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Last Updated: May 5, 2024

Acalabrutinib maleate - Generic Drug Details

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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

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

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

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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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a 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
Hungary	E049989		⤷ Try a Trial
Ukraine	83509	ІМІДАЗОПІРАЗИНИ ЯК ІНГІБІТОРИ ТИРОЗИНКІНАЗ[ИМИДАЗОПИРАЗИНЫ КАК ИНГИБИТОРЫ ТИРОЗИНКИНАЗ (IMIDAZOPYRAZINES AS TYROSINE KINASE INHIBITORS)	⤷ Try a Trial
Australia	2020277123	Solid forms and formulations of (S)-4-(8-amino-3-(1 -(but-2-ynoyl)pyrrolidin-2-yl)imidazo(1,5-a)pyrazin-1-yl)-N-(pyridin-2-yl)benzamide	⤷ Try a Trial
European Patent Office	3954690	FORMES ET FORMULATIONS SOLIDES DE (S)-4-(8-AMINO-3-(1-(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1,5-A]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)BENZAMIDE (SOLID FORMS AND FORMULATIONS OF (S)-4-(8-AMINO-3-(1-(BUT-2-YNOYL)PYRROLIDIN-2-YL)IMIDAZO[1,5-A]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)BENZAMIDE)	⤷ Try a Trial
European Patent Office	3689878	4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES ET 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES EN TANT QU'INHIBITEURS BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS)	⤷ Try a Trial
India	408CHN2014		⤷ Try a 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	C02734522/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
2734522	C20210006 00368	Estonia	⤷ Try a Trial	PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020
2734522	122021000020	Germany	⤷ Try a Trial	PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
2734522	CR 2021 00007	Denmark	⤷ Try a Trial	PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	SPC/GB21/019	United Kingdom	⤷ Try a Trial	PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/20/1479 (NI) 20201106; UK PLGB 17901/0353 20201106
2734522	301097	Netherlands	⤷ Try a Trial	PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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