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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: 12/03/2012
Orphan Designation: Treatment of mantle cell 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: 11/13/2013
Approved Labeled Indication: Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Exclusivity End Date: 11/13/2020 
Exclusivity Protected Indication* :  Treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy

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