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

Zanubrutinib has seventy-three patent family members in thirty countries.

One supplier is listed for this compound.

Summary for zanubrutinib

International Patents:	73
US Patents:	12
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	96
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^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Sponsor	Phase
University Health Network, Toronto	Phase 2
MorphoSys AG	Phase 1/Phase 2
Incyte Corporation	Phase 1/Phase 2

See all zanubrutinib clinical trials

Pharmacology for zanubrutinib

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

Anatomical Therapeutic Chemical (ATC) Classes for zanubrutinib

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

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

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Glossary

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

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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

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Country	Patent Number	Title	Estimated Expiration
Japan	2019528276	（Ｓ）−７−（１−アクリロイルピペリジン−４−イル）−２−（４−フェノキシフェニル）−４，５，６，７−テトラ−ヒドロピラゾロ［１，５−Ａ］ピリミジン−３−カルボキサミドの結晶形、その調製、及びその使用	⤷ Sign Up
Israel	264784		⤷ Sign Up
China	110087680	使用包含BTK抑制剂的组合产品治疗癌症 (USE OF COMBINATION COMPRISING BTK INHIBITOR FOR TREATING CANCERS)	⤷ Sign Up
Eurasian Patent Organization	028756	КОНДЕНСИРОВАННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ (FUSED HETEROCYCLIC COMPOUNDS AS PROTEIN KINASE INHIBITORS)	⤷ Sign Up
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)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for zanubrutinib

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2989106	SPC/GB22/006	United Kingdom	⤷ Sign Up	PRODUCT NAME: ZANUBRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/21/1576 (NI) 20211122; UK FURTHER MA ON IPSUM 20211122
2989106	4/2022	Austria	⤷ Sign Up	PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123
2989106	C202230011	Spain	⤷ Sign Up	PRODUCT NAME: ZANUBRUTINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1576; DATE OF AUTHORISATION: 20211122; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1576; DATE OF FIRST AUTHORISATION IN EEA: 20211122
2989106	301161	Netherlands	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
2989106	2290500-4	Sweden	⤷ Sign Up	PRODUCT NAME: ZANUBRUTINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REG. NO/DATE: EU/1/21/1576 20211123
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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