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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: ibrutinib
Trade Name: Imbruvica
Date Designated: 10/15/2013
Orphan Designation: Treatment of Waldenstrom's macroglobulinemia
Orphan Designation Status: Designated/Approved
Pharmacyclics, LLC
995 E. Arques Avenue
Sunnyvale, California 94085
United States

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

Marketing approved:

1 Generic Name: ibrutinib
Trade Name: Imbruvica
Marketing Approval Date: 01/29/2015
Approved Labeled Indication: Treatment of patients with Waldenstrom's macroglobulinemia
Exclusivity End Date: 01/29/2022 
Exclusivity Protected Indication* :  Treatment of patients with Waldenstrom's macroglobulinemia

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