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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: 04/06/2012
Orphan Designation: Treatment of chronic lymphocytic leukemia (CLL)
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: 02/12/2014
Approved Labeled Indication: Treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
Exclusivity End Date: 02/12/2021 
Exclusivity Protected Indication* :  Treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy
2 Generic Name: ibrutinib
Trade Name: Imbruvica
Marketing Approval Date: 07/28/2014
Approved Labeled Indication: Treatment of patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy and treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion
Exclusivity End Date: 07/28/2021 
Exclusivity Protected Indication* :  Treatment of chronic lymphocytic leukemia with 17p deletion who have not received at least one prior therapy
3 Generic Name: ibrutinib
Trade Name: Imbruvica
Marketing Approval Date: 03/04/2016
Approved Labeled Indication: Indicated for the treatment of patients with chronic lymphocytic leukemia
Exclusivity End Date: 03/04/2023 
Exclusivity Protected Indication* :  Indicated for the treatment of patients with chronic lymphocytic leukemia without 17p deletion who have not received at least one prior therapy (first line therapy).

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