Last Updated: August 15, 2026

acalabrutinib maleate - Profile

✉ Email this page to a colleague

« Back to Dashboard

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.

Acalabrutinib maleate has two hundred and twenty-five patent family members in fifty-one countries.

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: 9,290,504 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

+ Get email alerts for changes to this table

Subscribe to access the full database, or Start Trial
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	11,166,951	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	10,272,083	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,059,829	⤷ Start Trial	Y	Y		⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	9,758,524	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	11,771,696	⤷ Start Trial				⤷ Start Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	10,239,883	⤷ 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

Subscribe to access the full database, or Start Trial
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

Subscribe to access the full database, or Start Trial
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3179991	LUC50025	Luxembourg	⤷ Start Trial	PRODUCT NAME: CALQUENCE - ACALABRUTINIB; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20250602
2734522	2021016	Norway	⤷ Start Trial	PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
2734522	122021000020	Germany	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
3179991	CA 2025 00039	Denmark	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, I KOMBINATION MED VENETOCLAX MED ELLER UDEN OBINOTUZUMAB; REG. NO/DATE: EU/1/20/1479 20250603
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	SPC/GB21/019	United Kingdom	⤷ Start Trial	PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/20/1479 (NI) 20201106; UK PLGB 17901/0353 20201106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.