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SCEMBLIX Drug Patent Profile

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

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

See drug prices for SCEMBLIX

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SCEMBLIX

NDA:

215358

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.

Anatomical Therapeutic Chemical (ATC) Classes for SCEMBLIX

L01EA	BCR-ABL tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SCEMBLIX

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

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

FDA Regulatory Exclusivity protecting SCEMBLIX

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				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-002	Oct 29, 2021		RX	Yes	Yes				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-002	Oct 29, 2021		RX	Yes	Yes
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No				Y

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

Brazil

Canada

Chile

China

European Patent Office

Israel

Japan

Mexico

South Korea

Taiwan

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
European Patent Office	2861579	COMPOSÉS ET COMPOSITIONS POUR INHIBER L'ACTIVITÉ D'ABL1, ABL2 ET BCR-ABL1 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1)
Australia	2013261127	Benzamide derivatives for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Singapore	11201407152X	BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1
Taiwan	202110823	Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide
Hong Kong	1203495	用於抑制 的活性的苯甲酰胺衍生物 (BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1 ABL1ABL2 BCR-ABL1)

Supplementary Protection Certificates for SCEMBLIX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861579	122022000072	Germany		PRODUCT NAME: ASCIMINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON, WIE ZUM BEISPIEL ASCIMINIBHYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1670 20220825
2861579	2022C/548	Belgium		PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN, ZOALS ASCIMINIB HYDROCHLORIDE; AUTHORISATION NUMBER AND DATE: EU/1/22/1670 20220826
2861579	C202230056	Spain		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	C02861579/01	Switzerland		PRODUCT NAME: ASCIMINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68441 09.06.2022
2861579	C20220039 00385	Estonia		PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022