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Last Updated: July 6, 2020

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BRUKINSA Drug Profile


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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 is one patent protecting this drug.

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

The generic ingredient in BRUKINSA is zanubrutinib. Additional details are available on the zanubrutinib profile page.

US ANDA Litigation and 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 April 22, 2034. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for BRUKINSA
International Patents:28
US Patents:1
Applicants:1
NDAs:1
Bulk Api Vendors: 15
Clinical Trials: 1
Patent Applications: 3
Drug Prices: Drug price information for BRUKINSA
DailyMed Link:BRUKINSA at DailyMed
Drug patent expirations by year for BRUKINSA
Drug Prices for BRUKINSA

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Generic Entry Opportunity Date for BRUKINSA
Generic Entry Date for BRUKINSA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
BeiGenePhase 2

See all BRUKINSA clinical trials

US Patents and Regulatory Information for 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   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
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

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Serving leading biopharmaceutical companies globally:

Baxter
Dow
Merck
Express Scripts
Johnson and Johnson
Medtronic

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.