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 seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.Zanubrutinib has sixty patent family members in twenty-eight countries.
One supplier is listed for this compound.
Summary for zanubrutinib
International Patents: | 60 |
US Patents: | 7 |
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*:
Constraining patent/regulatory exclusivity:
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 |
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
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 | ||||
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
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 |
---|---|---|---|
Portugal | 2989106 | ⤷ Try a Trial | |
Croatia | P20170217 | ⤷ Try a Trial | |
Lithuania | PA2022504 | ⤷ Try a Trial | |
Eurasian Patent Organization | 201591908 | КОНДЕНСИРОВАННЫЕ ГЕТЕРОЦИКЛИЧЕСКИЕ СОЕДИНЕНИЯ В КАЧЕСТВЕ ИНГИБИТОРОВ ПРОТЕИНКИНАЗЫ | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for zanubrutinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2989106 | 4/2022 | Austria | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1576 (MITTEILUNG) 20211123 |
2989106 | 22C1010 | France | ⤷ Try a Trial | PRODUCT NAME: ZANUBRUTINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1576 20211123 |
2989106 | 301161 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT |
2989106 | C202230011 | Spain | ⤷ Try a Trial | 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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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