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.
Summary for IBRUTINIB
International Patents: | 331 |
US Patents: | 40 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 82 |
Clinical Trials: | 344 |
Patent Applications: | 620 |
Formulation / Manufacturing: | see details |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IBRUTINIB |
What excipients (inactive ingredients) are in IBRUTINIB? | IBRUTINIB excipients list |
DailyMed Link: | IBRUTINIB at DailyMed |
Recent Clinical Trials for IBRUTINIB
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Shayna Sarosiek, MD | Phase 2 |
ADC Therapeutics | Phase 2 |
Genmab | Phase 2 |
Generic filers with tentative approvals for IBRUTINIB
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 140MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 140MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 140MG | TABLET;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 Class | Kinase 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
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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