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Brukinsa is a drug marketed by Beigene and is included in one NDA. There is one patent protecting this drug.
This drug has twenty-seven patent family members in twenty-four countries.
The generic ingredient in BRUKINSA is zanubrutinib. One supplier is listed for this compound. Additional details are available on the zanubrutinib profile page.
Brukinsa will be eligible for patent challenges on November 14th, 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 April 22nd, 2034. This may change due to patent challenges or generic licensing.
Generic Entry Opportunity Date for BRUKINSA
*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.
|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||Start Trial||Start Trial||Y||Y||Start Trial|
|Beigene||BRUKINSA||zanubrutinib||CAPSULE;ORAL||213217-001||Nov 14, 2019||RX||Yes||Yes||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|