Acalabrutinib maleate - Generic Drug Details

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What are the generic drug 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-one patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for acalabrutinib maleate

International Patents:	181
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib maleate	TABLET;ORAL	216387-001	Aug 3, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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
Canada	2841886	4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES ET 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES EN TANT QU'INHIBITEURS DE BTK (4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1-YL-BENZAMIDES AS BTK-INHIBITORS)	⤷ Sign Up
European Patent Office	3613745	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)	⤷ Sign Up
Moldova, Republic of	3317281		⤷ Sign Up
Poland	2734522		⤷ Sign Up
Russian Federation	2405784	ИМИДАЗОПИРАЗИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ТИРОЗИНКИНАЗ (IMIDAZOPYRAZINES AS TYROSINE KINASE INHIBITORS)	⤷ Sign Up
South Korea	20140036324	4-IMIDAZOPYRIDAZIN-1-YL-BENZAMIDES AND 4-IMIDAZOTRIAZIN-1- YL-BENZAMIDES AS BTK-INHIBITORS	⤷ Sign Up
>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	21C1014	France	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522	SPC/GB21/019	United Kingdom	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/20/1479 (NI) 20201106; UK PLGB 17901/0353 20201106
2734522	C20210006 00368	Estonia	⤷ Sign Up	PRODUCT NAME: AKALABRUTINIIB;REG NO/DATE: EU/1/20/1479 06.11.2020
2734522	CA 2021 00007	Denmark	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
2734522	LUC00202	Luxembourg	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522	C02734522/01	Switzerland	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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