Acalabrutinib maleate - Generic Drug Details

What are the generic sources for acalabrutinib maleate and what is the scope of patent protection?

Acalabrutinib maleate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acalabrutinib maleate has one hundred and eighty patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for acalabrutinib maleate

International Patents:	180
US Patents:	7
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	10
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib maleate
DailyMed Link:	acalabrutinib maleate at DailyMed

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

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.

Pharmacology for acalabrutinib maleate

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib maleate

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for acalabrutinib maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes			Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes			Y	Y
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes

International Patents for acalabrutinib maleate

Country	Patent Number	Title	Estimated Expiration
South Korea	101802689
Norway	20062136
Israel	266894	(s) -4-(8-אמינו-3-(1-בוט-2-ינוייל-פירולידינ-2-יל) אימידאזו [5,1-a]פיראזינ-1-יל)-n-(פירידינ-2-יל)בנזאמיד כמעכבי btk ((s)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl) imidazo [1,5-a]pyrazin-1-yl)-n-(pyridin-2-yl)benzamide as btk - inhibitor)
Portugal	3954690
Lithuania	PA2021004
Eurasian Patent Organization	201992270	4-ИМИДАЗОПИРИДАЗИН-1-ИЛ-БЕНЗАМИДЫ И 4-ИМИДАЗОТРИАЗИН-1-ИЛ-БЕНЗАМИДЫ В КАЧЕСТВЕ BTK-ИНГИБИТОРОВ

Supplementary Protection Certificates for acalabrutinib maleate

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	301097	Netherlands		PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	21C1014	France		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	PA2021004,C2734522	Lithuania		PRODUCT NAME: AKALABRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522	2021016	Norway		PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522	2021C/512	Belgium		PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522	122021000020	Germany		PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105