Last Updated: October 1, 2026

acalabrutinib maleate - Profile

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What are the generic sources for acalabrutinib maleate and what is the scope of freedom to operate?

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

Summary for acalabrutinib maleate

International Patents:	225
US Patents:	8
Tradenames:	1
Applicants:	1
NDAs:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib maleate

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

Generic Entry Date for acalabrutinib maleate^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: ⤷ Start Trial 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.

Paragraph IV (Patent) Challenges for ACALABRUTINIB MALEATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Tablets	acalabrutinib maleate	100 mg	216387	1	2024-02-13

US Patents and Regulatory Information for acalabrutinib maleate

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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	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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 acalabrutinib maleate

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Country	Patent Number	Title	Estimated Expiration
Australia	2012285987		⤷ Start Trial
Australia	2016203837		⤷ Start Trial
Australia	2017279778		⤷ Start Trial
Australia	2019275591		⤷ Start Trial
Brazil	112014001255		⤷ Start Trial
Canada	2841886		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acalabrutinib maleate

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	PA2021004	Lithuania	⤷ Start Trial	PRODUCT NAME: AKALABRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522	12/2021	Austria	⤷ Start Trial	PRODUCT NAME: 4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDE UND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDE ALS BTK-INHIBITOREN; REGISTRATION NO/DATE: EU/1/20/1479 (MITTEILUNG) 20201106
2734522	2190009-7	Sweden	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	21C1014	France	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	2021C/512	Belgium	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
3179991	122025000057	Germany	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON, IN KOMBINATION MIT VENETOCLAX ODER EINEM PHARMAZEUTISCH UNBEDENKLICHEN SALZ DAVON, MIT ODER OHNE OBINUTUZUMAB; REGISTRATION NO/DATE: EU/1/20/1479 20250602
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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