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Last Updated: February 26, 2021

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IBRUTINIB - Generic Drug Details

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What are the generic drug sources for ibrutinib and what is the scope of freedom to operate?

Ibrutinib is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibrutinib has two hundred and ninety-six patent family members in forty-one countries.

There are sixteen drug master file entries for ibrutinib. One supplier is listed for this compound.

Recent Clinical Trials for IBRUTINIB

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

SponsorPhase
SobiPhase 1
Dr. David SpanerPhase 1
Loxo Oncology, Inc.Phase 3

See all IBRUTINIB clinical trials

Pharmacology for IBRUTINIB
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for IBRUTINIB
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 IBRUTINIB

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 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No   Start Trial   Start Trial Y   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No   Start Trial   Start Trial 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 IBRUTINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2201840 C20150014 00145 Estonia   Start Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2529621 C20170010 00272 Estonia   Start Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2201840 122015000027 Germany   Start Trial PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 PA2015017,C2201840 Lithuania   Start Trial PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 233 5006-2015 Slovakia   Start Trial PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Harvard Business School
Mallinckrodt
Colorcon
Moodys

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