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BRUKINSA Drug Profile
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» See Plans and PricingWhen 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
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 |
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
| Sponsor | Phase |
|---|---|
| BeiGene | Phase 2 |
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 |
International Patents for BRUKINSA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Canada | 2902686 | Start Trial |
| Spain | 2619125 | Start Trial |
| Eurasian Patent Organization | 028756 | Start Trial |
| Eurasian Patent Organization | 201591908 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
