Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

Merck
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AstraZeneca
McKesson
Moodys
Medtronic

Last Updated: November 15, 2019

DrugPatentWatch Database Preview

CALQUENCE Drug Profile

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When do Calquence patents expire, and what generic alternatives are available?

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

This drug has ninety-five patent family members in thirty-nine countries.

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

Drug patent expirations by year for CALQUENCE
Drug Prices for CALQUENCE

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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
M.D. Anderson Cancer CenterPhase 2
ECOG-ACRIN Cancer Research GroupPhase 2
Stichting Hemato-Oncologie voor Volwassenen NederlandPhase 2/Phase 3

See all CALQUENCE clinical trials

Recent Litigation for CALQUENCE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Acerta Pharma B v. v. Pharmacyclics LLC2018-04-18

See all CALQUENCE litigation

Pharmacology for CALQUENCE
Drug ClassKinase Inhibitor
Mechanism of ActionTyrosine Kinase Inhibitors
Synonyms for CALQUENCE
(S)-4-(8-amino-3-(1-but-2-ynoylpyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide
1420477-60-6
4-[8-Amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl]imidazo[1,5-a]pyrazin-1-yl]-N-2-pyridinylbenzamide
4-[8-amino-3-[(2S)-1-but-2-ynoylpyrrolidin-2-yl]imidazo[1,5-a]pyrazin-1-yl]-N-pyridin-2-ylbenzamide
Acalabrutinib
Acalabrutinib (ACP-196)
Acalabrutinib (JAN/USAN/INN)
Acalabrutinib [INN]
Acalabrutinib [USAN:INN]
Acalabrutinib(ACP196)
ACP 196
ACP-196
ACP-196;Acalabrutinib
AK546544
AKOS030526094
BDBM50175583
Benzamide, 4-(8-amino-3-((2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl)imidazo(1,5-a)pyrazin-1-yl)-N-2-pyridinyl-
Calquence (TN)
CHEMBL3707348
CS-5356
D10893
DB11703
DS-3326
EX-A881
Example 6 [US20140155385 A1]
GTPL8912
HY-17600
I42748ELQW
J-690166
KS-000006AD
KS-000006AT
NCGC00479074-01
s8116
SB19176
SC-41557
SCHEMBL14637368
UNII-I42748ELQW
WDENQIQQYWYTPO-IBGZPJMESA-N
ZINC208774715

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

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Serving leading biopharmaceutical companies globally:

Medtronic
McKesson
Colorcon
AstraZeneca
Johnson and Johnson
Harvard Business School

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 verifification 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.