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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: 05/30/2013
Orphan Designation: Treatment of small lymphocytic lymphoma
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: 05/06/2016
Approved Labeled Indication: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and indicated for the treatment of patients with chronic lymphocytic leukemia (CLL)/small lymphocytic leukemia (SLL) with 17p deletion.
Exclusivity End Date: 05/06/2023 
Exclusivity Protected Indication* :  For treatment of patients with small lymphocytic lymphoma (SLL)

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