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Last Updated: April 21, 2024

Zanubrutinib - Generic Drug Details


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What are the generic drug sources for zanubrutinib and what is the scope of freedom to operate?

Zanubrutinib is the generic ingredient in one branded drug marketed by Beigene and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zanubrutinib has sixty-one patent family members in twenty-eight countries.

One supplier is listed for this compound.

Summary for zanubrutinib
International Patents:61
US Patents:9
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 38
Clinical Trials: 88
Patent Applications: 371
What excipients (inactive ingredients) are in zanubrutinib?zanubrutinib excipients list
DailyMed Link:zanubrutinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for zanubrutinib
Generic Entry Date for zanubrutinib*:
Constraining patent/regulatory exclusivity:
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 zanubrutinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
International Extranodal Lymphoma Study Group (IELSG)Phase 3
City of Hope Medical CenterPhase 2
IpsenPhase 2

See all zanubrutinib clinical trials

Pharmacology for zanubrutinib
Paragraph IV (Patent) Challenges for ZANUBRUTINIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
BRUKINSA Capsules zanubrutinib 80 mg 213217 2 2023-11-14

US Patents and Regulatory Information for zanubrutinib

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 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
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 zanubrutinib

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 zanubrutinib

Country Patent Number Title Estimated Expiration
Singapore 11201506764W FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS ⤷  Try a Trial
Poland 2989106 ⤷  Try a Trial
Japan 6204568 ⤷  Try a Trial
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) ⤷  Try a Trial
European Patent Office 2989106 COMPOSÉS HÉTÉROCYCLIQUES FUSIONNÉS EN TANT QU'INHIBITEURS DE PROTÉINE KINASE (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018033853 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for zanubrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 2022C/508 Belgium ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2989106 4/2022 Austria ⤷  Try a Trial PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123
2989106 C02989106/01 Switzerland ⤷  Try a Trial FORMER OWNER: BEIGENE, LTD., KY
2989106 PA2022504 Lithuania ⤷  Try a Trial PRODUCT NAME: ZANUBRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
2989106 LUC00250 Luxembourg ⤷  Try a Trial PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND 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.