BRUKINSA Drug Patent Profile

When do Brukinsa patents expire, and when can generic versions of Brukinsa launch?

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

NDA:

213217

Dosage:

CAPSULE;ORAL

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.

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
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes			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			Y
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes
Beone Medicines Usa	BRUKINSA	zanubrutinib	TABLET;ORAL	218785-001	Jun 10, 2025		RX	Yes	Yes			Y	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
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
Taiwan	202112376	Oral solid tablet comprising bruton's tyrosine kinase inhibitor and preparation method therefor
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
World Intellectual Property Organization (WIPO)	2018033135

Supplementary Protection Certificates for BRUKINSA

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
2989106	C02989106/01	Switzerland		FORMER OWNER: BEIGENE SWITZERLAND GMBH, CH
2989106	122022000013	Germany		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122

Market Dynamics and Financial Trajectory for BRUKINSA

Last updated: July 27, 2025

Introduction

BRUKINSA (zanubrutinib) embodies a significant advancement in the oncology therapeutics landscape as a potent, selective Bruton’s tyrosine kinase (BTK) inhibitor. Developed by BeiGene, this drug has rapidly garnered attention for its efficacy in treating B-cell malignancies, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenström's macroglobulinemia (WM). Its market trajectory is influenced by dynamic factors ranging from clinical performance, regulatory pathways, competitive landscape, and evolving treatment paradigms, to commercial strategies and geopolitical considerations.

Market Landscape and Therapeutic Positioning

BRUKINSA entered a competitive arena populated by established BTK inhibitors such as ibrutinib (Imbruvica) and acalabrutinib (Calquence). While these agents have achieved significant market penetration, BRUKINSA's unique profile—marked by higher selectivity and a potentially improved safety profile—positions it as a preferred option, especially for patients intolerant to existing therapies. Its approval across multiple jurisdictions, including the US, EU, China, and other regions, catalyzes its potential to capture significant market share.

The drug's initial approvals focused on relapsed/refractory MCL and CLL/SLL, where unmet needs persist due to resistance and toxicity concerns. As clinical trial data continues to demonstrate favorable efficacy and tolerability, especially with less bleeding and atrial fibrillation risks, physicians may increasingly favor BRUKINSA, further expanding its utilization.

Market Drivers

1. Clinical Efficacy and Safety Profile:
   BeiGene’s pivotal trials (e.g., BOSMA trial for MCL) reveal robust response rates with manageable safety profiles, giving BRUKINSA an edge over competitors. The ongoing head-to-head studies (e.g., ASPEN trial comparing BRUKINSA and ibrutinib) are likely to influence prescribing patterns favorably if results confirm superior safety or efficacy.

2. Regulatory Approvals and Expanding Indications:
   Regulatory momentum—such as recent approvals in Europe and China—broadens the geographic footprint. BeiGene's strategic expansion into additional indications, such as first-line therapy or other B-cell malignancies, diversifies revenue streams and increases market resilience.

3. Pricing and Reimbursement Dynamics:
   BeiGene’s pricing strategies, especially in China where cost-effectiveness significantly influences reimbursement, can accelerate market penetration. Demonstrated cost-effectiveness compared to existing therapies will facilitate favorable reimbursement decisions across regions.

4. Innovation and Clinical Pipeline:
   The ongoing development of combination therapies incorporating BRUKINSA (e.g., with venetoclax or obinutuzumab) aimed at achieving deeper remissions and fixed-duration therapies enhances market appeal. Positive clinical outcomes could position BRUKINSA as a backbone in combination regimens.

5. Manufacturing and Supply Chain:
   BeiGene's manufacturing capabilities, especially with local production in China, support sustained supply and price competitiveness, empowering market expansion in Asia and beyond.

Market Challenges and Risks

• Competitive Saturation:
  The existing dominance of ibrutinib and acalabrutinib poses a significant barrier. Efficacy, safety, and pricing differentials will determine BRUKINSA’s share.

• Patent and Regulatory Risks:
  Patent litigations or biosimilar entries could impact profitability, especially if biosimilars gain approval rapidly in key markets.

• Clinical Adoption Barriers:
  Physicians’ familiarity with established therapies, alongside the need for convincing head-to-head trial data, may temper acceleration.

• Global Geopolitical Factors:
  International tensions and trade policies could influence supply chains, IP rights, and market access, notably in China, the U.S., and Europe.

Financial Trajectory Analysis

Revenue Growth Projections

BeiGene’s financial forecasts estimate rapid revenue growth driven by a combination of existing approvals and expanding indications. In 2022, sales of BRUKINSA approximated several hundred million dollars globally, with significant contributions from both the US and China markets (according to BeiGene’s financial statements and analyst estimates) [1].

By 2025, industry analysts project BRUKINSA could surpass $1 billion in annual sales, contingent upon approval for additional indications, sustained clinical success, and effective commercialization (e.g., in Europe and emerging markets). The growth is expected to be approximately 20-30% year-over-year during this period.

Profitability and Investment

BeiGene’s strategic focus includes investing heavily in R&D, manufacturing, and market expansion to capitalize on BRUKINSA’s commercial potential. Gross margins are projected to improve with scale and manufacturing efficiencies, contributing positively to profitability. However, high ongoing R&D expenditure on pipeline products and clinical trials may temper net margins in the near term.

Market Penetration Dynamics

Adoption rates will be bolstered by clinical data, regulatory approvals, and competitive pricing strategies. In the US, payer coverage and formulary inclusion will closely influence revenue trajectory. Emerging markets, especially China, will offer significant growth potential due to lower treatment costs and local manufacturing, with BeiGene leveraging its strong domestic presence.

Long-term Outlook

Over the next five years, BRUKINSA's financial performance hinges on successful expansion into first-line treatments and combination regimens. With anticipated pipeline progress, including potential approvals for other B-cell malignancies, revenue streams could diversify further. The drug’s outlook is reinforced by the global shift towards targeted therapies aimed at increasing remission durations and reducing toxicity.

Key Market Segments and Growth Opportunities

• Mantle Cell Lymphoma (MCL): Initial approval in this indication positions BRUKINSA as a preferred therapy in relapsed/refractory settings.
• Chronic Lymphocytic Leukemia (CLL): With increasing sales, especially post-approval for first-line treatment, this segment remains a core revenue driver.
• Waldenström’s Macroglobulinemia (WM): Growing patient populations and clinical trial data support expansion.
• Combination Therapies: Future revenue stems from approved and pipeline combination regimens, especially fixed-duration treatments.

Competitive Landscape and Strategic Positioning

BRUKINSA’s success will heavily depend on differentiating its efficacy, safety, and pricing. Its clinical advantages over ibrutinib and acalabrutinib, particularly in safety profiles, appeal to physicians and payers. BeiGene's regional manufacturing in China affords pricing leverage in Asian markets, crucial for sustained revenue growth.

Simultaneously, aggressive pursuit of new indications, combination therapy approvals, and strategic partnerships are essential to maintaining an innovative edge, ensure competitive advantages, and drive long-term revenues.

Conclusion

BRUKINSA is positioned for robust growth within a dynamic and competitive market landscape. Its market trajectory will be shaped by clinical validation, regulatory expansion, strategic pricing, and execution of pipeline development. As the global focus on precision oncology intensifies, BRUKINSA’s distinctive profile and strategic initiatives are poised to generate significant financial returns, reinforcing BeiGene’s position as a leading innovator in targeted cancer therapies.

---

Key Takeaways

• Market Penetration: BRUKINSA’s high selectivity and safety profile confer a competitive edge, supporting rapid uptake over traditional BTK inhibitors.
• Revenue Growth: Industry forecasts suggest surpassing $1 billion in annual sales by 2025, driven by existing indications and pipeline expansion.
• Geographic Expansion: Regulatory approvals in China, the US, and Europe expand access, especially considering local manufacturing advantages in China.
• Pipeline and Combinations: Future growth depends on successful clinical trials for newer indications and combination therapies, potentially extending treatment durations and improving efficacy.
• Competitive Strategy: Differentiation through safety, efficacy, and pricing will remain key to solidifying market share amid intense competition.

---

FAQs

1. What distinguishes BRUKINSA from other BTK inhibitors?
   BRUKINSA’s high selectivity for BTK results in fewer off-target effects, which translates to a better safety profile, notably less bleeding and atrial fibrillation, compared to earlier BTK inhibitors such as ibrutinib.

2. Which markets are the most promising for BRUKINSA’s growth?
   The United States and China currently represent the largest markets. Europe offers expanding opportunities, provided regulatory approvals and reimbursement landscapes are favorable.

3. What are the main factors influencing BRUKINSA’s market penetration?
   Demonstrated clinical efficacy, safety profile, regulatory approvals, physician acceptance, reimbursement strategies, and competitive pricing are critical drivers.

4. How does BeiGene plan to sustain BRUKINSA’s growth amid competition?
   Through expanding indication approvals, innovative combination therapies, pipeline advancements, strategic collaborations, and cost-effective manufacturing.

5. What are potential risks that could impact BRUKINSA’s financial trajectory?
   Key risks include aggressive competition, patent challenges, delays in clinical development, unfavorable regulatory changes, and geopolitical tensions affecting supply and market access.

---

References

[1] BeiGene financial statements, 2022 annual report.