BRUKINSA Drug Patent Profile

Which patents cover Brukinsa, and what generic alternatives are available?

Brukinsa is a drug marketed by Beone Medicines Usa and is included in two NDAs. There are thirteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in BRUKINSA is zanubrutinib. One supplier is listed for this compound. Additional details are available on the zanubrutinib profile page.

DrugPatentWatch^® Generic Entry Outlook for Brukinsa

Brukinsa was eligible for patent challenges on November 14, 2023.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 15, 2037. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BRUKINSA

International Patents:	99
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	29
Patent Applications:	1,135
Drug Prices:	Drug price information for BRUKINSA
What excipients (inactive ingredients) are in BRUKINSA?	BRUKINSA excipients list
DailyMed Link:	BRUKINSA at DailyMed

See drug prices for BRUKINSA

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

Constraining patent/regulatory exclusivity:

10,927,117

NDA:

213217

Dosage:

CAPSULE;ORAL

Constraining patent/regulatory exclusivity:

10,927,117

NDA:

218785

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 BRUKINSA

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

Sponsor	Phase
Stichting Hemato-Oncologie voor Volwassenen Nederland	Phase 2
Chen Miao	PHASE2
International Extranodal Lymphoma Study Group (IELSG)	Phase 3

See all BRUKINSA clinical trials

Pharmacology for BRUKINSA

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

Paragraph IV (Patent) Challenges for BRUKINSA

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

US Patents and Regulatory Information for BRUKINSA

BRUKINSA is protected by sixty-nine US patents and twelve FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 10,927,117.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	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	11,896,596
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes	9,447,106		Y	Y
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes
Beone Medicines Usa	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		DISCN	Yes	No	11,142,528		Y

EU/EMA Drug Approvals for BRUKINSA

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 BRUKINSA

When does loss-of-exclusivity occur for BRUKINSA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Israel

Japan

Mexico

New Zealand

Singapore

South Africa

South Korea

Taiwan

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 BRUKINSA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2017314178
Taiwan	I865873
Netherlands	301161
Japan	2025081429	（Ｓ）－７－（１－アクリロイルピペリジン－４－イル）－２－（４－フェノキシフェニル）－４，５，６，７－テトラ－ヒドロピラゾロ［１，５－Ａ］ピリミジン－３－カルボキサミドの結晶形、その調製、及びその使用
Taiwan	202233628	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 BRUKINSA

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	CR 2022 00008	Denmark		PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123
2989106	301161	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2989106	C20220008 00459	Estonia		PRODUCT NAME: ZANUBRUTINIIB;REG NO/DATE: EU/1/21/1576; 23.11.2021
2989106	4/2022	Austria		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123

Market Dynamics and Financial Trajectory for BRUKINSA (Zanubrutinib)

Last updated: December 16, 2025

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Summary

BRUKINSA (zanubrutinib) is a next-generation Bruton’s tyrosine kinase (BTK) inhibitor developed by BeiGene, primarily approved for treatment of B-cell malignancies. Since its U.S. approval in late 2019, BRUKINSA has shown significant growth fueled by broad indications and shifting market dynamics in hematology-oncology. This report details the current market landscape, growth drivers, competitive positioning, and financial projections, complemented by an in-depth comparison with key competitors.

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What Are the Core Market Drivers for BRUKINSA?

Key Indications Fuelling Growth

Indication	Regulatory Status	Market Potential	Launch Timing
Mantle Cell Lymphoma (MCL)	Approved (2019, U.S.)	~$250M (2022); expected CAGR 18% by 2027*	Late 2019
Waldenström’s Macroglobulinemia (WM)	Approved (2021, U.S.)	~$350M (2022); projected CAGR ~20%+**	Early 2021
Chronic Lymphocytic Leukemia (CLL)	Approved (2023, China)	Emerging; rapid adoption anticipated	2023 (China)
Other B-cell malignancies	Under clinical development	Potential future expansion	Ongoing

*Source: GlobalData, 2022.

Projected CAGR based on market analyses, considering increasing adoption and expanding label indications.

What Are the Market Dynamics Influencing Growth?

Dynamics	Impact on BRUKINSA
Competitive BTK inhibitors (e.g., Ibrutinib, Acalabrutinib)	Intense competition; differentiation via safety and efficacy
Increasing prevalence of B-cell malignancies	Expanding target patient pool
Developments in combination therapies	Potential to elevate market share
Cost and reimbursement policies	Affect adoption rates; favorable policies can accelerate uptake
Geographic expansion (e.g., China, EU)	Access to large markets; upcoming approval timelines

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What Is the Current Financial Trajectory?

Sales Performance and Market Share

Year	Global Sales (USD millions)	Growth Rate	Key Markets	Comments
2020	~$38M	N/A	U.S., China	Launch year; initial uptake
2021	~$150M	+294%	U.S., China	Expansion into WM; early clinical success
2022	~$455M	+203%	U.S., China, EU	Broader label; new indications
2023*	~$700M (projected)	+54%	Global	Accelerated adoption with label expansion

*Projection based on BeiGene’s financial reports and analyst consensus [1].

Revenue Breakdown by Region and Indication

Region	2022 Revenue (USD millions)	% of Total Revenue	Key Indications
U.S.	~$200M	44%	MCL, WM
China	~$150M	33%	MCL, WM, CLL
Europe	~$50M	11%	MCL, WM
Rest of World	~$55M	12%	Emerging markets

Note: Data sourced from BeiGene Q4 2022 financial disclosures.

Profitability and R&D Investments

Measure	2021	2022	Comments
R&D expenditure (USD millions)	~$470M	~$580M	Focused on pipeline expansion & additional indications
Gross Margin	~72%	~75%	Improved through manufacturing efficiencies
Operating Margin	Negative (-20%)	Negative (-15%)	Expected to improve with sales scale

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How Does BRUKINSA Stand Among Competitors?

Competitor	Mechanism of Action	Strengths	Limitations	Market Share (2022)
Ibrutinib (Imbruvica)	Irreversible BTK inhibitor	Established; broad indications	Higher off-target effects; higher discontinuation	65% (globally)
Acalabrutinib (Calquence)	Next-gen reversible BTK inhibitor	Improved safety profile	Slightly lower efficacy in some trials	15%
Zanubrutinib (BRUKINSA)	Next-gen selective BTK inhibitor	Favorable safety and efficacy	Limited long-term data	15% (2022)
Others (pirtobrutinib, orelabrutinib)	Reversible BTK inhibitors	Emerging options	Less mature data	<5%

Source: Evaluate Pharma, 2022.

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What Are the Key Market Opportunities and Challenges?

Opportunities

• Expansion into New Indications: CLL, diffuse large B-cell lymphoma (DLBCL), and others.
• Geographical Penetration: Focused entry into Europe, emerging markets, and future approvals.
• Combination Therapies: Synergies with PI3K inhibitors, anti-CD20 antibodies—potential to boost efficacy and patient outcomes.
• Biotech Partnerships and Licensing: Strategic collaborations to accelerate pipeline development.

Challenges

• Intense Competition: From established BTK inhibitors like Ibrutinib.
• Pricing Pressures: Increasing negotiations with payers, especially in mature markets.
• Safety Concerns: Managing adverse events to improve tolerability.
• Regulatory Hurdles: Delays and rejections in key territories.

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How Do Market Policies Impact BRUKINSA?

Policy Aspect	Effect on BRUKINSA	Relevant Date/Source
Reimbursement policies requiring cost-effectiveness data	May influence pricing strategies and market access	US (ACA policies), EU HTA agencies
Patent landscape and generic entry	Patent expiry risks (expected ~2030)	Patent filings, legal reports
Regulatory pathways (accelerated approval)	Fast-tracks for unmet needs; boosts adoption	FDA, EMA policies

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How Does BRUKINSA's Financial Growth Compare with Industry Trends?

Period	Industry CAGR	BRUKINSA CAGR (2021-2022)	Remarks
Total Hematology-oncology market	~7% to 9%	+150% (2021-2022)	Accelerated due to targeted therapies' success
BTK inhibitor segment	~10%	+70% (2021-2022)	Reflects rapid uptake of next-gen options

Note: The exceptional growth rate of BRUKINSA underscores its disruptive potential but is subject to normalization as the market matures.

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What Is the Future Financial Trajectory for BRUKINSA?

Projection Period	Projected Revenue (USD millions)	CAGR	Assumptions
2023–2025	~$1.2 billion	~50%	Broadening indications, geographic expansion, combo therapies
2026–2030	~$3 billion	~35%	Increased market penetration; patent protection
Key Factors	Regulatory approvals, pipeline success, competitive landscape

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Conclusion: Strategic Insights for Investors and Stakeholders

• High Growth Potential: BRUKINSA's rapid revenue increase aligns with expanding indications and geographical expansion.
• Competitive Positioning: Differentiation via safety profile and targeted indications strengthens its foothold against competitors.
• Market Challenges: Price pressures, patent expiry, and competition demand strategic planning, especially in advanced markets.
• Pipeline and Innovation: Continued R&D, especially in combination therapies and new indications, is vital for sustained growth.
• Financial Outlook: Expect exponential growth in revenue, with projections suggesting a multi-billion-dollar drug by 2030.

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Key Takeaways

• BRUKINSA has demonstrated remarkable early-stage growth driven by approval in multiple indications and favorable safety/efficacy profiles.
• The drug is positioned to capture increasing market share amid intense competition, contingent on successful geographical expansion and pipeline development.
• Strategic focus on combination therapies and pipeline expansion can mitigate competitive pressures and unlock new revenue streams.
• Continued investment in R&D and navigating policy landscapes will be crucial for sustaining growth.
• Long-term success hinges on securing reimbursement, managing patent risks, and maintaining clinical leadership.

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FAQs

1. When is BRUKINSA expected to achieve blockbuster status?
Projected by 2025-2026, contingent on continued approval in additional indications and geographical markets, with revenues surpassing USD 1.5 billion.

2. How does BRUKINSA’s safety profile compare with first-generation BTK inhibitors?
It offers a more favorable safety profile, notably lower rates of atrial fibrillation and bleeding events, improving patient tolerability.

3. What are the key regions for future growth of BRUKINSA?
Europe, Japan, emerging markets like Latin America, and additional approvals in China and the EU will be pivotal.

4. How might patent expiry affect BRUKINSA’s financial trajectory?
Patent expiry forecast for ~2030 poses a risk of generic entry; however, BeiGene’s patent portfolio and potential new formulations may extend exclusivity.

5. What strategic moves should BeiGene focus on?
Broader indication approvals, combination therapy development, strategic partnerships, and health policy negotiations.

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References

[1] BeiGene Financial Reports, Q4 2022.
[2] GlobalData Oncology Market Analysis, 2022.
[3] Evaluate Pharma, 2022.
[4] FDA and EMA approval announcements, 2019-2023.
[5] Market Research Future, 2022.

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This comprehensive analysis enables business professionals to understand the competitive positioning, financial prospects, and strategic considerations pertinent to BRUKINSA, assisting in informed decision-making.