Acalabrutinib - Generic Drug Details

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

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

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

One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for acalabrutinib

International Patents:	183
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	53
Clinical Trials:	137
Patent Applications:	1,237
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for acalabrutinib
What excipients (inactive ingredients) are in acalabrutinib?	acalabrutinib excipients list
DailyMed Link:	acalabrutinib at DailyMed

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

Generic Entry Date for acalabrutinib^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: CAPSULE;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.

Recent Clinical Trials for acalabrutinib

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Mayur Narkhede	Phase 1
ADC Therapeutics S.A.	Phase 1
Merck Sharp & Dohme LLC	Phase 3

See all acalabrutinib clinical trials

Generic filers with tentative approvals for ACALABRUTINIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	100MG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acalabrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for acalabrutinib

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

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
CALQUENCE	Capsules	acalabrutinib	100 mg	210259	5	2021-11-01

US Patents and Regulatory Information for acalabrutinib

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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	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Astrazeneca	CALQUENCE	acalabrutinib	CAPSULE;ORAL	210259-001	Oct 31, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for acalabrutinib

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AstraZeneca AB	Calquence	acalabrutinib	EMEA/H/C/005299 Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.	Authorised	no	no	no	2020-11-05
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for acalabrutinib

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Country	Patent Number	Title	Estimated Expiration
South Africa	202000300	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
Eurasian Patent Organization	201490300	4-ИМИДАЗОПИРИДАЗИН-1-ИЛ-БЕНЗАМИДЫ И 4-ИМИДАЗОТРИАЗИН-1-ИЛ-БЕНЗАМИДЫ В КАЧЕСТВЕ BTK-ИНГИБИТОРОВ	⤷ Sign Up
Nicaragua	201400004	4 - IMIDAZOPIRIDAZIN - 1 - IL - BENZAMIDAS Y 4 - IMIDAZOTRIAZIN - 1 - IL - BENZAMIDAS COMO INHIBIDORES DE BTK	⤷ Sign Up
China	113480542	化合物的固体形式和制剂 (Solid forms and formulations of compound)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for acalabrutinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2734522	2190009-7	Sweden	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. 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	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	CR 2021 00007	Denmark	⤷ Sign Up	PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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