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Last Updated: June 28, 2022

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 Inc and is included in two NDAs. There are forty patents protecting this drug and four Paragraph IV challenges.

This drug has three hundred and thirty-one patent family members in forty-three 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 eleven 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 five 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

See drug prices for IMBRUVICA

Recent Clinical Trials for IMBRUVICA

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

SponsorPhase
Academic and Community Cancer Research UnitedPhase 2
Loxo Oncology, Inc.Phase 3
Joseph TuscanoPhase 2

See all IMBRUVICA clinical trials

Pharmacology for IMBRUVICA
Drug ClassKinase Inhibitor
Mechanism of Action Protein 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 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-nine US patents and six FDA Regulatory Exclusivities.

Patents protecting IMBRUVICA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Pharmaceutical formulations of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF REFRACTORY CHRONIC GRAFT-VERSUS-HOST DISEASE

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE AFTER FAILURE OF ONE OR MORE LINES OF SYSTEMIC THERAPY

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT VERSUS HOST DISEASE REFRACTORY TO SYSTEMIC THERAPY

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF RELAPSED OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA

Crystalline forms of a brutons tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC SMALL LYMPHOCYTIC LEUKEMIA

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Inhibitors of bruton'S tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Inhibitors of bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LEUKEMIA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT FOR CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Use of inhibitors of Bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Inhibitors of Bruton's tyrosine kinase
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF SMALL LYMPHOCYTIC LYMPHOMA

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF WALDENSTROM'S MACROGLOBULINEMIA

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MANTLE CELL LYMPHOMA

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

Pharmaceutical formulations of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a Bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline forms of a bruton's tyrosine kinase inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods of treating and preventing graft versus host disease
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH CYCLOSPORIN-RESISTANT, STEROID-DEPENDENT/REFRACTORY, OR STEROID RESISTANT 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
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC GRAFT-VERSUS-HOST DISEASE

Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA

Use of inhibitors of bruton's tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA WITH 17P DELETION

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA

Use of inhibitors of bruton's tyrosine kinase (Btk)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA/SMALL LYMPHOCYTIC LYMPHOMA WITH 17P DELETION

Use of inhibitors of bruton'S tyrosine kinase (BTK)
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF MARGINAL ZONE LYMPHOMA

FDA Regulatory Exclusivity protecting IMBRUVICA

INFORMATION ADDED TO THE PRESCRIBING INFORMATION TO INCLUDE EFFICACY AND SAFETY DATA FROM A STUDY IN PATIENTS WITH TREATMENT NAIVE CLL/SLL TREATED WITH IBRUTINIB IN COMBINATION WITH OBINUTUZUMAB OR CHLORAMBUCIL IN COMBINATION WITH OBINUTUZUMAB
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF PATIENTS WITH MARGINAL ZONE LYMPHOMA (MZL) WHO REQUIRE SYSTEMIC THERAPY AND HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED THERAPY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA WITHOUT 17P DELETION WHO HAVE NOT RECEIVED AT LEAST ONE PRIOR THERAPY (FIRST LINE THERAPY)
Exclusivity Expiration: See Plans and Pricing

FOR TREATMENT OF PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH CHRONIC GRAFT VERSUS HOST DISEASE (CGVHD)
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 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 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
Estimated Expiration: See Plans and Pricing

Patent: 3832
Estimated Expiration: See Plans and Pricing

Patent: 8108
Estimated Expiration: See Plans and Pricing

Australia

Patent: 13271918
Estimated Expiration: See Plans and Pricing

Patent: 16226279
Estimated Expiration: See Plans and Pricing

Patent: 16250445
Estimated Expiration: See Plans and Pricing

Patent: 18211201
Estimated Expiration: See Plans and Pricing

Patent: 18211216
Estimated Expiration: See Plans and Pricing

Patent: 20239751
Estimated Expiration: See Plans and Pricing

Patent: 21240244
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2014030424
Estimated Expiration: See Plans and Pricing

Patent: 2017018931
Estimated Expiration: See Plans and Pricing

Canada

Patent: 75986
Estimated Expiration: See Plans and Pricing

Patent: 76695
Estimated Expiration: See Plans and Pricing

Patent: 91994
Estimated Expiration: See Plans and Pricing

Patent: 15208
Estimated Expiration: See Plans and Pricing

Chile

Patent: 14003306
Estimated Expiration: See Plans and Pricing

Patent: 17000371
Estimated Expiration: See Plans and Pricing

Patent: 17003496
Estimated Expiration: See Plans and Pricing

China

Patent: 4736178
Estimated Expiration: See Plans and Pricing

Patent: 7427498
Estimated Expiration: See Plans and Pricing

Patent: 0354132
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 40408
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 140558
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 014000274
Estimated Expiration: See Plans and Pricing

Patent: 017000152
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 14033163
Estimated Expiration: See Plans and Pricing

Patent: 19015794
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1492082
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 54859
Estimated Expiration: See Plans and Pricing

Patent: 65084
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1400281
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 08803
Estimated Expiration: See Plans and Pricing

Patent: 49015
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5894
Estimated Expiration: See Plans and Pricing

Patent: 3995
Estimated Expiration: See Plans and Pricing

Patent: 4739
Estimated Expiration: See Plans and Pricing

Patent: 2367
Estimated Expiration: See Plans and Pricing

Japan

Patent: 36071
Estimated Expiration: See Plans and Pricing

Patent: 37086
Estimated Expiration: See Plans and Pricing

Patent: 15518885
Estimated Expiration: See Plans and Pricing

Patent: 18012710
Estimated Expiration: See Plans and Pricing

Patent: 18048182
Estimated Expiration: See Plans and Pricing

Patent: 18507200
Estimated Expiration: See Plans and Pricing

Patent: 19203008
Estimated Expiration: See Plans and Pricing

Patent: 20015744
Estimated Expiration: See Plans and Pricing

Patent: 21183617
Estimated Expiration: See Plans and Pricing

Patent: 21193095
Estimated Expiration: See Plans and Pricing

Jordan

Patent: 0200222
Estimated Expiration: See Plans and Pricing

Patent: 54
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 7999
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 8290
Estimated Expiration: See Plans and Pricing

Patent: 14014848
Estimated Expiration: See Plans and Pricing

Patent: 17011270
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 711
Estimated Expiration: See Plans and Pricing

Patent: 643
Estimated Expiration: See Plans and Pricing

Patent: 654
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2548
Estimated Expiration: See Plans and Pricing

Patent: 3828
Estimated Expiration: See Plans and Pricing

Patent: 1932
Estimated Expiration: See Plans and Pricing

Patent: 7725
Estimated Expiration: See Plans and Pricing

Peru

Patent: 150174
Estimated Expiration: See Plans and Pricing

Patent: 190390
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 014502681
Estimated Expiration: See Plans and Pricing

Patent: 020500028
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 17133990
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 202101389T
Estimated Expiration: See Plans and Pricing

Patent: 202102078V
Estimated Expiration: See Plans and Pricing

Patent: 201408067Y
Estimated Expiration: See Plans and Pricing

Patent: 201707122Q
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 150015021
Estimated Expiration: See Plans and Pricing

Patent: 170091785
Estimated Expiration: See Plans and Pricing

Patent: 170122220
Estimated Expiration: See Plans and Pricing

Patent: 190040370
Estimated Expiration: See Plans and Pricing

Patent: 200017549
Estimated Expiration: See Plans and Pricing

Patent: 210033067
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 32912
Estimated Expiration: See Plans and Pricing

Patent: 53041
Estimated Expiration: See Plans and Pricing

Patent: 62963
Estimated Expiration: See Plans and Pricing

Patent: 62964
Estimated Expiration: See Plans and Pricing

Patent: 33027
Estimated Expiration: See Plans and Pricing

Patent: 1402122
Estimated Expiration: See Plans and Pricing

Patent: 1636023
Estimated Expiration: See Plans and Pricing

Patent: 1811334
Estimated Expiration: See Plans and Pricing

Patent: 1902483
Estimated Expiration: See Plans and Pricing

Patent: 1906612
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 14000492
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 4421
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 848
Estimated Expiration: See Plans and Pricing

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
Uruguay 34848 FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON See Plans and Pricing
Hong Kong 1140107 INHIBITORS OF BRUTON'S TYROSINE KINASE BRUTON See Plans and Pricing
Canada 2874756 INHIBITEURS DE LA TYROSINE KINASE DE BRUTON (INHIBITORS OF BRUTON'S TYROSINE KINASE) See Plans and Pricing
Hong Kong 1249015 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) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMBRUVICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 LUC00011 Luxembourg See Plans and Pricing PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 20150707
2201840 122015000027 Germany See Plans and Pricing PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 CR 2015 00021 Denmark See Plans and Pricing PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
Moodys
Medtronic
McKesson
McKinsey

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.