRISTALLINES DE N-[4- (CHLORODIFLUOROMETHOXY) PHENYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE (CRYSTALLINE FORMS OF N-[4-(CHLORODIFLUOROMETHOXY)PHENYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 21003011
Patent: Formas cristalinas de n-[4-(clorodifluorometoxi)fenil]-6-[(3r)-3-hidroxipirrolidin-1-il]-5-(1h-pirazol-5-il)piridina-3-carboxamida
Estimated Expiration: ⤷  Sign Up

China

Patent: 4144232
Patent: 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)
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 69117
Patent: FORMES CRISTALLINES DE N-[4- (CHLORODIFLUOROMÉTHOXY) PHÉNYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE (CRYSTALLINE FORMS OF N-[4-(CHLORODIFLUOROMETHOXY)PHENYL]-6-[(3R)-3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAMIDE)
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 7995
Patent: צורות גבישיות של n-[4-(כלורודיפלואורומתוקסי)פניל]-6-[(r3)-3-הידרוקסיפירולידין-1-יל]-5-(h1-פירזול-5-יל)פירידין-3-קרבוקסמיד (Crystalline forms of n-[4-(chlorodifluoromethoxy)phenyl]-6-[(3r)-3-hydroxypyrrolidin-1-yl]-5-(1h-pyrazol-5-yl)pyridine-3-carboxamide)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 22532404
Patent: 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
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 21013970
Patent: FORMAS CRISTALINAS DE N-[4-(CLORODIFLUOROMETOXI)FENIL]-6-[(3R)-3-H IDROXIPIRROLIDIN-1-IL]-5-(1H-PIRAZOL-5-IL)PIRIDINA-3-CARBOXAMIDA. (CRYSTALLINE FORMS OF N-[4-(CHLORODIFLUOROMETHOXY)PHENYL]-6-[(3R)- 3-HYDROXYPYRROLIDIN-1-YL]-5-(1H-PYRAZOL-5-YL)PYRIDINE-3-CARBOXAM IDE.)
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 220009414
Patent: N-[4-페닐]-6-[(3R)-3-히드록시피롤리딘-1-일]-5-(1H-피라졸-5-일)피리딘-3-카복사미드의 결정질 형태
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 2110823
Patent: Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
Estimated Expiration: ⤷  Sign Up

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 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 20220009414 N-[4-페닐]-6-[(3R)-3-히드록시피롤리딘-1-일]-5-(1H-피라졸-5-일)피리딘-3-카복사미드의 결정질 형태 ⤷  Sign Up
Mexico 359014 DERIVADOS DE BENZAMIDA PARA LA INHIBICION DE LA ACTIVIDAD DE ABL1, ABL2 Y BCR-ABL1. (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1.) ⤷  Sign Up
China 104302634 Benzamide derivatives for inhibiting the activity of ABL1, ABL2 and BCR-ABL1 ⤷  Sign Up
Argentina 091063 COMPUESTOS Y COMPOSICIONES PARA INHIBIR LA ACTIVIDAD DE LA ABL1, ABL2 Y BCR-ABL1 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SCEMBLIX

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2861579 C20220039 00385 Estonia ⤷  Sign Up PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022
2861579 2290039-3 Sweden ⤷  Sign Up PRODUCT NAME: ASCIMINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS ASCIMINIB HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1670 20220826
2861579 C202230056 Spain ⤷  Sign Up 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
2861579 2022C/548 Belgium ⤷  Sign Up PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826
2861579 PA2022523 Lithuania ⤷  Sign Up PRODUCT NAME: ASCIMINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TOKIA KAIP ASCIMINIBO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/22/1670 20220825
>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.