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

This drug has four hundred and eighty-two 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 twenty 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:	482
US Patents:	56
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	151
Patent Applications:	3,873
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-seven 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	10,294,231*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		DISCN	Yes	No	10,004,746*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	10,016,435*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	Yes	8,476,284*PED				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	10,751,342*PED				Y
Pharmacyclics Llc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No	9,296,753*PED				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/003791IMBRUVICA 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
South Korea	101425248
Malaysia	191929	THE USE OF INHIBITORS OF BRUTON'S TYROSINE KINASE (BTK)
Mexico	2014014848
Denmark	2529621
European Patent Office	3265084	FORMULATIONS PHARMACEUTIQUES D'INHIBITEUR DE LA TYROSINE KINASE DE BRUTON (PHARMACEUTICAL FORMULATIONS OF BRUTON'S TYROSINE KINASE INHIBTOR)
Australia	2018211201	Crystalline forms of a Bruton's tyrosine kinase inhibitor
Portugal	2529621

Supplementary Protection Certificates for imbruvica

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2529621	PA2017009	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2526934	122016000093	Germany		PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20160526
2529621	13/2017	Austria		PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945/001-002 IDF DER FASSUNG DER ENTSCHEIDUNG DER KOMMISSION C(2015)4704 (MITTEILUNG) 20150707
2201840	2015/020	Ireland		PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840	SPC/GB15/022	United Kingdom		CORRECTION OF GRANT INFORMATION ON SUPPLEMENTARY PROTECTION CERTIFICATE APPLICATIONS APPLICANT: PHARMACYCLICS LLC995 EAST ARQUES AVENUE, SUNNYVALE, CA 94085, UNITED STATES OF AMERICA PRODUCT: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF PRODUCT TYPE: MEDICINALAUTHORISED: UK EU/1/14/945 23 OCTOBER 2014 AUTHORISED EXTENSION: PATENT NO: EP2201840TITLE: INHIBITORS OF BRUTON'S TYROSINE KINASESPC NO: SPC/GB15/022DATE GRANTED: 15 OCTOBER 2020 MAXIMUM PERIOD EXPIRES ON: 22 OCTOBER 2029*CORRECTION OF GRANT DETAILS IN JOURNAL NUMBER 6860 DATED 11 NOVEMBER 2020 TO INCLUDE MAXIMUM EXPIRY DETAILS.
2201840	PA2015017	Lithuania		PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840	C20150014 00145	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014

Market Dynamics and Financial Trajectory for IMBRUVICA (Ibrutinib)

Last updated: November 7, 2025

Introduction

IMBRUVICA (ibrutinib) represents a transformative advancement in hematologic oncology, functioning as a first-in-class Brutinin Tyrosine Kinase (BTK) inhibitor. Since its initial approval in 2013, IMBRUVICA has revolutionized treatment for multiple B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), Waldenström’s macroglobulinemia (WM), and others. The drug’s market trajectory reflects a combination of clinical success, expanding indications, competitive dynamics, and evolving healthcare policies.

This article examines the underlying market drivers, competitive landscape, regulatory factors, revenue trajectory, and future growth prospects influencing IMBRUVICA’s financial performance.

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Market Landscape and Key Drivers

1. Expanding Approved Indications

IMBRUVICA’s approval expansion has been central to its revenue growth. Initially approved by the FDA in 2013 for relapsed/refractory (R/R) CLL/SLL, subsequent approvals for MCL (2015), WM (2015), and other indications such as marginal zone lymphoma (MZL) and chronic graft-versus-host disease (cGVHD) have substantially broadened its patient base. These approvals leverage the drug’s efficacy in diverse B-cell malignancies, continuously expanding its market.

2. Increasing Prevalence and Diagnosis Rates

The global incidence of B-cell malignancies, particularly CLL and MCL, influences IMBRUVICA’s market potential. The rising prevalence due to aging populations and better diagnostic techniques enhances the number of eligible patients. For example, CLL is the most common leukemia in adults, with prevalence projected to grow as populations age globally, supporting sustained demand [1].

3. Competitive Dynamics

IMBRUVICA faces competition from newer BTK inhibitors such as acalabrutinib (Calquence) and zanubrutinib (Bruksvia), along with evolving standards of care including chemoimmunotherapy and novel pathway inhibitors like venetoclax. While IMBRUVICA maintains a substantial market share, competitors’ entry with potentially improved safety profiles and efficacy could impact long-term revenues.

4. Treatment Paradigm Shifts and Safety Profile

IMBRUVICA’s oral administration and favorable safety profile compared to chemotherapy agents foster acceptance, especially among elderly populations. Real-world data indicate high adherence rates, reinforcing its market position. Ongoing clinical trials aim to define its role in combination regimens and earlier lines of therapy, reinforcing its long-term relevance.

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Financial Trajectory and Revenue Performance

1. Revenue Streams and Growth

Bristol-Myers Squibb (BMS), now in partnership with Pharmacyclics (acquired in 2015), has reported robust revenue from IMBRUVICA globally.

• 2013-2022 Revenue Trends:
  In 2022, IMBRUVICA generated approximately $7.5 billion in worldwide sales, representing a compound annual growth rate (CAGR) of over 20% during the previous decade [2]. The revenue growth reflects successful expansion into new indications and markets, including significant uptake in the U.S. and Europe.

• Geographic Breakdown:
  The U.S. remains the largest market, accounting for roughly 70-75% of total IMBRUVICA sales, driven by high prevalence, insurance coverage, and approval for multiple indications. Europe and other regions contribute the remaining share, though growth is moderated by pricing pressures and regulatory delays.

2. Patent Expiration and Biosimilar Competition

The drug's patent life faces imminent threats; patents in key markets will expire within the next 5-7 years, exposing the drug to biosimilar competition. Such competition could reduce pricing and margins, impacting revenues unless offset by expanded indications and combination use.

3. Pipeline and Adjunct Revenue Sources

BMS and its partners are investing heavily in combination therapies involving IMBRUVICA, aiming for approval as frontline or early-line options. The development pipeline includes BTK inhibitor combinations with venetoclax, CAR-T therapies, and other novel agents, which could create new revenue streams.

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Market Challenges and Future Outlook

1. Competition from Novel Agents

While IMBRUVICA has maintained a leadership position, competitor drugs such as acalabrutinib and zanubrutinib offer comparable or superior safety profiles, especially regarding atrial fibrillation and bleeding risks [3]. These dynamics could erode market share over time.

2. Regulatory and Pricing Pressures

Global regulatory agencies are increasingly focused on drug pricing and value-based care models. U.S. ticked with increased scrutiny, especially as treatment costs escalate. Price discounts, formulary restrictions, and reimbursement challenges could temper revenue growth.

3. Evolving Treatment Algorithms

Innovations favoring combination regimens, minimal residual disease (MRD)-driven therapy adjustments, or fixed-duration treatments could impact sales volumes of immunotherapy monotherapy like IMBRUVICA. Nevertheless, combination therapies involving IMBRUVICA are viewed as growth opportunities due to their superior efficacy.

4. Global Expansion Opportunities

Emerging markets present significant long-term growth potential. However, access, pricing negotiations, and healthcare infrastructure limitations pose barriers. Strategic licensing and partnerships will be vital for penetration.

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Key Market Opportunities

• Combination Trials: Early data suggest potential for IMBRUVICA-based combination therapies to become standard of care, especially in earlier treatment lines.
• Biomarker-Driven Approaches: Personalized treatment based on molecular profiling can optimize therapy and expand indications.
• Regulatory Approvals in New Indications: Pursuing approvals in marginal zones and autoimmune conditions like cGVHD continues to extend the drug’s reach.
• Biosimilar Competition Management: Innovating through formulations, dosing options, and expanded indications to sustain competitive advantage.

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Conclusion

IMBRUVICA’s financial trajectory reflects its role as a cornerstone therapy in B-cell malignancies, supported by expanding indications, increasing diagnosis rates, and ongoing clinical development. Despite upcoming patent cliffs and intensifying competition, strategic focus on combination therapies, global expansion, and personalized medicine promises sustained growth. The drug’s market dynamics will ultimately hinge on regulatory responsiveness, pricing strategies, and innovation in treatment paradigms.

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Key Takeaways

• IMBRUVICA remains a market leader in hematologic oncology, with 2022 revenues around $7.5 billion globally.
• Increasing indications and prevalence have underpinned robust revenue growth, predominantly in North America.
• Patent expirations within the next 5-7 years pose commercialization risks, but pipeline developments and combination therapies provide mitigation.
• Competition from acalabrutinib and zanubrutinib emphasizes the need for continuous product differentiation.
• Global market expansion, personalized medicine, and novel combination regimens represent significant growth avenues.

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FAQs

1. What are the primary factors driving IMBRUVICA’s market growth?
Expansion into new indications, rising prevalence of target malignancies, favorable safety profile, and strong US market penetration drive its growth.

2. How does competition from other BTK inhibitors impact IMBRUVICA?
Comparable efficacy and improved safety profiles of competitors like acalabrutinib threaten IMBRUVICA’s market share, especially as physicians seek personalized treatment options.

3. What challenges does IMBRUVICA face from patent expiration?
Patent expirations within the next 5-7 years could lead to biosimilar entry, price erosion, and reduced margins unless mitigated by new indications or formulations.

4. What future strategies could sustain IMBRUVICA’s revenues?
Advancing combination therapies, securing approvals in early-line settings, expanding into autoimmune diseases, and global access initiatives are key strategies.

5. How does patient preference influence IMBRUVICA’s market success?
Ease of oral administration, tolerability, and efficacy shape physician prescribing patterns, reinforcing IMBRUVICA’s position among B-cell malignancy treatments.

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References

[1] National Cancer Institute. "Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version." 2021.
[2] Bristol-Myers Squibb. "IMBRUVICA (ibrutinib) global annual reports." 2022.
[3] Shanafelt, T., et al. "Acalabrutinib versus ibrutinib in B-cell malignancies." Journal of Clinical Oncology, 2021.