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Last Updated: April 22, 2024

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 Llc, and is included in four NDAs. There are forty-one 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 eighty-one patent family members in forty-five countries.

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

Drug Prices for ibrutinib

See drug prices for ibrutinib

Recent Clinical Trials for ibrutinib

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

SponsorPhase
Janssen Research & Development, LLCPhase 2/Phase 3
Pharmacyclics LLC.Phase 2/Phase 3
Beigene (Beijing) Biotechnology Co., LtdPhase 2

See all ibrutinib clinical trials

Generic filers with tentative approvals for IBRUTINIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial140MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial140MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial140MGTABLET;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 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 Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pharmacyclics Llc IMBRUVICA ibrutinib SUSPENSION;ORAL 217003-001 Aug 24, 2022 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 or venetoclax is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) (see section 5.1).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 295053 מעכבים של ברוטון טירוזין קינאז (Inhibitors of brutons tyrosine kinase) ⤷  Try a Trial
Cyprus 1117840 ⤷  Try a Trial
Chile 2017003496 Formas cristalinas de un inhibidor de tirosina quinasa de bruton. ⤷  Try a Trial
Cyprus 2017012 ⤷  Try a Trial
Eurasian Patent Organization 201300246 ИНГИБИТОРЫ ТИРОЗИНКИНАЗЫ БРУТОНА ⤷  Try a Trial
Spain 2673973 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for ibrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2529621 C20170010 00279 Estonia ⤷  Try a Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 07.07.2015
2201840 300728 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2526934 PA2016034 Lithuania ⤷  Try a Trial PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2201840 18/2015 Austria ⤷  Try a Trial PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 C300728 Netherlands ⤷  Try a Trial PRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 15C0029 France ⤷  Try a Trial PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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