ZANUBRUTINIB - Generic Drug Details

What are the generic sources for zanubrutinib and what is the scope of patent protection?

Zanubrutinib is the generic ingredient in one branded drug marketed by Beigene and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zanubrutinib has seventy-three patent family members in thirty countries.

One supplier is listed for this compound.

Summary for ZANUBRUTINIB

International Patents:	73
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	96
Patent Applications:	371
What excipients (inactive ingredients) are in ZANUBRUTINIB?	ZANUBRUTINIB excipients list
DailyMed Link:	ZANUBRUTINIB at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ZANUBRUTINIB

Constraining patent/regulatory exclusivity:

10,927,117

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ZANUBRUTINIB

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

Sponsor	Phase
University Health Network, Toronto	Phase 2
Incyte Corporation	Phase 1/Phase 2
Alvaro Alencar, MD	Phase 1/Phase 2

See all ZANUBRUTINIB clinical trials

Pharmacology for ZANUBRUTINIB

Drug Class	Kinase Inhibitor
Mechanism of Action	Bruton's Tyrosine Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ZANUBRUTINIB

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

Paragraph IV (Patent) Challenges for ZANUBRUTINIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
BRUKINSA	Capsules	zanubrutinib	80 mg	213217	2	2023-11-14

US Patents and Regulatory Information for ZANUBRUTINIB

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes	11,591,340
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes	11,970,500

EU/EMA Drug Approvals for ZANUBRUTINIB

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
BeiGene Ireland Ltd	Brukinsa	zanubrutinib	EMEA/H/C/004978 Brukinsa as monotherapy 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.Brukinsa as monotherapy is indicated for the treatment of adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy.Brukinsa as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL).	Authorised	no	no	no	2021-11-22

International Patents for ZANUBRUTINIB

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2989106	COMPOSÉS HÉTÉROCYCLIQUES FUSIONNÉS EN TANT QU'INHIBITEURS DE PROTÉINE KINASE (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS)
New Zealand	751418	Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Japan	7402685
South Korea	20230162137	(S)-7--4,5,6,7-테트라-하이드로피라졸로 [1,5-A] 피리미딘-3-카르복스아미드의 제조 및 그 용도 (S-7-1--4--2-4--4567-- [15-A] -3- S-7-1-Acryloylpiperidin-4-yl-2-4-Phenoxyphenyl-4567-tetra-Hydrazolo[15-a]Pyrimidine-3-Carboxamide Preparation and Uses Thereof)

Supplementary Protection Certificates for ZANUBRUTINIB

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2989106	CA 2022 00008	Denmark		PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123
2989106	SPC/GB22/006	United Kingdom		PRODUCT NAME: ZANUBRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1576 (NI) 20211122; UK FURTHER MA ON IPSUM 20211122
2989106	122022000013	Germany		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106	301161	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT

ZANUBRUTINIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Zanubrutinib

Introduction

Zanubrutinib, a Bruton's tyrosine kinase (BTK) inhibitor, has been making significant waves in the oncology treatment landscape, particularly in the management of B-cell malignancies. This article delves into the market dynamics and financial trajectory of zanubrutinib, highlighting its growth drivers, regional performance, and financial implications.

Mechanism and Therapeutic Potential

Zanubrutinib works by selectively inhibiting BTK, a crucial enzyme in the B-cell receptor signaling pathway. This targeted approach disrupts the signaling necessary for the growth and survival of malignant B-cells, leading to reduced proliferation and increased apoptosis of cancerous cells. This mechanism makes zanubrutinib an effective treatment for conditions such as chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL)[1].

Market Growth Drivers

The market for zanubrutinib is driven by several key factors:

Increasing Demand for Targeted Therapies

There is a growing preference for targeted therapies over traditional chemotherapy due to their specificity and reduced side effects. This shift is driving the demand for BTK inhibitors like zanubrutinib[1].

Advancements in Clinical Research

Ongoing clinical trials are exploring zanubrutinib's efficacy in combination therapies and its effectiveness in various patient populations. These studies are crucial for expanding its indications and optimizing treatment regimens[1].

Expanding Market Access

Zanubrutinib is gaining acceptance globally, with recent approvals and international regulatory clearances facilitating its entry into new markets. Strategic partnerships between pharmaceutical companies and research institutions are also enhancing its market access[1].

Regional Performance

North America

North America, particularly the U.S., remains a key market for zanubrutinib. The region's advanced healthcare infrastructure and high incidence rates of B-cell malignancies support the widespread adoption of this drug. In the first quarter of 2024, U.S. sales of BRUKINSA (zanubrutinib) totaled $351 million, representing a 153% growth over the prior-year period[3].

Europe

In Europe, zanubrutinib is gaining significant traction, driven by continued gains in market share and additional reimbursements. For instance, France implemented reimbursement for BRUKINSA within CLL, Waldenström’s macroglobulinemia (WM), and marginal zone lymphoma for the first time, contributing to a 243% growth in European sales in the first quarter of 2024[3].

Asia-Pacific

The Asia-Pacific region is witnessing a surge in demand for advanced oncology treatments, including zanubrutinib. Rapid economic growth, increasing healthcare investments, and rising awareness about cancer treatments are contributing to the expanding market in this region[1].

Financial Performance

Revenue Growth

BeiGene, the company behind BRUKINSA (zanubrutinib), reported significant revenue growth. In the third quarter of 2024, product revenue from BRUKINSA increased by 67% compared to the same period in 2023, reaching $993 million. This growth was primarily driven by increased sales in the U.S. and Europe[2].

Operating Expenses and Profitability

The company's operating expenses, including research and development and selling, general, and administrative expenses, increased in the third quarter of 2024. However, the operating loss decreased by 10% due to increased operating leverage. On an adjusted basis, BeiGene generated an operating income of $66 million, an increase of $82 million from the prior year period[2].

Gross Margin

The gross margin percentage for the third quarter of 2024 was 83% on a GAAP basis and 85% on an adjusted basis, reflecting a higher sales mix of BRUKINSA compared to other products in the portfolio[2].

Strategic Partnerships and Innovations

Collaborations and Research

Strategic partnerships between pharmaceutical companies and research institutions are driving innovation in the zanubrutinib market. These collaborations focus on enhancing drug formulations, exploring new indications, and expanding market access. For example, BeiGene's partnerships have been instrumental in accelerating the development and commercialization of BRUKINSA[1].

Innovations in Drug Delivery

Innovations in drug delivery systems and formulation improvements are also contributing to the effectiveness and patient adherence of zanubrutinib. These advancements are part of the broader effort to enhance the therapeutic potential of the drug[1].

Investment Opportunities

Biotechnology Sector

The surge in the zanubrutinib market presents substantial investment opportunities in the biotechnology sector. Investors are increasingly drawn to companies involved in developing and marketing targeted therapies like zanubrutinib. The focus on personalized medicine and targeted treatments makes zanubrutinib a compelling investment prospect[1].

Mergers and Acquisitions

The pharmaceutical sector is experiencing a wave of mergers and acquisitions, with several deals focused on oncology and targeted therapies. These strategic moves are aimed at consolidating resources, enhancing research capabilities, and accelerating the development of innovative treatments, including zanubrutinib[1].

Clinical Outcomes and Market Impact

Superior Long-Term Outcomes

Clinical trials have shown that zanubrutinib offers superior long-term outcomes compared to other BTK inhibitors like ibrutinib. For instance, the progression-free survival (PFS) rates at the 36-month mark stood at 64.9% for zanubrutinib versus 54.8% for ibrutinib[5].

Budget Impact Analysis

A budget impact model developed to estimate the economic impact of providing access to zanubrutinib within a hypothetical U.S. health plan indicated that the introduction of zanubrutinib could lead to significant changes in the treatment landscape for relapsed or refractory CLL patients. The model suggested that zanubrutinib could offer cost-effective treatment options while improving patient outcomes[4].

Key Takeaways

• Targeted Therapy: Zanubrutinib's targeted mechanism of action makes it a preferred treatment for B-cell malignancies.
• Regional Growth: The drug is experiencing significant growth in North America, Europe, and the Asia-Pacific region.
• Financial Performance: BeiGene's revenue from BRUKINSA has seen substantial growth, driven by increased sales and strategic partnerships.
• Investment Opportunities: The biotechnology sector, particularly companies involved in targeted therapies, presents promising investment opportunities.
• Clinical Outcomes: Zanubrutinib has demonstrated superior long-term outcomes compared to other BTK inhibitors.

FAQs

What is zanubrutinib and how does it work?

Zanubrutinib is a Bruton's tyrosine kinase (BTK) inhibitor that works by selectively targeting and inhibiting BTK, disrupting the signaling pathway critical for the growth and survival of malignant B-cells.

Which regions are driving the growth of the zanubrutinib market?

The growth of the zanubrutinib market is driven by regions such as North America, Europe, and the Asia-Pacific, due to factors like advanced healthcare infrastructure, high incidence rates of B-cell malignancies, and increasing healthcare investments.

How has zanubrutinib performed financially in recent quarters?

In the third quarter of 2024, product revenue from BRUKINSA (zanubrutinib) increased by 67% compared to the same period in 2023, reaching $993 million. This growth was primarily driven by increased sales in the U.S. and Europe.

What are the key investment opportunities in the zanubrutinib market?

The key investment opportunities include advancements in clinical research, strategic partnerships, and investments in the biotechnology sector, particularly in companies developing and marketing targeted therapies.

How does zanubrutinib compare to other BTK inhibitors in terms of clinical outcomes?

Zanubrutinib has shown superior long-term outcomes compared to other BTK inhibitors like ibrutinib, with higher progression-free survival (PFS) rates at the 36-month mark.

What role do strategic partnerships play in the development and commercialization of zanubrutinib?

Strategic partnerships between pharmaceutical companies and research institutions are instrumental in enhancing drug formulations, exploring new indications, and expanding market access for zanubrutinib.

Sources

1. Market Research Intellect: "Zanubrutinib Market Size And Projection"
2. BeiGene: "BeiGene Announces Third Quarter 2024 Financial Results and Corporate Updates"
3. BeiGene: "BeiGene Reports First Quarter 2024 Financial Results and Business Updates"
4. ISPOR: "Budget Impact Analysis of Zanubrutinib for Treatment of Relapsed or Refractory Chronic Lymphocytic Leukemia"
5. HMP Global Learning Network: "Zanubrutinib Shows Superior Long-Term Outcomes vs Ibrutinib in Relapsed/Refractory CLL"