You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: June 20, 2025

IMBRUVICA Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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-five patents protecting this drug and four Paragraph IV challenges.

This drug has four hundred and twenty-eight patent family members in forty-nine 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

< Available with Subscription >

  Try for Free

AI Research Assistant
Questions you can ask:
  • What is the 5 year forecast for IMBRUVICA?
  • What are the global sales for IMBRUVICA?
  • What is Average Wholesale Price for IMBRUVICA?
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
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-six US patents and eight FDA Regulatory Exclusivities.

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 ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 DISCN Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Pharmacyclics Llc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>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
Estimated Expiration: ⤷  Try for Free

Patent: 3832
Patent: FORMULACIONES FARMACÉUTICAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 8108
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Australia

Patent: 13271918
Patent: Crystalline forms of a bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 16226279
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibtor
Estimated Expiration: ⤷  Try for Free

Patent: 16250445
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 18211201
Estimated Expiration: ⤷  Try for Free

Patent: 18211216
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 20239751
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 21240244
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 23200435
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 23202671
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Brazil

Patent: 2014030424
Patent: formas cristalinas de um inibidor de quinase de tirosina de bruton
Estimated Expiration: ⤷  Try for Free

Patent: 2017018931
Patent: formulações farmacêuticas de um inibidor de tirosina quinase de bruton
Estimated Expiration: ⤷  Try for Free

Canada

Patent: 75986
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 76695
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 91994
Patent: FORMULATION PHARMACEUTIQUE POUR ADMINISTRATION ORALE COMPRENANT DE L'IBRUTINIB (PHARMACEUTICAL FORMULATION FOR ORAL ADMINISTRATION COMPRISING IBRUTINIB)
Estimated Expiration: ⤷  Try for Free

Patent: 15208
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 77990
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 77995
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 18491
Patent: FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Chile

Patent: 14003306
Patent: Preparacion farmaceutica oral que comprende un inhibidor de tirosina quinasa de bruton y forma cristalina a del mismo.
Estimated Expiration: ⤷  Try for Free

Patent: 17000371
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton
Estimated Expiration: ⤷  Try for Free

Patent: 17003496
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton.
Estimated Expiration: ⤷  Try for Free

China

Patent: 4736178
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

Colombia

Patent: 40408
Patent: Formas cristalinas de un inhibidor de tirosina quinasa de bruton
Estimated Expiration: ⤷  Try for Free

Costa Rica

Patent: 140558
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Dominican Republic

Patent: 014000274
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 017000152
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 022000096
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Ecuador

Patent: 14033163
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 19015794
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Eurasian Patent Organization

Patent: 1492082
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

Patent: 65084
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR)
Estimated Expiration: ⤷  Try for Free

Guatemala

Patent: 1400281
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

Israel

Patent: 5894
Patent: צורות גבישיות של מעכב ברוטון טירוסין קינאז (Crystalline forms of a bruton's tyrosine kinase inhibitor)
Estimated Expiration: ⤷  Try for Free

Patent: 3995
Patent: פורמולציות רוקחיות של מעכב ברוטון טירוסין קינאז (Pharmaceutical formulations of bruton's tyrosine kinase inhibitor)
Estimated Expiration: ⤷  Try for Free

Patent: 2367
Patent: צורות גבישיות של מעכב ברוטון טירוסין קינאז (Crystalline forms of a bruton's tyrosine kinase inhibitor)
Estimated Expiration: ⤷  Try for Free

Patent: 3284
Patent: פורמולציות רוקחיות של מעכב ברוטון טירוסין קינאז (Pharmaceutical formulations of bruton's tyrosine kinase inhibitor)
Estimated Expiration: ⤷  Try for Free

Japan

Patent: 36071
Estimated Expiration: ⤷  Try for Free

Patent: 37086
Estimated Expiration: ⤷  Try for Free

Patent: 49076
Estimated Expiration: ⤷  Try for Free

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: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

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
Estimated Expiration: ⤷  Try for Free

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)
Estimated Expiration: ⤷  Try for Free

Jordan

Patent: 0200222
Patent: أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون (CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 54
Patent: أشكال كريستالين لمثبط أنزيم كيناز تيروسين بروتون (CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Malaysia

Patent: 7999
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 4911
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Mexico

Patent: 8290
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 14014848
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 17011270
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 21012478
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON. (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 21015368
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 21015370
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 21015405
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
Estimated Expiration: ⤷  Try for Free

Patent: 21015408
Patent: COMPOSICIONES FARMACEUTICAS DE UN INHIBIDOR DE TIROSINA CINASA DE BRUTON. (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR.)
Estimated Expiration: ⤷  Try for Free

Morocco

Patent: 711
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
Estimated Expiration: ⤷  Try for Free

Patent: 643
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 654
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
Estimated Expiration: ⤷  Try for Free

New Zealand

Patent: 2548
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 3828
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 1932
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 4446
Patent: Pharmaceutical formulations of bruton’s tyrosine kinase inhibtor
Estimated Expiration: ⤷  Try for Free

Patent: 7725
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Peru

Patent: 150174
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 190390
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Philippines

Patent: 014502681
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 020500028
Patent: CRYSTALLINE FORMS OF A BRUTON`S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Russian Federation

Patent: 17133990
Patent: ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА
Estimated Expiration: ⤷  Try for Free

Singapore

Patent: 202101389T
Patent: CRYSTALLINE FORMS OF A BRUTON’S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 202102078V
Patent: PHARMACEUTICAL FORMULATIONS OF A BRUTON’S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 201408067Y
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 201707122Q
Patent: PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR
Estimated Expiration: ⤷  Try for Free

South Africa

Patent: 1907661
Patent: PHARMACEUTICAL FORMULATIONS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 2105174
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 2105175
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 2303227
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

South Korea

Patent: 150015021
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Patent: 170091785
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 170122220
Patent: 브루톤 타이로신 키나제 저해제의 약제학적 제제
Estimated Expiration: ⤷  Try for Free

Patent: 190040370
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 200017549
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 210033067
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 220093389
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 230170108
Patent: 브루톤 타이로신 키나아제 저해제의 결정 형태 (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Taiwan

Patent: 32912
Estimated Expiration: ⤷  Try for Free

Patent: 53041
Estimated Expiration: ⤷  Try for Free

Patent: 62963
Estimated Expiration: ⤷  Try for Free

Patent: 62964
Estimated Expiration: ⤷  Try for Free

Patent: 33027
Estimated Expiration: ⤷  Try for Free

Patent: 10588
Estimated Expiration: ⤷  Try for Free

Patent: 1402122
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 1636023
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 1811334
Patent: Crystalline forms of a bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 1902483
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 1906612
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 2211924
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Patent: 2315634
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
Estimated Expiration: ⤷  Try for Free

Tunisia

Patent: 14000492
Patent: CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR
Estimated Expiration: ⤷  Try for Free

Ukraine

Patent: 4421
Patent: КРИСТАЛІЧНА ФОРМА ІНГІБІТОРУ ТИРОЗИНКІНАЗИ БРУТОНА (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
Estimated Expiration: ⤷  Try for Free

Patent: 6959
Patent: ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР ТИРОЗИНКІНАЗИ БРУТОНА
Estimated Expiration: ⤷  Try for Free

Uruguay

Patent: 848
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

Patent: 740
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷  Try for Free

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
Hungary S1500018 ⤷  Try for Free
Japan 2018507200 ブルトン型チロシンキナーゼ阻害剤の薬学的製剤 ⤷  Try for Free
Hungary E036897 ⤷  Try for Free
Australia 2022201742 The use of inhibitors of Bruton's tyrosine kinase (Btk) ⤷  Try for Free
Canada 2875986 FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR) ⤷  Try for Free
Japan 2016065078 ブルトン型チロシンキナーゼ(Btk)の阻害剤の使用 (THE USE OF INHIBITOR OF BRUTON'S TYROSINE KINASE (BTK)) ⤷  Try for Free
Russian Federation 2017133990 ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА ⤷  Try for Free
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IMBRUVICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2201840 15C0029 France ⤷  Try for Free PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023
2201840 300728 Netherlands ⤷  Try for Free DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2201840 C20150014 00145 Estonia ⤷  Try for Free PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2529621 132017000036530 Italy ⤷  Try for Free PRODUCT NAME: IBRUTINIB O SUO SALE FARMACEUTICAMENTE ACCETTABILE(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/4/945, 20150707
2526934 93321 Luxembourg ⤷  Try for Free PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
2201840 PA2015017 Lithuania ⤷  Try for Free PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 601 Finland ⤷  Try for Free
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for Imbruvica

Introduction

Imbruvica, a breakthrough drug developed by AbbVie and Janssen, has been a cornerstone in the treatment of various types of blood cancers, including mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL). Here, we delve into the market dynamics and financial trajectory of Imbruvica, highlighting its current market size, growth prospects, regional performance, and the factors driving its success.

Global Market Size and Growth Prospects

As of 2024, the global Imbruvica market size is estimated to be USD 9,698.2 million. This market is projected to grow at a compound annual growth rate (CAGR) of 24.3% from 2024 to 2031, reaching a staggering USD 44,462 million by 2031[1].

Regional Performance

North America

North America dominates the Imbruvica market, accounting for over 40% of the global revenue. In 2024, the North American market size was USD 3,879.28 million, with the United States being the largest contributor at USD 3,060.75 million. This region is expected to grow at a CAGR of 22.5% from 2024 to 2031, driven by high healthcare spending, favorable reimbursement practices, and strong support for advanced cancer treatments[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market for Imbruvica, with a market size of USD 2,230.59 million in 2024. This region is anticipated to grow at a CAGR of 26.3% from 2024 to 2031. Countries like India and China are significant contributors due to their emerging healthcare infrastructure and manufacturing capabilities[1].

Latin America and Middle East & Africa

Latin America holds around 5% of the global revenue, with a market size of USD 484.91 million in 2024, expected to grow at a CAGR of 23.7%. The Middle East and Africa account for about 2% of the global revenue, with a market size of USD 193.96 million in 2024, projected to grow at a CAGR of 24.0% from 2024 to 2031[1].

Drivers of Market Growth

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as cancer, diabetes, and cardiovascular diseases (CVDs), coupled with the adoption of sedentary lifestyles and increasing obesity rates, is a significant driver of the Imbruvica market[1][4].

Technological Advancements and Targeted Therapies

Advancements in targeted medicines and the increasing acceptance of these therapies are crucial factors driving the growth of the Imbruvica market. The approval of Imbruvica for various cancer indications, such as CLL/SLL, further boosts its market potential[4].

Healthcare Infrastructure and Reimbursement

Improving healthcare infrastructure and favorable reimbursement scenarios in many regions are also key drivers. For instance, the FDA's approval of Imbruvica in combination with obinutuzumab for CLL/SLL treatment has enhanced its market position[4].

Financial Performance

Historical Revenue

Imbruvica's U.S. net revenue has seen significant growth since its introduction. From $492 million in 2014, it increased to $4.3 billion in 2020. Globally, AbbVie and Janssen have collected over $16 billion in U.S. net revenue from Imbruvica since its launch[3].

Recent Financials

In the third quarter of 2024, global Imbruvica net revenues were $828 million, a decrease of 8.8% compared to the previous year, with U.S. net revenues of $618 million and international revenues of $210 million[5].

Challenges and Limitations

High Development Costs

The significant costs associated with the development of biologic medications like Imbruvica can limit market expansion. These costs include extensive R&D, clinical trials, and regulatory approvals[4].

Adverse Effects and High Drug Costs

The high cost of Imbruvica and its potential adverse effects are other challenges that could stifle market growth. For example, the annual net price of Imbruvica increased from $72,587 in 2013 to $115,533 in 2017, making it a costly treatment option for many patients[3].

Future Outlook

Emerging Markets

Emerging economies, particularly in the Asia-Pacific region, are expected to play a significant role in the future growth of the Imbruvica market. Countries like India, with their growing healthcare spending and indigenous R&D initiatives, will contribute substantially to this growth[1][4].

Regulatory Approvals and Clinical Studies

Ongoing clinical studies and regulatory approvals for new indications will continue to expand the commercial scope of Imbruvica. For instance, the European Commission's approval for Imbruvica in treating specific cancer illnesses will further drive its market growth[4].

Key Takeaways

  • Global Market Size: The global Imbruvica market size was estimated at USD 9,698.2 million in 2024.
  • Growth Prospects: Expected to grow at a CAGR of 24.3% from 2024 to 2031.
  • Regional Dominance: North America dominates the market, with the Asia Pacific region being the fastest-growing.
  • Drivers: Increasing prevalence of chronic diseases, technological advancements, and favorable reimbursement practices.
  • Challenges: High development costs, adverse effects, and high drug costs.
  • Future Outlook: Emerging markets and ongoing regulatory approvals will drive future growth.

FAQs

Q: What is the current global market size of Imbruvica?

The global Imbruvica market size was estimated at USD 9,698.2 million in 2024[1].

Q: What is the projected CAGR for the Imbruvica market from 2024 to 2031?

The Imbruvica market is expected to grow at a CAGR of 24.3% from 2024 to 2031[1].

Q: Which region dominates the Imbruvica market?

North America dominates the Imbruvica market, accounting for over 40% of the global revenue[1].

Q: What are the main drivers of the Imbruvica market growth?

The main drivers include the increasing prevalence of chronic diseases, technological advancements in targeted therapies, and favorable reimbursement practices[1][4].

Q: What are the significant challenges facing the Imbruvica market?

High development costs, potential adverse effects, and the high cost of the drug are significant challenges[3][4].

Sources

  1. Cognitive Market Research: Global Imbruvica Market Report 2024.
  2. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
  3. U.S. House of Representatives: Drug Pricing Investigation - Document Repository.
  4. GlobeNewswire: With 6.9% CAGR, Imbruvica Market Size to hit US $66.29 billion by 2030.
  5. AbbVie Investors: AbbVie Reports Third-Quarter 2024 Financial Results.
Last updated: 2024-12-16

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.