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Last Updated: April 22, 2024

Zanubrutinib - Generic Drug Details


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What are the generic 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 ⤷  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
>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
Australia 2024200030 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
Lithuania PA2022504 ⤷  Try a Trial
South Africa 201900919 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
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) ⤷  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 22C1010 France ⤷  Try a Trial PRODUCT NAME: ZANUBRUTINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1576 20211123
2989106 301161 Netherlands ⤷  Try a Trial DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2989106 122022000013 Germany ⤷  Try a Trial PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
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
>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.