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Last Updated: March 29, 2024

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CALQUENCE Drug Patent Profile


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When do Calquence patents expire, and when can generic versions of Calquence launch?

Calquence is a drug marketed by Astrazeneca and is included in two NDAs. There are nine patents protecting this drug and one Paragraph IV challenge.

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

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

DrugPatentWatch® Generic Entry Outlook for Calquence

Calquence was eligible for patent challenges on October 31, 2021.

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 have been six patent litigation cases 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

See drug prices for CALQUENCE

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for CALQUENCE
Generic Entry Dates for CALQUENCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for CALQUENCE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for CALQUENCE

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

SponsorPhase
Jeremy Abramson, MDPhase 2
Ohio State University Comprehensive Cancer CenterPhase 2
Jonsson Comprehensive Cancer CenterPhase 1/Phase 2

See all CALQUENCE clinical trials

Pharmacology for CALQUENCE
Drug ClassKinase Inhibitor
Mechanism of ActionTyrosine Kinase Inhibitors
Paragraph IV (Patent) Challenges for CALQUENCE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
CALQUENCE Capsules acalabrutinib 100 mg 210259 5 2021-11-01

US Patents and Regulatory Information for CALQUENCE

CALQUENCE is protected by thirty-four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of CALQUENCE is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting CALQUENCE

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Pharmaceutical composition comprising a crystal form 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

4-imidazopyridazin-1-yl-benzamides as BTK inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100MG OF ACALABRUTINIB TWICE DAILY

Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA BY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

Crystal forms 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 maleate
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA


Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA BY ORALLY ADMINISTERING 100 MG OF ACALABRUTINIB TWICE DAILY IN COMBINATION WITH INTRAVENOUS ADMINISTRATION OF OBINUTUZUMAB

Imidazopyrazine tyrosine kinase inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as Btk inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-imidazopyridazin-1-yl-benzamides as Btk inhibitors
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA OR SMALL LYMPHOCYTIC LEUKEMIA

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH PREVIOUSLY UNTREATED CHRONIC LYMPHOCYTIC LEUKEMIA IN COMBINATION WITH OBINUTUZUMAB

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA

Crystal forms 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
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LEUKEMIA

FDA Regulatory Exclusivity protecting CALQUENCE

TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷  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
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 ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca CALQUENCE acalabrutinib CAPSULE;ORAL 210259-001 Oct 31, 2017 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

EU/EMA Drug Approvals for CALQUENCE

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 CALQUENCE

When does loss-of-exclusivity occur for CALQUENCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 16286548
Estimated Expiration: ⤷  Try a Trial

Patent: 20277123
Estimated Expiration: ⤷  Try a Trial

Patent: 22291635
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 91096
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 17003445
Estimated Expiration: ⤷  Try a Trial

China

Patent: 8349978
Estimated Expiration: ⤷  Try a Trial

Patent: 3480542
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0200934
Estimated Expiration: ⤷  Try a Trial

Patent: 0211511
Estimated Expiration: ⤷  Try a Trial

Patent: 0230417
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 24519
Estimated Expiration: ⤷  Try a Trial

Patent: 24815
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

Patent: 09493
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 50511
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 49989
Estimated Expiration: ⤷  Try a Trial

Patent: 56008
Estimated Expiration: ⤷  Try a Trial

Patent: 62258
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 6633
Estimated Expiration: ⤷  Try a Trial

Patent: 4066
Estimated Expiration: ⤷  Try a Trial

Patent: 3821
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 29215
Estimated Expiration: ⤷  Try a Trial

Patent: 91494
Estimated Expiration: ⤷  Try a Trial

Patent: 18522877
Estimated Expiration: ⤷  Try a Trial

Patent: 21073235
Estimated Expiration: ⤷  Try a Trial

Patent: 22120156
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3514
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 18000179
Estimated Expiration: ⤷  Try a Trial

Patent: 20014163
Estimated Expiration: ⤷  Try a Trial

Moldova, Republic of

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 297
Estimated Expiration: ⤷  Try a Trial

Patent: 817
Estimated Expiration: ⤷  Try a Trial

Patent: 556
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 18103913
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 411
Estimated Expiration: ⤷  Try a Trial

Patent: 455
Estimated Expiration: ⤷  Try a Trial

Patent: 195
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 201913796U
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 17281
Estimated Expiration: ⤷  Try a Trial

Patent: 13745
Estimated Expiration: ⤷  Try a Trial

Patent: 54690
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1800329
Estimated Expiration: ⤷  Try a Trial

Patent: 2000300
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 180048593
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 97987
Estimated Expiration: ⤷  Try a Trial

Patent: 95802
Estimated Expiration: ⤷  Try a Trial

Patent: 46489
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering CALQUENCE around the world.

Country Patent Number Title Estimated Expiration
Denmark 3317281 ⤷  Try a Trial
Hungary E056008 ⤷  Try a Trial
Australia 2014358868 Therapeutic combination of a PI3K inhibitor and a BTK inhibitor ⤷  Try a Trial
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) ⤷  Try a Trial
Russian Federation 2006116503 ИМИДАЗОПИРАЗИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ ТИРОЗИНКИНАЗ ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for CALQUENCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2734522 PA2021004,C2734522 Lithuania ⤷  Try a Trial PRODUCT NAME: AKALABRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/20/1479/001-EU/1/20/1479/002 20201105
2734522 2190009-7 Sweden ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/20/1479 20201106
2734522 132021000000047 Italy ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(CALQUENCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1479, 20201106
2734522 301097 Netherlands ⤷  Try a Trial PRODUCT NAME: ACALABRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/20/1479 20201106
2734522 2021016 Norway ⤷  Try a Trial PRODUCT NAME: AKALABRUTINIB; REG. NO/DATE: EU/1/20/1479 20201111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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. 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.