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Last Updated: July 16, 2024

imbruvica Drug Patent Profile


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When do Imbruvica patents expire, and when can generic versions of Imbruvica launch?

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-one 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

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Drug patent expirations by year for imbruvica
Drug Prices for imbruvica

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Recent Clinical Trials for imbruvica

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

SponsorPhase
Peter MacCallum Cancer Centre, AustraliaPhase 2
Oncternal Therapeutics, IncPhase 3
Academic and Community Cancer Research UnitedPhase 2

See all imbruvica clinical trials

Pharmacology for imbruvica
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
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 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
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX 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
>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
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 3832
Patent: FORMULACIONES FARMACÉUTICAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 8108
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Australia

Patent: 13271918
Patent: Crystalline forms of a bruton's tyrosine kinase inhibitor
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Patent: 16226279
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibtor
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Patent: 16250445
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 18211201
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 18211216
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 20239751
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 21240244
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor
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Patent: 23200435
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 23202671
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor
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Brazil

Patent: 2014030424
Patent: formas cristalinas de um inibidor de quinase de tirosina de bruton
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Patent: 2017018931
Patent: formulações farmacêuticas de um inibidor de tirosina quinase de bruton
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Canada

Patent: 75986
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 76695
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 91994
Patent: FORMULATION PHARMACEUTIQUE POUR ADMINISTRATION ORALE COMPRENANT DE L'IBRUTINIB (PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION COMPRISING IBRUTINIB)
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Patent: 15208
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 77990
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 77995
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 18491
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Chile

Patent: 14003306
Patent: Preparacion farmaceutica oral que comprende un inhibidor de tirosina quinasa de bruton y forma cristalina a del mismo.
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Patent: 17000371
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton
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Patent: 17003496
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton.
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China

Patent: 4736178
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 7427498
Patent: 布鲁顿氏酪氨酸激酶抑制剂的医药配方 (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR)
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Patent: 0354132
Patent: 布鲁顿酪氨酸激酶抑制剂的晶形 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Colombia

Patent: 40408
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 140558
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Dominican Republic

Patent: 014000274
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 017000152
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 022000096
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Ecuador

Patent: 14033163
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 19015794
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Eurasian Patent Organization

Patent: 1492082
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА
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European Patent Office

Patent: 54859
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 65084
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR)
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Guatemala

Patent: 1400281
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Hong Kong

Patent: 08803
Patent: 布魯頓酪氨酸激酶抑制劑的晶形 (CRYSTALLINE FORMS OF A BRUTONS TYROSINE KINASE INHIBITOR)
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Patent: 49015
Patent: 布魯頓氏酪氨酸激酶抑制劑的醫藥配方 (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR)
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Israel

Patent: 5894
Patent: צורות גבישיות של מעכב ברוטון טירוסין קינאז (Crystalline forms of a bruton's tyrosine kinase inhibitor)
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Patent: 3995
Patent: פורמולציות רוקחיות של מעכב ברוטון טירוסין קינאז (Pharmaceutical formulations of bruton's tyrosine kinase inhibitor)
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Patent: 2367
Patent: צורות גבישיות של מעכב ברוטון טירוסין קינאז (Crystalline forms of a bruton's tyrosine kinase inhibitor)
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Patent: 3284
Patent: פורמולציות רוקחיות של מעכב ברוטון טירוסין קינאז (Pharmaceutical formulations of bruton's tyrosine kinase inhibitor)
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Japan

Patent: 36071
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Patent: 37086
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Patent: 49076
Estimated Expiration: ⤷  Sign Up

Patent: 15518885
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態
Estimated Expiration: ⤷  Sign Up

Patent: 18012710
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 18048182
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 18507200
Patent: ブルトン型チロシンキナーゼ阻害剤の薬学的製剤
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Patent: 19203008
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 20015744
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON TYROSINE KINASE INHIBITOR)
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Patent: 21183617
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 21193095
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON TYROSINE KINASE INHIBITOR)
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Patent: 22141701
Patent: ブルトン型チロシンキナーゼ阻害剤の薬学的製剤
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Patent: 23162162
Patent: ブルトン型チロシンキナーゼ阻害剤の結晶形態 (CRYSTALLINE FORMS OF BRUTON TYROSINE KINASE INHIBITOR)
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Jordan

Patent: 0200222
Patent: أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون (CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR)
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Patent: 54
Patent: أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون (CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR)
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Malaysia

Patent: 7999
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Sign Up

Patent: 4911
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 8290
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
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Patent: 14014848
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
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Patent: 17011270
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
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Patent: 21012478
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
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Patent: 21015368
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
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Patent: 21015370
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
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Patent: 21015405
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
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Patent: 21015408
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
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Morocco

Patent: 711
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
Estimated Expiration: ⤷  Sign Up

Patent: 643
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON
Estimated Expiration: ⤷  Sign Up

Patent: 654
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 2548
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
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Patent: 3828
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 1932
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Sign Up

Patent: 4446
Patent: Pharmaceutical formulations of bruton’s tyrosine kinase inhibtor
Estimated Expiration: ⤷  Sign Up

Patent: 7725
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 150174
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 190390
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 014502681
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 020500028
Patent: CRYSTALLINE FORMS OF A BRUTON`S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 17133990
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА
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Singapore

Patent: 202101389T
Patent: CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR
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Patent: 202102078V
Patent: PHARMACEUTICAL FORMULATIONS OF A BRUTON’S TYROSINE KINASE INHIBITOR
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Patent: 201408067Y
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 201707122Q
Patent: PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR
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South Africa

Patent: 1907661
Patent: PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 2105174
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 2105175
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 2303227
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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South Korea

Patent: 150015021
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Patent: 170091785
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 170122220
Patent: 브루톤 타이로신 키나제 저해제의 약제학적 제제
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Patent: 190040370
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 200017549
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 210033067
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 220093389
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 230170108
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Taiwan

Patent: 32912
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Patent: 53041
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Patent: 62963
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Patent: 62964
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Patent: 33027
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Patent: 10588
Estimated Expiration: ⤷  Sign Up

Patent: 1402122
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 1636023
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Patent: 1811334
Patent: Crystalline forms of a bruton's tyrosine kinase inhibitor
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Patent: 1902483
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Patent: 1906612
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
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Patent: 2211924
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Patent: 2315634
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Tunisia

Patent: 14000492
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
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Ukraine

Patent: 4421
Patent: КРИСТАЛІЧНА ФОРМА ІНГІБІТОРУ ТИРОЗИНКІНАЗИ БРУТОНА (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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Patent: 6959
Patent: ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР ТИРОЗИНКІНАЗИ БРУТОНА
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Uruguay

Patent: 848
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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Patent: 740
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
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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.

Country Patent Number Title Estimated Expiration
Australia 2014339815 Methods of treating and preventing graft versus host disease ⤷  Sign Up
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) ⤷  Sign Up
Cyprus 1116295 ⤷  Sign Up
Denmark 2526934 ⤷  Sign Up
Morocco 41654 Formes cristallines d'un inhibiteur de tyrosine kinase de bruton ⤷  Sign Up
South Korea 20130086957 THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK) ⤷  Sign Up
Singapore 10201809111X THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for imbruvica

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2201840 CA 2015 00021 Denmark ⤷  Sign Up PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
2526934 C20160038 00313 Estonia ⤷  Sign Up PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 30.05.2016
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 233 5006-2015 Slovakia ⤷  Sign Up PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2529621 PA2017009 Lithuania ⤷  Sign Up PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2201840 1590021-0 Sweden ⤷  Sign Up PRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
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

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