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Last Updated: September 24, 2021

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CALQUENCE Drug Patent Profile


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Which patents cover Calquence, and when can generic versions of Calquence launch?

Calquence is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in forty-six countries.

The generic ingredient in CALQUENCE is acalabrutinib. One supplier is listed for this compound. Additional details are available on the acalabrutinib profile page.

DrugPatentWatch® Generic Entry Outlook for Calquence

Calquence will be eligible for patent challenges on October 31, 2021. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 1, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for CALQUENCE
Drug Prices for CALQUENCE

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for CALQUENCE
Generic Entry Date for CALQUENCE*:
Constraining patent/regulatory exclusivity:
NDA:
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 CALQUENCE

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

SponsorPhase
Dana-Farber Cancer InstitutePhase 1/Phase 2
Johns Hopkins UniversityPhase 2
Emory UniversityPhase 2

See all CALQUENCE clinical trials

Pharmacology for CALQUENCE
Drug ClassKinase Inhibitor
Mechanism of ActionTyrosine Kinase Inhibitors

US Patents and Regulatory Information for CALQUENCE

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 CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 CALQUENCE

Country Patent Number Estimated Expiration
Israel 230511 ⤷  Free Forever Trial
Mexico 2014000746 ⤷  Free Forever Trial
European Patent Office 3613745 ⤷  Free Forever Trial
Eurasian Patent Organization 201992270 ⤷  Free Forever Trial
New Zealand 620085 ⤷  Free Forever Trial
Cyprus 1121174 ⤷  Free Forever Trial
Netherlands 301097 ⤷  Free Forever Trial
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for CALQUENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2734522 C02734522/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: ACALABRUTINIBUM; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67790 04.03.2021
2734522 PA2021004 Lithuania ⤷  Free Forever 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 LUC00202 Luxembourg ⤷  Free Forever Trial PRODUCT NAME: ACALABRUTINIBOU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522 CA 2021 00007 Denmark ⤷  Free Forever Trial PRODUCT NAME: ACALABRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/20/1479 20201106
2734522 2021C/512 Belgium ⤷  Free Forever Trial PRODUCT NAME: ACALABRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/20/1479 20201106
2734522 122021000020 Germany ⤷  Free Forever Trial PRODUCT NAME: ACALABRUTINIB ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/20/1479 20201105
2734522 301097 Netherlands ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Moodys
McKinsey
Johnson and Johnson
Merck
Colorcon
Boehringer Ingelheim

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