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Last Updated: January 26, 2023

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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Zanubrutinib has forty-nine patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for zanubrutinib
International Patents:49
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 30
Clinical Trials: 78
Patent Applications: 318
What excipients (inactive ingredients) are in zanubrutinib?zanubrutinib excipients list
DailyMed Link:zanubrutinib at DailyMed
Recent Clinical Trials for zanubrutinib

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

SponsorPhase
Genentech, Inc.Phase 2
University College, LondonPhase 2
Weill Medical College of Cornell UniversityPhase 2

See all zanubrutinib clinical trials

Pharmacology for zanubrutinib

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 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 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

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
Eurasian Patent Organization 201990519 КРИСТАЛЛИЧЕСКАЯ ФОРМА (S)-7-(1-АКРИЛОИЛПИПЕРИДИН-4-ИЛ)-2-(4-ФЕНОКСИФЕНИЛ)-4,5,6,7-ТЕТРАГИДРОПИРАЗОЛО[1,5-a]ПИРИМИДИН-3-КАРБОКСАМИДА, ЕЕ ПОЛУЧЕНИЕ И ПРИМЕНЕНИЯ See Plans and Pricing
Hungary E031980 See Plans and Pricing
Slovenia 2989106 See Plans and Pricing
Australia 2022200278 CRYSTALLINE FORM OF (S)-7-(1-ACRYLOYLPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL)-4,5,6,7-TETRA-HY DROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, PREPARATION, AND USES THEREOF 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-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
Cyprus 1118834 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for zanubrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2989106 C02989106/01 Switzerland See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67998 08.02.2022
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 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
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 122022000013 Germany See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106 2022C/508 Belgium See Plans and Pricing PRODUCT NAME: ZANUBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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