IBRUTINIB - Generic Drug Details

What are the generic drug sources for ibrutinib and what is the scope of freedom to operate?

Ibrutinib is the generic ingredient in two branded drugs marketed by Zydus Lifesciences and Pharmacyclics Llc, and is included in four NDAs. There are fifty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibrutinib has four hundred and one patent family members in forty-eight countries.

There are sixteen drug master file entries for ibrutinib. One supplier is listed for this compound. There are six tentative approvals for this compound.

Summary for IBRUTINIB

International Patents:	401
US Patents:	54
Tradenames:	2
Applicants:	2
NDAs:	4
Drug Master File Entries:	16
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	99
Clinical Trials:	356
Patent Applications:	6,199
Drug Prices:	Drug price trends for IBRUTINIB
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IBRUTINIB
What excipients (inactive ingredients) are in IBRUTINIB?	IBRUTINIB excipients list
DailyMed Link:	IBRUTINIB at DailyMed

See drug prices for IBRUTINIB

Recent Clinical Trials for IBRUTINIB

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

Sponsor	Phase
Janssen Inc.	Phase 2
Merck Sharp & Dohme LLC	Phase 3
Assistance Publique - Hôpitaux de Paris	Phase 2

See all IBRUTINIB clinical trials

Generic filers with tentative approvals for IBRUTINIB

Applicant	Application No.	Strength	Dosage Form
		140MG	CAPSULE;ORAL
		140MG	CAPSULE;ORAL
		560MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for IBRUTINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for IBRUTINIB

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for IBRUTINIB

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 IBRUTINIB

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

EU/EMA Drug Approvals for IBRUTINIB

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 IBRUTINIB

Country	Patent Number	Title	Estimated Expiration
Australia	2022201742
Japan	2010504324
Canada	3143428	8-AMINO-3-SUBSTITUTE-IMIDAZO[1,5-A]PYRAZINE ET UTILISATION CONNEXE COMME INHIBITEURS DE TYROSINE KINASE DE BRUTON (8-AMINO-3-SUBSTITUTED-IMIDAZO[1,5-A]PYRAZINE AND USE THEREOF AS INHIBITORS OF BRUTON'S TYROSINE KINASE)
Australia	2020204270
Hong Kong	1208803
Finland	3265084
Mexico	2009010284	INHIBIDORES DE LA TIROSINA-CINASA DE BRUTON. (INHIBITORS OF BRUTON'S TYROSINE KINASE.)

Supplementary Protection Certificates for IBRUTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201840	CR 2015 00021	Denmark		PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
2201840	18/2015	Austria		PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2526934	PA2016034	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2526934	132016000119245	Italy		PRODUCT NAME: IBRUTINIB O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE PER IL TRATTAMENTO DI PAZIENTI ADULTI CON LEUCEMIA LINFOCITICA CRONICA (CLL) PRECEDENTEMENTE NON TRATTATA(IMBRUVICA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/945, 20160530
2526934	300844	Netherlands		PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2529621	CA 2017 00012	Denmark		PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
2201840	PA2015017	Lithuania		PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021

IBRUTINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ibrutinib

Market Overview

Ibrutinib, marketed under the brand name Imbruvica, is a kinase inhibitor that targets Bruton's tyrosine kinase (BTK), a protein crucial for the proliferation of certain cancer cells. It is primarily used to treat various blood malignancies, including chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL)[1][2][3].

Market Size and Growth

The ibrutinib market has been experiencing significant growth and is projected to continue this trend. As of 2023, the market size was valued at approximately $14.87 billion and is expected to grow to $18.29 billion in 2024, with a compound annual growth rate (CAGR) of 23.0%[2].

By 2028, the market is forecasted to reach $41.98 billion, maintaining a CAGR of 23.1%[2]. Long-term projections indicate that the market could reach $61.88 billion by 2030, with a CAGR of 23.10% from 2024 to 2030[3].

Key Drivers of the Market

Several factors are driving the growth of the ibrutinib market:

• Increasing Incidence of Blood Cancers: The rising number of cancer patients globally, particularly those with CLL, MCL, and other lymphomas, is a significant driver. For instance, in 2022, about 60,650 new cases of leukemia were diagnosed in the United States alone[3].
• Expanding Approvals and Indications: Continuous regulatory approvals for new indications and geographic areas are boosting market growth. For example, Johnson & Johnson's submission for a new indication for Imbruvica in combination with bendamustine and rituximab for untreated MCL patients is a recent development[3].
• Advancements in Healthcare Infrastructure: Improvements in healthcare facilities, especially in regions like Asia-Pacific, are enhancing access to innovative treatments. Countries such as China, Japan, and India are seeing significant growth due to these improvements[1][3].
• Favorable Reimbursement Policies: Beneficial reimbursement practices and early adoption of innovative therapies in regions like North America are also driving market expansion[1][3].

Regional Market Analysis

North America

North America dominates the ibrutinib market, accounting for more than 49% of the global market share. The region's high healthcare costs, sophisticated infrastructure, and sizable patient base contribute to its leading position. The United States and Canada are key drivers, with favorable reimbursement rules and early uptake of new therapies[1][3].

Europe

Europe is the second-largest region in the ibrutinib market, driven by well-established healthcare systems, increasing cancer awareness, and regulatory approvals. Countries like Germany, France, and the UK benefit from a growing elderly population and access to innovative treatments[1].

Asia-Pacific

The Asia-Pacific region is expected to be the fastest-growing segment during the forecast period. Countries such as China, Japan, and India are driving this growth due to improvements in healthcare facilities, expanding disposable incomes, and increasing R&D spending[1][3].

Market Restraints

Despite the positive growth trajectory, there are several restraints to consider:

• Side Effects: Ibrutinib can cause significant side effects such as high blood pressure and diarrhea, which may limit its adoption[3].
• High Development Costs: The substantial costs associated with the development of biologic medications like ibrutinib can hinder market expansion[5].

Competitive Landscape

The ibrutinib market is dominated by a few major players, including:

• Janssen Pharmaceuticals: A subsidiary of Johnson & Johnson, which markets Imbruvica.
• Beacon Pharmaceuticals
• Incepta Pharmaceuticals
• Bluepharma
• Other players: Such as Pfizer, which is involved in the development of generic drugs for cancer treatment[1][3].

Financial Performance

The financial performance of ibrutinib, particularly under the brand name Imbruvica, has been significant. In 2023, global Imbruvica net revenues were $903 million, although this represented a 19.0% decrease from the previous year. The U.S. net revenues were $683 million, with international revenues contributing $220 million[4].

Future Trends and Opportunities

Expanded Indications and Clinical Trials

Potential label expansions and ongoing clinical trials are expected to drive future growth. For instance, the combination of ibrutinib with other therapies for new indications is being explored[2][3].

Biosimilars and Generics

The development of biosimilars and generics could impact the market, but it also presents opportunities for market players to expand their offerings[2][3].

Health Technology Assessment and Market Access

Real-world evidence and long-term safety profiles will become increasingly important for market access and reimbursement decisions[2].

Immunotherapy and Radiotherapy

Increased R&D activities in immunotherapy and radiotherapy using inhibition techniques to stop excessive cell growth are expected to create growth opportunities[3].

Key Takeaways

• The ibrutinib market is projected to grow significantly, driven by increasing cancer incidence, expanding approvals, and advancements in healthcare infrastructure.
• North America and Europe are the leading regions, with Asia-Pacific expected to be the fastest-growing segment.
• Major players like Janssen Pharmaceuticals and others dominate the market.
• Despite side effects and high development costs, the market is expected to expand due to favorable reimbursement policies and ongoing R&D.

FAQs

What is ibrutinib used for?

Ibrutinib is used to treat various blood malignancies, including chronic lymphocytic leukemia (CLL), Waldenström macroglobulinemia, mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL)[1][2][3].

What is the current market size of ibrutinib?

As of 2023, the ibrutinib market size was valued at approximately $14.87 billion[2].

What is the projected growth rate of the ibrutinib market?

The ibrutinib market is expected to grow at a CAGR of 23.1% from 2023 to 2028 and reach $41.98 billion by 2028[2].

Which regions dominate the ibrutinib market?

North America dominates the market, followed by Europe, with the Asia-Pacific region expected to be the fastest-growing segment[1][3].

What are the major restraints to the ibrutinib market?

Significant side effects such as high blood pressure and diarrhea, along with the high costs associated with biologic medication development, are major restraints[3][5].

Cited Sources:

1. We Market Research: Ibrutinib Market Insights, Segmentation, Statistics and Forecast to 2034.
2. The Business Research Company: Ibrutinib Global Market Report 2024.
3. Next MSC: Ibrutinib Market Size and Share | Statistics – 2030.
4. AbbVie Investors: AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results.
5. GlobeNewswire: With 6.9% CAGR, Imbruvica Market Size to hit US $66.29 billion by 2030.