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-five patent family members in forty-six 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.
Summary for ibrutinib
International Patents: | 385 |
US Patents: | 41 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 4 |
Drug Master File Entries: | 16 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 99 |
Clinical Trials: | 351 |
Patent Applications: | 677 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for ibrutinib |
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 |
---|---|
Pharmacyclics LLC. | Phase 2/Phase 3 |
Janssen Research & Development, LLC | Phase 2/Phase 3 |
LanZhou University | Phase 2 |
Generic filers with tentative approvals for IBRUTINIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Try a Trial | ⤷ Try a Trial | 140MG | CAPSULE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 140MG | CAPSULE;ORAL |
⤷ Try a Trial | ⤷ Try a Trial | 560MG | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for ibrutinib
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 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 |
---|---|---|---|
China | 111265531 | 治疗和预防移植物抗宿主病的方法 (Methods of treating and preventing graft versus host disease) | ⤷ Try a Trial |
New Zealand | 601278 | Inhibitors of Bruton's tyrosine kinase | ⤷ Try a Trial |
South Africa | 201207075 | INHIBITORS OF BRUTON'S TYROSINE KINASE | ⤷ Try a Trial |
Tunisia | 2014000492 | CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR | ⤷ Try a Trial |
Israel | 300955 | (r)-1-(3-(4-אמינו-3-(4-פנוקסיפניל)-h1-פירזולו[4,3-d]פירימידין-1-יל)פיפרידין1-יל)פרופ-2-אן-1-און לשימוש כתרופה לטיפול בלוקמיה לימפוציטית כרונית או לימפומה לימפוציטית קטנה ((r)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1h-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin 1-yl)prop-2-en-1-one for use as a medicament for the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma) | ⤷ Try a Trial |
Brazil | 112012030625 | uso de inibidores de tirosina quinase de bruton (btk) | ⤷ Try a Trial |
European Patent Office | 2529622 | Inhibiteurs de la tyrosine kinase de bruton (Inhibitors of bruton's tyrosine kinase) | ⤷ 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 |
---|---|---|---|---|
2201840 | SPC/GB15/022 | United Kingdom | ⤷ Try a Trial | CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONS APPLICANT: PHARMACYCLICS LLC995 EAST ARQUES AVENUE, SUNNYVALE, CA 94085, UNITED STATES OF AMERICA PRODUCT: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF PRODUCT TYPE: MEDICINALAUTHORISED: UK EU/1/14/945 23 OCTOBER 2014 AUTHORISED EXTENSION: PATENT NO: EP2201840TITLE: INHIBITORS OF BRUTON'S TYROSINE KINASESPC NO: SPC/GB15/022DATE GRANTED: 15 OCTOBER 2020 MAXIMUM PERIOD EXPIRES ON: 22 OCTOBER 2029*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6860 DATED 11 NOVEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS. |
2201840 | 2015/020 | Ireland | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
2201840 | PA2015017 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
2529621 | LUC00011 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 20150707 |
2201840 | 122015000027 | Germany | ⤷ Try a Trial | PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
2526934 | C20160038 00313 | Estonia | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016 |
2529621 | PA2017009 | Lithuania | ⤷ Try a 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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