BRUKINSA Drug Patent Profile

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 four patents protecting this drug.

This drug has forty-four patent family members in twenty-six countries.

The generic ingredient in BRUKINSA is zanubrutinib. 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:	44
US Patents:	4
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	17
Patent Applications:	53
Drug Prices:	Drug price information for BRUKINSA
What excipients (inactive ingredients) are in BRUKINSA?	BRUKINSA excipients list
DailyMed Link:	BRUKINSA at DailyMed

See drug prices for BRUKINSA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for BRUKINSA

NDA:

213217

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
Northwestern University	Phase 2
Jennifer R. Brown, MD, PhD	Phase 2
Yazeed Sawalha	Phase 1

See all BRUKINSA clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for BRUKINSA

L01EL	Bruton's tyrosine kinase (BTK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for BRUKINSA

BRUKINSA is protected by ten US patents and six FDA Regulatory Exclusivities.

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

FDA Regulatory Exclusivity protecting BRUKINSA

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

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

Brazil

Canada

China

Eurasian Patent Organization

European Patent Office

Japan

Mexico

Singapore

South Africa

South Korea

Taiwan

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
Croatia	P20170217
Serbia	55770	FUZIONISANA HETEROCIKLIČNA JEDINJENJA KAO INHIBITORI PROTEIN KINAZE (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS)
Mexico	367918	COMPUESTOS HETEROCICLICOS FUSIONADOS COMO INHIBIDORES DE PROTEINA QUINASA. (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS.)
Brazil	112015025260	compostos heterocíclicos fundidos como inibidores da proteína quinase
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-ACRYLOYLIPIPERIDIN-4-YL)-2-(4-PHENOXYPHENYL)-4,5,6,7-TETRA-HYDROPYRAZOLO[1,5-A]PYRIMIDINE-3-CARBOXAMIDE,PREPARATION, AND USES THEREOF)
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.)

Supplementary Protection Certificates for BRUKINSA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2989106	LUC00250	Luxembourg		PRODUCT NAME: ZANUBRUTINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1576 20211123
2989106	122022000013	Germany		PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 20211122
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
2989106	301161	Netherlands		PRODUCT NAME: ZANUBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1576 20211123