ASCIMINIB HYDROCHLORIDE - Generic Drug Details

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

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

Sponsor	Phase
Novartis	Phase 3
Sarit Assouline	Phase 3
Augusta University	Phase 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				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No				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				Y
Novartis	SCEMBLIX	asciminib hydrochloride	TABLET;ORAL	215358-001	Oct 29, 2021		RX	Yes	No

International Patents for ASCIMINIB HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Taiwan	201400471	Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Chile	2014002757	Compuestos derivados de benzamida para inhibir la actividad de abl1, abl2 y bcr-abl1, composicion farmaceutica; y uso en el tratamiento del cancer.
South Africa	201407065	BENZAMIDE DERIVATIVES FOR INHIBITING THE ACTIVITY OF ABL1, ABL2 AND BCR-ABL1
Norway	2022043
Guatemala	201400253	DERIVADOS DE BENZAMIDA PARA LA INHIBICIÓN DE LA ACTIVIDAD DE ABL1, ABL2 Y BCR-ABL1

Supplementary Protection Certificates for ASCIMINIB HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2861579	2290039-3	Sweden		PRODUCT NAME: ASCIMINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, SUCH AS ASCIMINIB HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1670 20220826
2861579	C20220039 00385	Estonia		PRODUCT NAME: ASTSIMINIIB;REG NO/DATE: EU/1/22/1670 26.08.2022
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	301201	Netherlands		PRODUCT NAME: ASCIMINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ASCIMINIBHYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1670 20220826
2861579	PA2022523	Lithuania		PRODUCT NAME: ASCIMINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA, TOKIA KAIP ASCIMINIBO HIDROCHLORIDAS; REGISTRATION NO/DATE: EU/1/22/1670 20220825