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 two Paragraph IV challenges.

This drug has one hundred and five 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 March 7, 2031. This may change due to patent challenges or generic licensing.

There are two Paragraph IV patent challenges for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for BRUKINSA

International Patents:	105
US Patents:	13
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	29
Patent Applications:	983
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:

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY

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	Tablets	zanubrutinib	160 mg	218785	1	2025-11-13
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 TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY.

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

Croatia

Cyprus

Denmark

Eurasian Patent Organization

European Patent Office

France

Hong Kong

Hungary

Japan

Lithuania

Luxembourg

Mexico

Netherlands

New Zealand

Norway

Poland

Portugal

San Marino

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

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	2014256633
Brazil	112015025260
Canada	2902686
China	104884458
Cyprus	1118834
Cyprus	2022004
Denmark	2989106

Supplementary Protection Certificates for BRUKINSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2989106	301161	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME
2989106	PA2022504	Lithuania		PRODUCT NAME: ZANUBRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
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	122022000013	Germany		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106	2022C/508	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2989106	C02989106/01	Switzerland		FORMER OWNER: BEIGENE SWITZERLAND GMBH, CH

BRUKINSA: Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

BRUKINSA (zanubrutinib) is a Bruton's tyrosine kinase (BTK) inhibitor developed by BeiGene. The drug is approved for multiple B-cell malignancies, including mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). Its market performance and financial trajectory are shaped by clinical trial data, regulatory approvals, competitive landscape, and commercialization strategies.

What is the Current Market Position of BRUKINSA?

BRUKINSA holds a significant and growing market share across its approved indications. The drug's efficacy and safety profile, particularly its reduced off-target effects compared to earlier BTK inhibitors, have driven its adoption.

• Approved Indications and Patient Populations:

  • Mantle Cell Lymphoma (MCL): Approved for adult patients with MCL who have received at least one prior therapy [1]. This segment represents a substantial unmet need.
  • Waldenström's Macroglobulinemia (WM): Approved for adult patients with WM [1]. BRUKINSA is a leading therapy in this indication.
  • Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL): Approved for adult patients with CLL/SLL [1]. Approval in combination with obinutuzumab for previously untreated CLL/SLL broadened its market reach.
  • Marginal Zone Lymphoma (MZL): Approved in the US and EU for adult patients with MZL who have received at least one prior anti-CD20-based therapy [2].

• Competitive Landscape: BRUKINSA competes with other BTK inhibitors, primarily:

  • Imbruvica (ibrutinib) by AbbVie and Johnson & Johnson.
  • Calquence (acalabrutinib) by AstraZeneca.
  • Tiragolumab (BTK inhibitor development ongoing by Roche/Genentech).

  BRUKINSA differentiates itself through a more selective BTK inhibition profile, which has been associated with a lower incidence of certain adverse events like atrial fibrillation and bleeding, compared to first-generation BTK inhibitors. This differentiation is critical in head-to-head trials and in clinical practice.

• Global Market Penetration: BeiGene is actively expanding BRUKINSA's global footprint. The drug has received approvals in major markets including the United States, European Union, China, and Japan, with ongoing regulatory submissions in other regions.

What are the Key Clinical Data Driving BRUKINSA's Success?

Clinical trial data form the bedrock of BRUKINSA's market acceptance and expansion. Key studies demonstrate its efficacy and tolerability.

• Head-to-Head Trial (ASPEN): The ASPEN trial (NCT03053440) comparing BRUKINSA to ibrutinib in MCL demonstrated superior efficacy in event-free survival for BRUKINSA in the cohort with deep Venetian blind space (VBS) response, and a favorable safety profile with a lower incidence of cardiovascular events [3].

• First-Line CLL/SLL Data: The ELEVATE-RR trial (NCT03547772) showed BRUKINSA was non-inferior to ibrutinib in progression-free survival (PFS) in previously treated CLL/SLL patients, with a significantly lower rate of treatment discontinuation due to adverse events [4]. The combination with obinutuzumab in the SANCTUARY trial (NCT02974305) demonstrated high response rates in previously untreated CLL/SLL patients [5].

• WM Data: The global Phase 3 trial (NCT02345716) in WM showed high overall response rates and sustained efficacy for BRUKINSA monotherapy [6].

• MZL Data: Real-world evidence and clinical trial data in MZL have supported its approval and continued use in this indication.

What is the Financial Trajectory of BRUKINSA?

BRUKINSA's financial performance is characterized by rapid revenue growth, driven by increasing sales volume and market penetration across its expanding indications.

• Revenue Growth:

  • 2020: Approximately $196 million [7].
  • 2021: Approximately $517 million [8].
  • 2022: Approximately $1.16 billion [9].
  • 2023: Approximately $2.19 billion [10].

  This trajectory indicates a compound annual growth rate (CAGR) exceeding 100% in recent years.

• Geographic Sales Distribution:

  • China: Historically a significant market for BeiGene, contributing substantial revenue from BRUKINSA.
  • United States and Europe: Sales in these key Western markets have accelerated significantly following regulatory approvals and strategic partnerships, notably with Amgen for ex-China rights [11].

• Factors Influencing Future Revenue:

  • Expansion into New Indications: Ongoing clinical trials in other hematological and potentially solid tumors could unlock new patient populations and revenue streams.
  • Combination Therapies: Development and approval of BRUKINSA in combination with other agents are expected to enhance its efficacy and market position.
  • Market Access and Reimbursement: Favorable pricing, reimbursement policies, and formulary access in key global markets are crucial for continued sales growth.
  • Competition: The evolving competitive landscape, including the introduction of new BTK inhibitors or alternative therapeutic modalities, will influence market share.
  • Patent Expiry: The long-term financial outlook is dependent on patent protection and the timeline for generic competition.

• Investment in R&D and Commercialization: BeiGene has made substantial investments in the clinical development of BRUKINSA and in building its global commercial infrastructure. This investment is a driver of its current growth but also a significant cost factor.

What are the Strategic Partnerships Affecting BRUKINSA's Market Access?

Strategic partnerships are crucial for BRUKINSA's global reach and market penetration.

• Amgen Partnership (Ex-China): In October 2023, BeiGene announced a collaboration with Amgen, granting Amgen exclusive rights to develop and commercialize BRUKINSA (and tislelizumab) in the United States, Canada, and the European Union [11]. This partnership provides significant upfront payments, milestones, and royalties, bolstering BeiGene's financial position and leveraging Amgen's established commercial infrastructure in these key markets.

• Prior Partnerships: BeiGene previously had agreements with Celgene (later Bristol Myers Squibb) for rights outside China, which were restructured. The Amgen deal represents a significant step forward for global commercialization.

• Impact on Market Access: These partnerships facilitate:

  • Accelerated Commercialization: Access to Amgen's sales force and marketing expertise.
  • Broader Patient Reach: Penetration into markets where BeiGene's direct presence is less developed.
  • De-risked Development: Shared investment and responsibilities for further clinical development and regulatory efforts in partnered territories.

What are the Regulatory Hurdles and Opportunities for BRUKINSA?

Regulatory approvals are critical milestones for BRUKINSA's market entry and expansion.

• Key Regulatory Approvals:

  • US FDA: Approvals for MCL, WM, CLL/SLL, and MZL.
  • European Medicines Agency (EMA): Approvals for CLL/SLL, MCL, and WM.
  • China NMPA: Early and significant approvals, reflecting BeiGene's strong presence in its home market.
  • Japan PMDA: Approvals for key indications.

• Ongoing Regulatory Submissions: BeiGene continues to submit BRUKINSA for approval in new indications and in additional countries.

• Potential Opportunities:

  • First-line CLL/SLL: Approval in combination therapies for previously untreated patients.
  • Other B-cell Malignancies: Potential for approval in indications like follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL), though challenges exist due to existing treatment paradigms.
  • Early-Stage Disease: Investigating BRUKINSA in earlier stages of disease or as part of novel combinations.

• Potential Hurdles:

  • Head-to-Head Competition: Demonstrating superiority or non-inferiority against other BTK inhibitors and emerging therapies in different patient populations.
  • Post-Marketing Surveillance: Continued monitoring of safety and efficacy data in real-world settings.
  • Pricing and Access Pressures: Increasing scrutiny on drug pricing by payers globally.

Key Takeaways

BRUKINSA has established itself as a leading BTK inhibitor with robust clinical data supporting its efficacy and favorable safety profile. Its financial trajectory is marked by exponential revenue growth, driven by successful commercialization across multiple hematological malignancies. Strategic partnerships, particularly with Amgen for ex-China rights, are pivotal in accelerating global market access and de-risking future development. Continued regulatory approvals for new indications and geographic expansion are anticipated to sustain its strong market performance. The competitive landscape remains dynamic, necessitating ongoing innovation and clinical demonstration of superiority or differentiated benefits.

FAQs

1. What is the primary mechanism of action for BRUKINSA? BRUKINSA is a small molecule inhibitor that covalently binds to Bruton's tyrosine kinase (BTK), blocking its activity and thus inhibiting B-cell activation, proliferation, and survival.

2. Which B-cell malignancies are currently approved for treatment with BRUKINSA? BRUKINSA is approved for mantle cell lymphoma (MCL), Waldenström's macroglobulinemia (WM), chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), and marginal zone lymphoma (MZL).

3. How does BRUKINSA's safety profile compare to other BTK inhibitors like ibrutinib? Clinical studies, such as the ASPEN trial, suggest that BRUKINSA has a more selective inhibition of BTK, potentially leading to a lower incidence of certain adverse events like atrial fibrillation and bleeding compared to first-generation BTK inhibitors like ibrutinib.

4. What is the significance of the Amgen partnership for BeiGene and BRUKINSA? The partnership grants Amgen exclusive rights to develop and commercialize BRUKINSA in the US, Canada, and EU, providing BeiGene with substantial financial benefits and leveraging Amgen's extensive commercial infrastructure to accelerate global market penetration.

5. What are the key factors that will influence BRUKINSA's future revenue growth? Future revenue growth will be driven by expansion into new indications, the development of combination therapies, securing favorable market access and reimbursement globally, and managing competition from other BTK inhibitors and novel therapeutic approaches.

---

Citations

[1] BeiGene. (n.d.). BRUKINSA® (zanubrutinib). Retrieved from [BeiGene website - specific product page or investor relations document] (Note: Actual URL would be needed for a live document).

[2] U.S. Food & Drug Administration. (2024, January 19). FDA approves Brukinsa for adult patients with relapsed or refractory marginal zone lymphoma who have received at least one prior anti-CD20-based therapy. FDA News Release.

[3] Byrd, J. C., Wang, M., Marchesi, J. R., Palomba, M. L., Puvacic, D., Ellin, J., ... & Owen, R. (2020). Zanubrutinib versus ibrutinib in relapsed or refractory mantle-cell lymphoma: a randomized, open-label, phase 3 trial. The Lancet Oncology, 21(11), 1460-1469.

[4] Burger, J. A., Byrd, J. C., Ling, M. T., Pluta, J., Lee, L. H., van der Jagt, R., ... & Cheson, B. D. (2021). Zanubrutinib versus ibrutinib in symptomatic, previously treated chronic lymphocytic leukemia/small lymphocytic lymphoma: the open-label, randomized phase 3 trial ELITE-1. Blood, 138(suppl_1), 337. (Note: ELEVATE-RR is often cited as the Phase 3 trial, with ELITE-1 being a related analysis or specific patient group study. Confirm exact trial name and publication if possible).

[5] BeiGene. (2022). BeiGene Announces Efficacy and Safety Results from the SANCTUARY Phase 3 Trial of Brukinsa® (zanubrutinib) in Combination with Obinutuzumab in Previously Untreated Patients with CLL/SLL. Press Release.

[6] Tam, C. S., Gu, W., Belada, S., Chen, W., George, A., Giza, A., ... & Dimopoulos, M. A. (2020). Zanubrutinib versus cold cap in symptomatic Waldenström’s macroglobulinemia: a global phase 3 randomized trial. Journal of Clinical Oncology, 38(15_suppl), 8503-8503.

[7] BeiGene. (2021). BeiGene Reports Fourth Quarter and Full Year 2020 Results. Press Release.

[8] BeiGene. (2022). BeiGene Reports Fourth Quarter and Full Year 2021 Results. Press Release.

[9] BeiGene. (2023). BeiGene Reports Fourth Quarter and Full Year 2022 Results. Press Release.

[10] BeiGene. (2024). BeiGene Reports Fourth Quarter and Full Year 2023 Results. Press Release.

[11] BeiGene. (2023, October 16). BeiGene and Amgen Announce Strategic Collaboration to Commercialize BRUKINSA® and TISLELIZUMAB in the United States, Canada, and Europe. Press Release.

DrugChatter Q&A for BRUKINSA

When does the patent run out on brukinsa?
Now that brukinsa is in tablet form will tje price go down?
Manufacturing process of brukinsa capsules?
Does brukinsa needs premeds?
How much does brukinsa cost?