Ibrutinib - Generic Drug Details
✉ Email this page to a colleague
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.
Summary for ibrutinib
International Patents: | 381 |
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 | 420MG | 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 |
---|---|---|---|
Israel | 245183 | שיטות לטיפול ומניעה של שתל נגד מחלה פונדקאית (Methods of treating and preventing graft versus host disease) | ⤷ Try a Trial |
Japan | 2010235628 | INHIBITOR OF BRUTON'S TYROSINE KINASE | ⤷ Try a Trial |
Singapore | 10201508035T | INHIBITORS OF BRUTON'S TYROSINE KINASE | ⤷ Try a Trial |
South Africa | 202208792 | METHODS OF TREATING AND PREVENTING GRAFT VERSUS HOST DISEASE | ⤷ Try a Trial |
Australia | 2020202752 | The use of inhibitors of Bruton's tyrosine kinase (Btk) | ⤷ Try a Trial |
Slovenia | 2526771 | ⤷ Try a Trial | |
Mexico | 2012014049 | EL USO DE INHIBIDORES DE LA TIROSINA QUINASA DE BRUTON (BTK). (THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK).) | ⤷ 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 | PA2015017 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIBUM; 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 |
2526934 | CA 2016 00056 | Denmark | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530 |
2529621 | 132017000036530 | Italy | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/4/945, 20150707 |
2529621 | 122017000015 | Germany | ⤷ Try a Trial | PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703 |
2201840 | 601 | Finland | ⤷ Try a Trial | |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.