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Last Updated: May 19, 2022

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 four patents protecting this drug.

This drug has forty-four patent family members in twenty-six countries.

The generic ingredient in BRUKINSA is zanubrutinib. Additional details are available on the zanubrutinib profile page.

DrugPatentWatch® Generic Entry Outlook for Brukinsa

Brukinsa will be eligible for patent challenges on November 14, 2023. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for BRUKINSA
International Patents:44
US Patents:4
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 27
Clinical Trials: 17
Patent Applications: 53
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 Generic Entry Opportunity 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
Northwestern UniversityPhase 2
Jennifer R. Brown, MD, PhDPhase 2
Yazeed SawalhaPhase 1

See all BRUKINSA clinical trials

US Patents and Regulatory Information for BRUKINSA

BRUKINSA is protected by ten US patents and six FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRUKINSA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting BRUKINSA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Crystalline form of (S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxyphenyl)-4,5,6,7-tetra-hydrop- yrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA

Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN

FDA Regulatory Exclusivity protecting BRUKINSA

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH WALDENSTR¿M’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: See Plans and Pricing

TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Beigene BRUKINSA zanubrutinib CAPSULE;ORAL 213217-001 Nov 14, 2019 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
Estimated Expiration: See Plans and Pricing

Patent: 22200278
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2019003205
Estimated Expiration: See Plans and Pricing

Canada

Patent: 33827
Estimated Expiration: See Plans and Pricing

China

Patent: 9563099
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1990519
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 00575
Estimated Expiration: See Plans and Pricing

Japan

Patent: 19528276
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 19001900
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201901141W
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1900919
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 190032613
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 1811794
Estimated Expiration: See Plans and Pricing

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
Croatia P20170217 See Plans and Pricing
Serbia 55770 FUZIONISANA HETEROCIKLIČNA JEDINJENJA KAO INHIBITORI PROTEIN KINAZE (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS) See Plans and Pricing
Mexico 367918 COMPUESTOS HETEROCICLICOS FUSIONADOS COMO INHIBIDORES DE PROTEINA QUINASA. (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS.) See Plans and Pricing
Brazil 112015025260 compostos heterocíclicos fundidos como inibidores da proteína quinase See Plans and Pricing
Canada 3033827 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-ACRYLOYLIPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE,PREPARATION, AND USES THEREOF) See Plans and Pricing
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) See Plans and Pricing
Mexico 2015013481 COMPUESTOS HETEROCICLICOS FUSIONADOS COMO INHIBIDORES DE PROTEINA QUINASA. (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS.) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for BRUKINSA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2989106 LUC00250 Luxembourg See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
2989106 122022000013 Germany See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106 PA2022504 Lithuania See Plans and Pricing PRODUCT NAME: ZANUBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
2989106 CA 2022 00008 Denmark See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123
2989106 301161 Netherlands See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1576 20211123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.