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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: zanubrutinib
Trade Name: Brukinsa
Date Designated: 08/24/2020
Orphan Designation: Treatment of splenic marginal zone lymphoma
Orphan Designation Status: Designated/Approved
BeiGene USA, Inc.
2955 Campus Drive
Suite 200
San Mateo, California 94403
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: zanubrutinib
Trade Name: Brukinsa
Marketing Approval Date: 09/14/2021
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
Exclusivity End Date: 09/14/2028 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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