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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ponatinib
Trade Name: Iclusig
Date Designated: 11/20/2009
Orphan Designation: Treatment of Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ALL)
Orphan Designation Status: Designated/Approved
Takeda Pharmaceuticals U.S.A., Inc.
40 Landsdowne Street
Cambridge, Massachusetts 02139
United States

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

Marketing approved:

1 Generic Name: ponatinib
Trade Name: Iclusig
Marketing Approval Date: 12/14/2012
Approved Labeled Indication: Treatment of adult patients with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) that is resistant or intolerant to prior tyrosine kinase inhibitor therapy.
Exclusivity End Date: 12/14/2019 
Exclusivity Protected Indication* :  
2 Generic Name: ponatinib
Trade Name: Iclusig
Marketing Approval Date: 03/19/2024
Approved Labeled Indication: treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy
Exclusivity End Date: 03/19/2031 
Exclusivity Protected Indication* :  treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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