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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: 02/02/2016
Orphan Designation: Treatment of patients with extranodal marginal zone lymphoma (mucosa associated lymphoid tissue [MALT type] 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: 01/18/2017
Approved Labeled Indication: Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.
Exclusivity End Date: 01/18/2024 
Exclusivity Protected Indication* :  Treatment of patients with Marginal Zone Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy.

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