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Last Updated: June 25, 2022

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 thirty-one patent family members in forty-three 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
Shayna Sarosiek, MDPhase 2
ADC TherapeuticsPhase 2
GenmabPhase 2

See all IBRUTINIB clinical trials

Generic filers with tentative approvals for IBRUTINIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing140MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing140MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing140MGTABLET;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 Action Protein Kinase Inhibitors
Paragraph IV (Patent) Challenges for IBRUTINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
IMBRUVICA Capsules ibrutinib 70 mg 205552 1 2018-12-14
IMBRUVICA Tablets ibrutinib 280 mg and 420 mg 210563 1 2018-12-14
IMBRUVICA Tablets ibrutinib 140 mg and 560 mg 210563 1 2018-11-05
IMBRUVICA Capsules ibrutinib 140 mg 205552 8 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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

EU/EMA Drug Approvals for IBRUTINIB

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Janssen-Cilag International NV Imbruvica ibrutinib EMEA/H/C/003791
Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Imbruvica as a single agent or in combination with rituximab or obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. Imbruvica in combination with rituximab is indicated for the treatment of adult patients with WM.Imbruvica as a single agent is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).Imbruvica as a single agent or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).Imbruvica as a single agent or in combination with bendamustine and rituximab (BR) is indicated for the treatment of adult patients with CLL who have received at least one prior therapy.Imbruvica as a single agent is indicated for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo immunotherapy. Imbruvica in combination with rituximab is indicated for the treatment of adult patients with WM.
Authorised no no no 2014-10-21
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for IBRUTINIB

Country Patent Number Title Estimated Expiration
Israel 285843 See Plans and Pricing
Israel 239156 See Plans and Pricing
Luxembourg C00011 See Plans and Pricing
Philippines 12020500028 CRYSTALLINE FORMS OF A BRUTON`S TYROSINE KINASE INHIBITOR See Plans and Pricing
South Korea 20130086957 THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK) See Plans and Pricing
South Korea 20090091115 INHIBITORS OF BRUTON'S TYROSINE KINASE See Plans and Pricing
Canada 3001152 INHIBITEURS DE LA TYROSINE KINASE DE BRUTON (INHIBITORS OF BRUTON'S TYROSINE KINASE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IBRUTINIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2526934 93321 Luxembourg See Plans and Pricing PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
2529621 PA2017009 Lithuania See Plans and Pricing PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2201840 18/2015 Austria See Plans and Pricing PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2529621 C20170010 00272 Estonia See Plans and Pricing PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2201840 233 5006-2015 Slovakia See Plans and Pricing PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2201840 300728 Netherlands See Plans and Pricing DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2526934 C20160038 00313 Estonia See Plans and Pricing PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Harvard Business School
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