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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: duvelisib
Trade Name: COPIKTRA
Date Designated: 04/15/2013
Orphan Designation: Treatment of chronic lymphocytic leukemia and small lymphocytic lymphoma
Orphan Designation Status: Designated/Approved
Secura Bio, Inc.
1995 Village Center Cir.
Las Vegas, Nevada 89134-6360
United States

The sponsor address listed is the last reported by the sponsor to OOPD.

Marketing approved:

1 Generic Name: duvelisib
Trade Name: COPIKTRA
Marketing Approval Date: 09/24/2018
Approved Labeled Indication: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies
Exclusivity End Date: 09/24/2025 
Exclusivity Protected Indication* :  Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior therapies
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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