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 Beone Medicines Usa and is included in two NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zanubrutinib has ninety-nine patent family members in thirty-two countries.

One supplier is listed for this compound.

Summary for ZANUBRUTINIB

International Patents:	99
US Patents:	13
Tradenames:	1
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	163
What excipients (inactive ingredients) are in ZANUBRUTINIB?	ZANUBRUTINIB excipients list
DailyMed Link:	ZANUBRUTINIB at DailyMed

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

Dosage:

CAPSULE;ORAL

Dosage:

TABLET;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
City of Hope Medical Center	PHASE1
National Cancer Institute (NCI)	PHASE1
BeiGene	PHASE4

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
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes			Y	Y
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No			Y	Y
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes			Y	Y
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No

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/004978Brukinsa 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	3500299	UTILISATION D'UNE COMBINAISON COMPRENANT UN INHIBITEUR DE BTK POUR LE TRAITEMENT DE CANCERS (USE OF A COMBINATION COMPRISING A BTK INHIBITOR FOR TREATING CANCERS)
Denmark	2989106
Slovenia	2989106
South Korea	102793825
Taiwan	201811794	Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetrahydropyrazolo[1,5-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	CR 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	LUC00250	Luxembourg		PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
2989106	CA 2022 00008	Denmark		PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123
2989106	C202230011	Spain		PRODUCT NAME: ZANUBRUTINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1576; DATE OF AUTHORISATION: 20211122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1576; DATE OF FIRST AUTHORISATION IN EEA: 20211122

Market Dynamics and Financial Trajectory for Zanubrutinib

Last updated: July 28, 2025

Introduction

Zanubrutinib (Brukinsa), developed by BeiGene, Ltd., is a selective Bruton's tyrosine kinase (BTK) inhibitor approved for the treatment of various B-cell malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström's macroglobulinemia (WM). Since its approval, it has positioned itself within a competitive oncology market, driven by innovative therapeutic mechanisms, expanding indications, and evolving market dynamics. This analysis explores the key factors shaping zanubrutinib's market trajectory and the projected financial outlook based on recent industry insights.

Market Landscape and Competitive Positioning

Zanubrutinib entered a rapidly expanding bracket of BTK inhibitors, with rivals like ibrutinib (Imbruvica) from Pharmacyclics and acalabrutinib (Calquence) from AstraZeneca. Unlike first-generation BTK inhibitors, zanubrutinib offers higher selectivity, theoretically reducing off-target adverse effects — a pivotal differentiator. Its clinical trials demonstrate comparable or superior efficacy and safety profiles, fostering confidence among clinicians and influencing prescribing patterns.

The ongoing expansion of indications enhances its market potential. The FDA’s approval for MCL (2019), WM (2020), and CLL (2021) signifies a diversified portfolio within hematologic malignancies. In China, BeiGene’s home market, zanubrutinib benefits from a broad patient base and supportive regulatory policies, facilitating domestic market penetration. Internationally, approvals in Europe and other regions are underway, with regulatory reviews potentially broadening access.

Market Drivers and Challenges

Drivers

• Efficacy and Safety Profile: Clinical trials highlight zanubrutinib’s high response rates and lower adverse events like atrial fibrillation and bleeding, compared to competing agents.
• Expanded Indications: The potential to treat a diverse array of B-cell malignancies makes it a versatile candidate for on-label and off-label use.
• Regulatory Approvals: Accelerated and full approvals in multiple jurisdictions support swift market entry.
• Strategic Partnerships: BeiGene's collaborations, including with Novartis and others, amplify distribution and research avenues.

Challenges

• Intense Competition: Established BTK inhibitors like ibrutinib dominate with entrenched market share and robust clinical data.
• Pricing and Reimbursement: Cost considerations and reimbursement policies in different countries influence prescription volume.
• Patent and Market Exclusivity: Patent lifespans and potential biosimilar entries could impact long-term revenue.

Market Dynamics: Trends and Opportunities

The global hematological malignancies market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-8% through 2030 (source: Fortune Business Insights). North America, Europe, and Asia-Pacific are principal markets, with North America holding roughly 40% of the market share, driven by high disease prevalence and advanced healthcare infrastructure.

In the coming years, zanubrutinib’s trajectory will benefit from:

• Pipeline Expansion: Ongoing clinical trials examining head-to-head comparisons and combinations with other agents, including venetoclax, have the potential to expand indications and improve outcomes.
• Personalized Medicine: Biomarker-driven patient selection may enhance efficacy and minimize adverse effects, supporting premium pricing strategies.
• Market Penetration Strategies: BeiGene’s focus on emerging markets and strategic partnerships can accelerate adoption globally.

Financial Trajectory: Projections and Outlook

Historical Performance

Since its US approval in 2019, zanubrutinib’s sales globally have shown rapid growth, reaching approximately $400 million in 2022, according to company disclosures[1]. Growth was driven predominantly by US sales, complemented by increasing European and Asian penetration.

Forecasted Revenue

Industry analysts project zanubrutinib could surpass $1 billion in peak annual sales by the mid-2020s, contingent upon:

• Market Expansion: Broader approval in additional indications such as Richter's transformation and other lymphomas.
• Market Share Gains: Outpacing rivals through superior safety profile and demonstrated efficacy.
• Pricing Dynamics: Adoption of value-based pricing models and reimbursement negotiations.

Profitability and Investment Outlook

BeiGene is investing heavily in clinical development and commercialization efforts. Revenue forecasts indicate a transition from initial investments to profitability in select markets within 3-5 years, aligning with broader industry trends in oncology drugs. The company's focus on Asia-Pacific and emerging markets may offset slower uptake in mature markets, providing a diversified revenue stream.

Regulatory and Market Expansion Outlook

Regulatory agencies have shown openness to innovative therapies. Pending approvals and forthcoming clinical data will be pivotal. BeiGene’s strategy to seek supplemental indications, coupled with its robust global footprint, positions zanubrutinib favorably for sustained financial growth.

Risks and Considerations

Uncertainties include potential regulatory setbacks, market saturation, competitive pricing pressures, and evolving therapeutic landscapes. Additionally, the advent of novel targeted therapies or immunotherapies could challenge the current market share of BTK inhibitors.

Key Takeaways

• Zanubrutinib's high selectivity and favorable safety profile position it distinctly within the highly competitive BTK inhibitor market.
• Expansion into additional indications and ongoing clinical trials will be critical drivers of future sales growth.
• Market penetration will depend on regulatory approvals, reimbursement negotiations, and competitive dynamics.
• The global hematology-oncology market offers significant growth opportunities, with zanubrutinib poised to capture increasing market share.
• Strategic collaborations and regional expansion will be pivotal in achieving optimal financial performance.

Conclusion

Zanubrutinib’s market dynamics indicate a promising trajectory driven by clinical differentiation, expanding indications, and strategic market access. While competition remains intense, its favorable safety profile and ongoing pipeline development reinforce its potential to capture a significant share of the growing B-cell malignancies market. Investors and healthcare stakeholders should monitor upcoming clinical data, regulatory decisions, and market trends to optimize decision-making in this evolving landscape.

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FAQs

1. What are the main factors differentiating zanubrutinib from other BTK inhibitors?
   Zanubrutinib's high selectivity for BTK reduces off-target effects, leading to fewer adverse events such as atrial fibrillation and bleeding, enhancing patient adherence and safety.

2. Which indications does zanubrutinib currently hold regulatory approval for?
   Approved in the US and several other jurisdictions for mantle cell lymphoma, Waldenström’s macroglobulinemia, and chronic lymphocytic leukemia, among others.

3. What is the outlook for zanubrutinib’s global market expansion?
   Regulatory approvals are expanding in Europe, Asia-Pacific, and other regions, supported by clinical trial data demonstrating efficacy across multiple B-cell malignancies, bolstering future sales potential.

4. How does zanubrutinib's competitive profile impact its financial projections?
   Superior safety and efficacy profiles can drive higher market share, premium pricing, and broader adoption, thus positively influencing revenue growth projections.

5. What are the main risks facing zanubrutinib’s commercial success?
   Competitive pressures from existing BTK inhibitors, potential regulatory hurdles, pricing challenges, and the emergence of novel therapies remain key risks.

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References

[1] BeiGene’s Annual and Quarterly Financial Reports, 2022.