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 four hundred and one patent family members in forty-eight 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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Summary for IMBRUVICA

International Patents:	401
US Patents:	54
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	151
Patent Applications:	3,121
Drug Prices:	Drug price information for IMBRUVICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMBRUVICA
What excipients (inactive ingredients) are in IMBRUVICA?	IMBRUVICA excipients list
DailyMed Link:	IMBRUVICA at DailyMed

Drug patent expirations by year for IMBRUVICA

Recent Clinical Trials for IMBRUVICA

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

Sponsor	Phase
Peter MacCallum Cancer Centre, Australia	Phase 2
Oncternal Therapeutics, Inc	Phase 3
Academic and Community Cancer Research United	Phase 2

See all IMBRUVICA clinical trials

Pharmacology for IMBRUVICA

Drug Class	Kinase 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	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 nine FDA Regulatory Exclusivities.

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Glossary

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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	8,999,999*PED	⤷ Subscribe			Y	⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No	9,801,883*PED	⤷ Subscribe			Y	⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	SUSPENSION;ORAL	217003-001	Aug 24, 2022		RX	Yes	Yes	8,999,999	⤷ Subscribe				⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	8,008,309*PED	⤷ Subscribe			Y	⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No	10,294,232*PED	⤷ Subscribe			Y	⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	9,795,604*PED	⤷ Subscribe			Y	⤷ Subscribe
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	10,010,507*PED	⤷ Subscribe			Y	⤷ Subscribe
>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

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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: ⤷ Subscribe

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
Estimated Expiration: ⤷ Subscribe

Australia

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

Patent: 16226279
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibtor
Estimated Expiration: ⤷ Subscribe

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

Patent: 18211201
Patent: Crystalline forms of a Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷ Subscribe

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

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

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
Estimated Expiration: ⤷ Subscribe

Patent: 23202671
Patent: Pharmaceutical formulations of Bruton's tyrosine kinase inhibitor
Estimated Expiration: ⤷ Subscribe

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
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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

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

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

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

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

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

Chile

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

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.
Estimated Expiration: ⤷ Subscribe

China

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

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: ⤷ Subscribe

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: ⤷ Subscribe

Colombia

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

Eurasian Patent Organization

Patent: 1492082
Patent: КРИСТАЛЛИЧЕСКИЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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

Guatemala

Patent: 1400281
Patent: FORMAS CRISTALINAS DE UN INHIBIDOR DE TIROSINA QUINASA DE BRUTON
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

Israel

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

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

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

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

Japan

Patent: 36071
Estimated Expiration: ⤷ Subscribe

Patent: 37086
Estimated Expiration: ⤷ Subscribe

Patent: 49076
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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: ⤷ Subscribe

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
Estimated Expiration: ⤷ Subscribe

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: ⤷ Subscribe

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)
Estimated Expiration: ⤷ Subscribe

Jordan

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

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

Malaysia

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

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

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: ⤷ Subscribe

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

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

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

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

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

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

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

Morocco

Patent: 711
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
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Patent: 643
Patent: FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON
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Patent: 654
Patent: Formes cristallines d'un inhibiteur de tyrosine kinase de bruton
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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
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Patent: 1932
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
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Patent: 4446
Patent: Pharmaceutical formulations of bruton’s tyrosine kinase inhibtor
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Patent: 7725
Patent: Crystalline forms of a bruton’s tyrosine kinase inhibitor
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Peru

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

Philippines

Patent: 014502681
Estimated Expiration: ⤷ Subscribe

Patent: 020500028
Estimated Expiration: ⤷ Subscribe

Russian Federation

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

Patent: 202101389T
Estimated Expiration: ⤷ Subscribe

Patent: 202102078V
Patent: PHARMACEUTICAL FORMULATIONS OF A BRUTON’S TYROSINE KINASE INHIBITOR
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Patent: 201408067Y
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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
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Patent: 2105175
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Patent: 2303227
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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)
Estimated Expiration: ⤷ Subscribe

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)
Estimated Expiration: ⤷ Subscribe

Taiwan

Patent: 32912
Estimated Expiration: ⤷ Subscribe

Patent: 53041
Estimated Expiration: ⤷ Subscribe

Patent: 62963
Estimated Expiration: ⤷ Subscribe

Patent: 62964
Estimated Expiration: ⤷ Subscribe

Patent: 33027
Estimated Expiration: ⤷ Subscribe

Patent: 10588
Estimated Expiration: ⤷ Subscribe

Patent: 1402122
Estimated Expiration: ⤷ Subscribe

Patent: 1636023
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Patent: 1811334
Estimated Expiration: ⤷ Subscribe

Patent: 1902483
Patent: Pharmaceutical formulations of a BRUTON'S tyrosine kinase inhibitor
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Patent: 1906612
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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
Estimated Expiration: ⤷ Subscribe

Ukraine

Patent: 4421
Estimated Expiration: ⤷ Subscribe

Patent: 6959
Estimated Expiration: ⤷ Subscribe

Uruguay

Patent: 848
Estimated Expiration: ⤷ Subscribe

Patent: 740
Estimated Expiration: ⤷ Subscribe

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IMBRUVICA around the world.

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Country	Patent Number	Title	Estimated Expiration
Mexico	2009003122	INHIBIDORES DE TIROSINA CINASA DE BRUTON. (INHIBITORS OF BRUTON'S TYROSINE KINASE.)	⤷ Subscribe
Ukraine	126959	ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ ІНГІБІТОР ТИРОЗИНКІНАЗИ БРУТОНА	⤷ Subscribe
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Supplementary Protection Certificates for IMBRUVICA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2526934	CA 2016 00056	Denmark	⤷ Subscribe	PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2526934	PA2016034	Lithuania	⤷ Subscribe	PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2201840	C20150014 00145	Estonia	⤷ Subscribe	PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2529621	122017000015	Germany	⤷ Subscribe	PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
2526934	300844	Netherlands	⤷ Subscribe	PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2529621	C20170010 00272	Estonia	⤷ Subscribe	PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2529621	PA2017009	Lithuania	⤷ Subscribe	PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
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IMBRUVICA Market Analysis and Financial Projection Experimental

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

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

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