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Last Updated: December 25, 2024

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BRUKINSA Drug Patent Profile


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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

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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
Drug patent expirations by year for BRUKINSA
Drug Prices for BRUKINSA

See drug prices for BRUKINSA

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for BRUKINSA
Generic Entry Date for BRUKINSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Stichting Hemato-Oncologie voor Volwassenen NederlandPhase 2
International Extranodal Lymphoma Study Group (IELSG)Phase 3
City of Hope Medical CenterPhase 2

See all BRUKINSA clinical trials

Pharmacology for BRUKINSA
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRUKINSA is ⤷  Subscribe.

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
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes 11,896,596 ⤷  Subscribe ⤷  Subscribe
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes 11,142,528 ⤷  Subscribe Y ⤷  Subscribe
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes 9,447,106 ⤷  Subscribe Y Y ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

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

Patent: 17314178
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 22200278
Patent: CRYSTALLINE FORM OF (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL)-4,5,6,7-TETRA-HY DROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, PREPARATION, AND USES THEREOF
Estimated Expiration: ⤷  Subscribe

Patent: 24200030
Patent: 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
Estimated Expiration: ⤷  Subscribe

Brazil

Patent: 2019003205
Patent: forma cristalina de (s) -7- (1-acriloilpiperidin-4-il) -2- (4-fenoxifenil) -4,5,6,7-tetra-hidropirazol [1,5-a] pirimidina-3-carboxamida, sua preparação e seus usos
Estimated Expiration: ⤷  Subscribe

Canada

Patent: 33827
Patent: FORME CRISTALLINE DE (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYLE)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, SA PREPARATION ET SES UTILISATIONS (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)
Estimated Expiration: ⤷  Subscribe

China

Patent: 9563099
Estimated Expiration: ⤷  Subscribe

Patent: 6478165
Patent: 一种化合物的晶型、其制备和用途 (Crystal form of compound as well as preparation and application thereof)
Estimated Expiration: ⤷  Subscribe

Patent: 6478166
Patent: 一种化合物的晶型、其制备和用途 (Crystal form of compound as well as preparation and application thereof)
Estimated Expiration: ⤷  Subscribe

Eurasian Patent Organization

Patent: 1990519
Patent: КРИСТАЛЛИЧЕСКАЯ ФОРМА (S)-7-(1-АКРИЛОИЛПИПЕРИДИН-4-ИЛ)-2-(4-ФЕНОКСИФЕНИЛ)-4,5,6,7-ТЕТРАГИДРОПИРАЗОЛО[1,5-a]ПИРИМИДИН-3-КАРБОКСАМИДА, ЕЕ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЯ
Estimated Expiration: ⤷  Subscribe

European Patent Office

Patent: 00575
Patent: FORME CRISTALLINE DE (S)-7-(1-ACRYLOYLPIPÉRIDIN-4-YL)-2-(4-PHÉNOXYPHÉNYLE)-4,5,6,7-TÉTRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, SA PRÉPARATION ET SES UTILISATIONS (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)
Estimated Expiration: ⤷  Subscribe

Patent: 53322
Patent: 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)
Estimated Expiration: ⤷  Subscribe

Israel

Patent: 4784
Estimated Expiration: ⤷  Subscribe

Patent: 3319
Patent: מבנה גבישי של s)-7-(1-acryloylpiperidin-4-yl)-2-(4-) phenoxyphenyl)-4,5,6,7-tetra-hydropyrazolo(1,5-a)pyrimidine-3-carboxamide, שיטות הכנה ושימושים בו (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)
Estimated Expiration: ⤷  Subscribe

Japan

Patent: 02685
Estimated Expiration: ⤷  Subscribe

Patent: 13419
Estimated Expiration: ⤷  Subscribe

Patent: 19528276
Patent: (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
Estimated Expiration: ⤷  Subscribe

Patent: 22071072
Patent: (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
Estimated Expiration: ⤷  Subscribe

Patent: 24026550
Patent: (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
Estimated Expiration: ⤷  Subscribe

Mexico

Patent: 19001900
Patent: FORMA CRISTALINA DE (S)-7-(1-ACRILOILPIPERIDIN-4-IL)-2-(4-FENOXIFE NIL)-4,5,6,7-TETRA-HIDROPIRAZOLO[1,5-A]PIRIMIDIN-3-CARBOXAMIDA, PREPARACION Y USOS DE LA MISMA. (CRYSTALLINE FORM OF (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXY PHENYL)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMI DE, PREPARATION, AND USES THEREOF.)
Estimated Expiration: ⤷  Subscribe

New Zealand

Patent: 1418
Patent: 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
Estimated Expiration: ⤷  Subscribe

Singapore

Patent: 201901141W
Patent: 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
Estimated Expiration: ⤷  Subscribe

South Africa

Patent: 1900919
Patent: 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
Estimated Expiration: ⤷  Subscribe

South Korea

Patent: 2604975
Estimated Expiration: ⤷  Subscribe

Patent: 190032613
Estimated Expiration: ⤷  Subscribe

Patent: 230162137
Estimated Expiration: ⤷  Subscribe

Taiwan

Patent: 60356
Estimated Expiration: ⤷  Subscribe

Patent: 1811794
Patent: 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
Estimated Expiration: ⤷  Subscribe

Patent: 2233628
Patent: 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
Estimated Expiration: ⤷  Subscribe

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
Norway 2022005 ⤷  Subscribe
South Africa 201508504 FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS ⤷  Subscribe
Denmark 2989106 ⤷  Subscribe
Mexico 2015013481 COMPUESTOS HETEROCICLICOS FUSIONADOS COMO INHIBIDORES DE PROTEINA QUINASA. (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS.) ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRUKINSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2989106 CR 2022 00008 Denmark ⤷  Subscribe PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123
2989106 4/2022 Austria ⤷  Subscribe PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123
2989106 22C1010 France ⤷  Subscribe PRODUCT NAME: ZANUBRUTINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1576 20211123
2989106 122022000013 Germany ⤷  Subscribe PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

More… ↓

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