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Last Updated: June 25, 2021

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IMBRUVICA Drug Profile


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When do Imbruvica patents expire, 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-nine patents protecting this drug and four Paragraph IV challenges.

This drug has two hundred and ninety-seven 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.

DrugPatentWatch® Litigation and Generic Entry Outlook for Imbruvica

A generic version of IMBRUVICA was approved as ibrutinib by ZYDUS on March 31st, 2021.

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Drug patent expirations by year for IMBRUVICA
Drug Prices for IMBRUVICA

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Recent Clinical Trials for IMBRUVICA

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

SponsorPhase
M.D. Anderson Cancer CenterPhase 1
BayerPhase 2
Loxo Oncology, Inc.Phase 3

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 TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 AB RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   Get Started Free   Get Started Free Y Y   Get Started Free
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   Get Started Free   Get Started Free   Get Started Free
>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
2526934 93321 Luxembourg   Get Started Free PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
2529621 PA2017009 Lithuania   Get Started Free PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2201840 18/2015 Austria   Get Started Free PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2529621 C20170010 00272 Estonia   Get Started Free 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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
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McKesson
McKinsey

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