IMBRUVICA Drug Patent Profile

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

Summary for IMBRUVICA

International Patents:	428
US Patents:	55
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	151
Patent Applications:	4,055
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

See drug prices 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-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					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No
Pharmacyclics Llc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No					Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No					Y

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

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

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Eurasian Patent Organization

European Patent Office

Guatemala

Hong Kong

Israel

Japan

Jordan

Malaysia

Mexico

Morocco

New Zealand

Peru

Philippines

Russian Federation

Singapore

South Africa

South Korea

Taiwan

Tunisia

Ukraine

Uruguay

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
Japan	2018507200	ブルトン型チロシンキナーゼ阻害剤の薬学的製剤
Hungary	E036897
Australia	2022201742	The use of inhibitors of Bruton's tyrosine kinase (Btk)
Canada	2875986	FORMES CRISTALLINES D'UN INHIBITEUR DE TYROSINE KINASE DE BRUTON (CRYSTALLINE FORMS OF A BRUTON'S TYROSINE KINASE INHIBITOR)
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))
Russian Federation	2017133990	ФАРМАЦЕВТИЧЕСКИЕ ЛЕКАРСТВЕННЫЕ ФОРМЫ ИНГИБИТОРА ТИРОЗИНКИНАЗЫ БРУТОНА

Supplementary Protection Certificates for IMBRUVICA

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

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