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BRUKINSA Drug Patent Profile

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

Brukinsa is a drug marketed by Beigene and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty 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:	73
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	28
Patent Applications:	80
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

^*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
International Extranodal Lymphoma Study Group (IELSG)	Phase 3
City of Hope Medical Center	Phase 2

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-eight US patents and ten 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
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			Y
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes			Y	Y
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes			Y	Y
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes			Y	Y
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes

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/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 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
Taiwan	I760356
European Patent Office	4353322	FORME CRISTALLINE DU (S)-7-(1-ACRYLOYLPIPÉRIDIN-4-YL)-2-(4-PHÉNOXYPHÉNYL)-4,5,6,7-TÉTRA-HYDROPYRAZOLO[1,5-A!PYRIMIDINE-3-CARBOXAMIDE, PRÉPARATION ET UTILISATIONS ASSOCIÉES (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)
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)
Australia	2024200030	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
China	109563099	(S)-7-(1-丙烯酰基哌啶-4-基)-2-(4-苯氧基苯基)-4,5,6,7-四氢吡唑并[1,5-A]嘧啶-3-甲酰胺的晶型、其制备和用途 (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	2024026550	（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
Hungary	S2200010

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	2022C/508	Belgium		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2989106	PA2022504	Lithuania		PRODUCT NAME: ZANUBRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
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	CA 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), ASSIGNMENT
2989106	LUC00250	Luxembourg		PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123

BRUKINSA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Drug: BRUKINSA

Introduction

BRUKINSA, developed by BeiGene, is a groundbreaking medication in the treatment of blood cancers, particularly acute lymphoblastic leukemia (ALL) and chronic lymphocytic leukemia (CLL). This article delves into the market dynamics and financial trajectory of BRUKINSA, highlighting its growth, competitive landscape, and financial performance.

Approval and Indications

BRUKINSA (zanubrutinib) was approved by the FDA in January 2023 for the treatment of chronic lymphocytic leukemia (CLL)[4].

• This approval marked a significant milestone, positioning BRUKINSA as a key player in the hematology-oncology market.

Market Growth

The market for BRUKINSA is experiencing rapid growth driven by several factors:

Increasing Prevalence of ALL and CLL

• The global market for BRUKINSA is expected to grow significantly due to the increasing prevalence of ALL and CLL, especially in developing countries[1].

Efficacy and Safety

• BRUKINSA's efficacy and safety have been well-documented, making it an attractive treatment option for patients with CLL and ALL. The drug works by inhibiting the BCL-2 protein, which is involved in the regulation of cell death[1].

Regional Dominance

• The Asia Pacific region is a major market for BRUKINSA, driven by the large population and increasing demand for effective treatment options for ALL and CLL[1].

Financial Performance

Revenue Growth

• In the second quarter of 2024, BRUKINSA's global revenue reached $929 million, with U.S. sales growing by 114% and European sales by 209% compared to the same period in 2023[2].
• By the third quarter of 2024, global revenue for BRUKINSA had increased to $690 million, with U.S. sales of $504 million (87% growth) and European sales of $97 million (217% growth)[3].

Quarterly Financial Highlights

• For the first quarter of 2024, U.S. sales of BRUKINSA totaled $351 million, representing a 153% growth over the prior-year period. European sales were $67 million, with a 243% growth driven by additional reimbursements and market share gains[5].

Gross Margin and Operating Expenses

• The gross margin for BRUKINSA as a percentage of global product revenue was 85% in the second quarter of 2024, up from 83% in the prior-year period. This increase was due to a higher sales mix of BRUKINSA compared to other products[2].
• Selling, General and Administrative (SG&A) expenses increased due to continued investment in the global commercial launch of BRUKINSA, particularly in the U.S. and Europe[2][5].

Operating Income and Cash Flow

• Despite increased SG&A expenses, BeiGene achieved positive non-GAAP operating income in the second quarter of 2024, with a significant reduction in GAAP operating loss. The company also generated substantial cash flow from operations, indicating strong financial health[2][3].

Competitive Landscape

Market Share and Adoption

• BRUKINSA has demonstrated remarkable growth, with a 149% increase in sales from 2022 to 2023. This growth has come at the expense of other drugs like IMBRUVICA, which saw a decline in patient counts[4].
• By 2023, BRUKINSA had emerged as a leader in the BTKi class for new-patient share in relapsed or refractory CLL[5].

Key Players

• The market is highly competitive, with key players including Bristol Myers Squibb, Celgene, Novartis, Pfizer, and Merck. However, BeiGene's strategic investments and strong product performance have positioned BRUKINSA favorably[1].

Clinical Outcomes and Safety

Sustained Progression-Free Survival

• Five-year follow-up results from the Phase 3 SEQUOIA study showed sustained progression-free survival (PFS) benefits with BRUKINSA in patients with treatment-naïve CLL or small lymphocytic lymphoma (SLL), with no new safety signals observed[3].

Demographic Insights

• Demographic analysis indicates that BRUKINSA is more commonly prescribed to non-Hispanic White males, aligning with the higher incidence rates of blood cancers in these demographics[4].

End-User Segmentation

Clinics and Hospitals

• Clinics are expected to grow with a high CAGR during the forecast period, driven by the increasing demand for effective treatment options for ALL and CLL. Hospitals also play a significant role, but clinics are anticipated to be the faster-growing segment[1].

Regional Analysis

Asia Pacific

• The Asia Pacific region dominated the BRUKINSA market in 2022 and is expected to continue growing significantly due to the large population and increasing prevalence of ALL and CLL[1].

U.S. and Europe

• The U.S. and European markets have seen substantial growth in BRUKINSA sales, driven by expanded use in CLL and increased market share across major markets[3][5].

Future Outlook

Continued Growth

• The global BRUKINSA market is expected to grow at a strong CAGR of around 6% during the forecast period (2023-2030), driven by the increasing demand for effective treatment options and the growing awareness of the drug’s efficacy and safety[1].

Expansion of Indications

• BRUKINSA is expected to gain additional approvals for other indications such as Waldenström’s macroglobulinemia (WM) and marginal zone lymphoma, further expanding its market potential[5].

Key Takeaways

• BRUKINSA has shown remarkable growth since its approval, driven by its efficacy and safety in treating CLL and ALL.
• The drug has gained significant market share, particularly in the U.S. and Europe.
• The Asia Pacific region is a key market due to its large population and increasing demand for effective treatments.
• BeiGene’s financial performance has improved significantly, with positive non-GAAP operating income and substantial cash flow.
• The competitive landscape is dynamic, with BRUKINSA emerging as a leader in the BTKi class.

FAQs

What is BRUKINSA used for?

BRUKINSA (zanubrutinib) is used to treat chronic lymphocytic leukemia (CLL) and acute lymphoblastic leukemia (ALL), types of blood cancers.

Who is the manufacturer of BRUKINSA?

BRUKINSA is developed and marketed by BeiGene.

What is the expected market growth for BRUKINSA?

The global BRUKINSA market is expected to grow at a CAGR of around 6% during the forecast period (2023-2030)[1].

How has BRUKINSA performed financially?

BRUKINSA has shown significant revenue growth, with U.S. sales growing by 153% and European sales by 243% in the first quarter of 2024 compared to the prior year. The drug has also contributed to BeiGene achieving positive non-GAAP operating income[2][5].

What are the key regions driving the growth of BRUKINSA?

The Asia Pacific region, along with the U.S. and Europe, are the key regions driving the growth of BRUKINSA due to their large populations and increasing demand for effective treatments[1][3].

Sources

1. UnivDatos: Brukinsa Market: Current Analysis and Forecast (2023-2030)
2. BusinessWire: BeiGene Enters Next Phase of Global Growth with Announcement of Second Quarter 2024 Financial Results and Corporate Updates
3. StockTitan: BeiGene Announces Third Quarter 2024 Financial Results and Corporate Updates
4. Komodo Health: Drug Snapshot: Shifting Paradigms in Hematology-Oncology
5. BeiGene IR: BeiGene Reports First Quarter 2024 Financial Results and Business Updates