IMBRUVICA Drug Patent Profile
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Which patents cover Imbruvica, and what generic alternatives are available?
Imbruvica is a drug marketed by Pharmacyclics Llc and is included in three NDAs. There are fifty-four patents protecting this drug and four Paragraph IV challenges.
This drug has three hundred and ninety patent family members in forty-seven countries.
The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
DrugPatentWatch® Generic Entry Outlook for Imbruvica
Imbruvica was eligible for patent challenges on November 13, 2017.
There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are six tentative approvals for the generic drug (ibrutinib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for IMBRUVICA
International Patents: | 390 |
US Patents: | 54 |
Applicants: | 1 |
NDAs: | 3 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 98 |
Clinical Trials: | 151 |
Patent Applications: | 3,059 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for IMBRUVICA |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IMBRUVICA |
What excipients (inactive ingredients) are in IMBRUVICA? | IMBRUVICA excipients list |
DailyMed Link: | IMBRUVICA at DailyMed |
Recent Clinical Trials for IMBRUVICA
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Peter MacCallum Cancer Centre, Australia | Phase 2 |
Oncternal Therapeutics, Inc | Phase 3 |
Academic and Community Cancer Research United | Phase 2 |
Pharmacology for IMBRUVICA
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IMBRUVICA
Paragraph IV (Patent) Challenges for IMBRUVICA
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 IMBRUVICA
IMBRUVICA is protected by eighty-five US patents and eight FDA Regulatory Exclusivities.
Patents protecting IMBRUVICA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a bruton's tyrosine kinase inhibitor
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Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Methods of treating and preventing graft versus host disease
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
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Use of inhibitors of bruton's tyrosine kinase (Btk)
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Use of inhibitors of bruton's tyrosine kinase (BTK)
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Methods of treating and preventing graft versus host disease
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
Methods of treating and preventing graft versus host disease
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Crystalline forms of a brutons tyrosine kinase inhibitor
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Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
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Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION
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Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA
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Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Inhibitors of bruton's tyrosine kinase
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Inhibitors of bruton's tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Inhibitors of Bruton's tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Inhibitors of bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Inhibitors of bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Inhibitors of bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Inhibitors of bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Inhibitors of bruton's tyrosine kinase
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Inhibitors of bruton'S tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Use of inhibitors of bruton's tyrosine kinase (Btk)
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Inhibitors of bruton's tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Inhibitors of Bruton's tyrosine kinase
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Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Inhibitors of Bruton's tyrosine kinase
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Inhibitors of Bruton's tyrosine kinase
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Use of inhibitors of Bruton's tyrosine kinase (Btk)
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Inhibitors of Bruton's tyrosine kinase
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Crystalline forms of a bruton's tyrosine kinase inhibitor
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Methods of treating and preventing graft versus host disease
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Use of inhibitors of bruton's tyrosine kinase (BTK)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of bruton's tyrosine kinase (BTK)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (BTK)
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Use of inhibitors of bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Use of inhibitors of bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Use of inhibitors of bruton's tyrosine kinase (Btk)
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Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WITH 17P DELETION
Use of inhibitors of bruton's tyrosine kinase (Btk)
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Use of inhibitors of bruton'S tyrosine kinase (BTK)
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FDA Regulatory Exclusivity protecting IMBRUVICA
TREATMENT OF PEDIATRIC PATIENTS AGE 1 YEAR AND OLDER WITH CHRONIC GRAFT-VERSUS-HOST DISEASE (CGVHD) AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY
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FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
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NEW PATIENT POPULATION
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PEDIATRIC EXCLUSIVITY
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PEDIATRIC EXCLUSIVITY
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TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
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PEDIATRIC EXCLUSIVITY
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NEW PRODUCT
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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 | CAPSULE;ORAL | 205552-001 | Nov 13, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-004 | Feb 16, 2018 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pharmacyclics Llc | IMBRUVICA | ibrutinib | TABLET;ORAL | 210563-003 | Feb 16, 2018 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pharmacyclics Llc | IMBRUVICA | ibrutinib | CAPSULE;ORAL | 205552-002 | Dec 20, 2017 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
>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 IMBRUVICA
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 IMBRUVICA
When does loss-of-exclusivity occur for IMBRUVICA?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2844
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Patent: 3832
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Australia
Patent: 13271918
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Brazil
Patent: 2014030424
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Patent: 2017018931
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Canada
Patent: 75986
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Chile
Patent: 14003306
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China
Patent: 4736178
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Colombia
Patent: 40408
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Costa Rica
Patent: 140558
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Dominican Republic
Patent: 014000274
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Ecuador
Patent: 14033163
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Patent: 19015794
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Eurasian Patent Organization
Patent: 1492082
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European Patent Office
Patent: 54859
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Patent: 65084
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Guatemala
Patent: 1400281
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Hong Kong
Patent: 08803
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Israel
Patent: 5894
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Japan
Patent: 36071
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Jordan
Patent: 0200222
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Patent: 54
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Malaysia
Patent: 7999
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Patent: 4911
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Mexico
Patent: 8290
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Morocco
Patent: 711
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New Zealand
Patent: 2548
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Patent: 150174
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Philippines
Patent: 014502681
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Russian Federation
Patent: 17133990
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Singapore
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South Africa
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South Korea
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Taiwan
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Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering IMBRUVICA around the world.
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Singapore | 10201809111X | THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK) | ⤷ Sign Up |
South Korea | 20190040370 | 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR) | ⤷ Sign Up |
Taiwan | I620565 | ⤷ Sign Up | |
Australia | 2023202671 | Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor | ⤷ Sign Up |
Cyprus | 1119209 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IMBRUVICA
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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2201840 | 92692 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023 |
2201840 | 122015000027 | Germany | ⤷ Sign Up | PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021 |
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2201840 | C 2015 016 | Romania | ⤷ Sign Up | PRODUCT NAME: IBRUTINIB SAU O SARE FARMACEUTIC ACCEPTABILA A ACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/14/945; DATE OF NATIONAL AUTHORISATION: 20141021; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/945; DATE OF FIRST AUTHORISATION IN EEA: 20141021 |
2201840 | 15C0029 | France | ⤷ Sign Up | 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 |