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Last Updated: November 25, 2020

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IMBRUVICA Drug Profile

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

Imbruvica is a drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-eight patents protecting this drug and four Paragraph IV challenges.

This drug has two hundred and ninety-four patent family members in forty-one countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

US ANDA Litigation and Generic Entry Outlook for Imbruvica

Imbruvica was eligible for patent challenges on November 13, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 30, 2033. This may change due to patent challenges or generic licensing.

There have been ten 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 IMBRUVICA
Drug Prices for IMBRUVICA

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Generic Entry Opportunity Date for IMBRUVICA
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for IMBRUVICA*:
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 IMBRUVICA

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

SponsorPhase
Guangdong 999 Brain HospitalPhase 2
Huiqiang HuangPhase 2
Nanfang Hospital of Southern Medical UniversityPhase 2

See all IMBRUVICA clinical trials

Pharmacology for IMBRUVICA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for IMBRUVICA
Tradename Dosage Ingredient NDA Submissiondate
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-12-14
IMBRUVICA CAPSULE;ORAL ibrutinib 205552 2018-12-14
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-11-05
IMBRUVICA CAPSULE;ORAL ibrutinib 205552 2017-11-13

US Patents and Regulatory Information for IMBRUVICA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for IMBRUVICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2529621 300868 Netherlands   Start Trial PRODUCT NAME: IBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/945 - C(2015)4704 20150707
2201840 92692 Luxembourg   Start Trial PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2529621 C20170010 00272 Estonia   Start Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
>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.