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Last Updated: April 24, 2024

ZANUBRUTINIB - Generic Drug Details

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What are the generic sources for zanubrutinib and what is the scope of patent protection?

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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
International Extranodal Lymphoma Study Group (IELSG)	Phase 3
City of Hope Medical Center	Phase 2
Ipsen	Phase 2

See all ZANUBRUTINIB clinical trials

Pharmacology for ZANUBRUTINIB

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

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	⤷ 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
>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
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	⤷ Try a Trial
New Zealand	711540	Fused heterocyclic compounds as protein kinase inhibitors	⤷ Try a Trial
Lithuania	2989106		⤷ Try a Trial
>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	C02989106/01	Switzerland	⤷ Try a Trial	FORMER OWNER: BEIGENE, LTD., KY
2989106	PA2022504	Lithuania	⤷ Try a Trial	PRODUCT NAME: ZANUBRUTINIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA ; REGISTRATION NO/DATE: EU/1/21/1576 20211121
2989106	CA 2022 00008	Denmark	⤷ Try a Trial	PRODUCT NAME: ZANUBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/21/1576 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.