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Last Updated: September 28, 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 two branded drugs marketed by Zydus and Pharmacyclics Inc, and is included in three NDAs. There are forty patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibrutinib has three hundred and nine patent family members in forty-two countries.

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

Recent Clinical Trials for ibrutinib

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

SponsorPhase
Chinese Academy of Medical SciencesPhase 2
Wuhan Si'an Medical Technology Co., LtdPhase 3
Wuhan Union Hospital, ChinaPhase 3

See all ibrutinib clinical trials

Generic filers with tentative approvals for IBRUTINIB
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial140MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial140MGCAPSULE;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial560MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 210563-001 Feb 16, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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
2526934 132016000119245 Italy ⤷  Free Forever Trial PRODUCT NAME: IBRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE PER IL TRATTAMENTO DI PAZIENTI ADULTI CON LEUCEMIA LINFOCITICA CRONICA (CLL) PRECEDENTEMENTE NON TRATTATA(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/945, 20160530
2526934 C20160038 00313 Estonia ⤷  Free Forever Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016
2526934 300844 Netherlands ⤷  Free Forever Trial PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2529621 PA2017009 Lithuania ⤷  Free Forever Trial PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Moodys
Colorcon
Express Scripts
McKinsey

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