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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: 11/08/2022
Orphan Designation: Treatment of follicular lymphoma
Orphan Designation Status: Designated/Approved
BeiGene, Ltd., c/o BeiGene USA, Inc.
1840 Gateway Drive, 3rd Floor
San Mateo, California 94404
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: 03/07/2024
Approved Labeled Indication: treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
Exclusivity End Date: 03/07/2031 
Exclusivity Protected Indication* :  treatment of adult patients with relapsed or refractory follicular lymphoma (FL), after two or more lines of systemic therapy
*Exclusivity Protected Indications are shown for approvals from 01/01/2013 to the present.
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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