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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: 02/05/2015
Orphan Designation: Treatment of splenic marginal zone lymphoma
Orphan Designation Status: Designated/Approved
Pharmacyclics, LLC
1000 Gateway Blvd
South San Francisco, California 94080
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Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn)
Exclusivity End Date: 05/18/2023 
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Lymphoma (MZL) who require systemic therapy and have received at least one prior anti-CD20-based therapy (indication withdrawn)

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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