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
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 |


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
Sponsor | Phase |
---|---|
Northwestern University | Phase 2 |
Jennifer R. Brown, MD, PhD | Phase 2 |
Yazeed Sawalha | Phase 1 |
Anatomical Therapeutic Chemical (ATC) Classes for BRUKINSA
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
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 |