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 five patents protecting this drug.
This drug has fifty-four patent family members in twenty-eight 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 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: | 54 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 35 |
| Clinical Trials: | 27 |
| Patent Applications: | 89 |
| Drug Prices: | Drug price information for BRUKINSA |
| What excipients (inactive ingredients) are in BRUKINSA? | BRUKINSA excipients list |
| DailyMed Link: | BRUKINSA at DailyMed |
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
| Sponsor | Phase |
|---|---|
| International Extranodal Lymphoma Study Group (IELSG) | Phase 3 |
| City of Hope Medical Center | Phase 2 |
| Incyte Corporation | Phase 2 |
Pharmacology for BRUKINSA
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Bruton's Tyrosine Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for BRUKINSA
US Patents and Regulatory Information for BRUKINSA
BRUKINSA is protected by twenty-five US patents and eight FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of BRUKINSA is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Substituted pyrazolo[1,5-a]pyrimidines as Bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE TREATMENT OF PATIENTS WITH WALDENSTROM'S MACROGLOBULINEMIA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA
Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA
Substituted pyrazolo[1,5-a]pyrimidines as bruton's tyrosine kinase modulators
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA
FDA Regulatory Exclusivity protecting BRUKINSA
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH WALDENSTROM’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷ Try a Trial
INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH WALDENSTRӦM’S MACROGLOBULINEMIA (WM)
Exclusivity Expiration: ⤷ Try a Trial
TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN
Exclusivity Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Beigene | BRUKINSA | zanubrutinib | CAPSULE;ORAL | 213217-001 | Nov 14, 2019 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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
Estimated Expiration: ⤷ Try a Trial
Patent: 22200278
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2019003205
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 33827
Estimated Expiration: ⤷ Try a Trial
China
Patent: 9563099
Estimated Expiration: ⤷ Try a Trial
Patent: 6478165
Estimated Expiration: ⤷ Try a Trial
Patent: 6478166
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 1990519
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 00575
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 4784
Estimated Expiration: ⤷ Try a Trial
Patent: 3319
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 19528276
Estimated Expiration: ⤷ Try a Trial
Patent: 22071072
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 19001900
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1418
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201901141W
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1900919
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 190032613
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 60356
Estimated Expiration: ⤷ Try a Trial
Patent: 1811794
Estimated Expiration: ⤷ Try a Trial
Patent: 2233628
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| 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-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL )-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE,PREPARATION, AND USES THEREOF) | ⤷ Try a Trial |
| Singapore | 11201506764W | FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS | ⤷ Try a Trial |
| Spain | 2619125 | ⤷ Try a Trial | |
| Singapore | 11201901141W | 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 | ⤷ Try a Trial |
| Slovenia | 2989106 | ⤷ Try a Trial | |
| Poland | 2989106 | ⤷ Try a Trial | |
| Japan | 2016521273 | タンパク質キナーゼ阻害剤としての縮合複素環化合物 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for BRUKINSA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2989106 | 122022000013 | Germany | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122 |
| 2989106 | CA 2022 00008 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123 |
| 2989106 | C202230011 | Spain | ⤷ Try a Trial | 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 | C02989106/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67998 08.02.2022 |
| 2989106 | PA2022504 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121 |
| 2989106 | 2022C/508 | Belgium | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123 |
| 2989106 | 22C1010 | France | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; 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.
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