Zanubrutinib - Generic Drug Details

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

Zanubrutinib has fifty patent family members in twenty-seven countries.

One supplier is listed for this compound.

Summary for zanubrutinib

International Patents:	50
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	31
Clinical Trials:	81
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

Sponsor	Phase
City of Hope Medical Center	Phase 2
BeiGene	Phase 2/Phase 3
Weill Medical College of Cornell University	Phase 2

See all zanubrutinib clinical trials

Pharmacology for zanubrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Bruton's Tyrosine Kinase Inhibitors

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			Y
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes
Beigene	BRUKINSA	zanubrutinib	CAPSULE;ORAL	213217-001	Nov 14, 2019		RX	Yes	Yes

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

International Patents for zanubrutinib

Country	Patent Number	Title	Estimated Expiration
South Korea	20160002812	단백질 키나제 억제제로서의 융합된 헤테로시클릭 화합물 (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS)
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)
Mexico	2015013481	COMPUESTOS HETEROCICLICOS FUSIONADOS COMO INHIBIDORES DE PROTEINA QUINASA. (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS.)
European Patent Office	3500575	FORME CRISTALLINE DE (S)-7-(1-ACRYLOYLPIPÉRIDIN-4-YL)-2-(4-PHÉNOXYPHÉNYLE)-4,5,6,7-TÉTRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE, SA PRÉPARATION 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)
South Korea	101793807
New Zealand	711540	Fused heterocyclic compounds as protein kinase inhibitors

Supplementary Protection Certificates for zanubrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2989106	122022000013	Germany		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
2989106	C02989106/01	Switzerland		PRODUCT NAME: ZANUBRUTINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 67998 08.02.2022
2989106	2022C/508	Belgium		PRODUCT NAME: ZANUBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
2989106	LUC00250	Luxembourg		PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
2989106	PA2022504	Lithuania		PRODUCT NAME: ZANUBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
2989106	CA 2022 00008	Denmark		PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 20211123