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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: deferiprone
Trade Name: Ferriprox
Date Designated: 12/12/2001
Orphan Designation: Treatment of iron overload in patients with hematologic disorders requiring chronic transfusion therapy
Orphan Designation Status: Designated/Approved
Chiesi USA, Inc.
175 Regency Woods Place
Suite 600
Cary, North Carolina 27518
United States

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

Marketing approved:

1 Generic Name: deferiprone
Trade Name: Ferriprox
Marketing Approval Date: 10/14/2011
Approved Labeled Indication: Treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate
Exclusivity End Date: 10/14/2018 
Exclusivity Protected Indication* :  
2 Generic Name: deferiprone
Trade Name: Ferriprox
Marketing Approval Date: 05/19/2020
Approved Labeled Indication: Ferriprox (deferiprone) is indicated for the treatment of patients with transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
Exclusivity End Date: N/A  
3 Generic Name: deferiprone
Trade Name: Ferriprox
Marketing Approval Date: 04/30/2021
Approved Labeled Indication: treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes; and treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias
Exclusivity End Date: 04/30/2028 
Exclusivity Protected Indication* :  treatment of transfusional iron overload in adult patients with thalassemia syndromes excluding adult patients covered by the indication for thalassemia syndromes approved on October 14, 2011; treatment of transfusional iron overload in pediatric patients 8 years of age and older with thalassemia syndromes; and treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with sickle cell disease or other anemias
4 Generic Name: deferiprone
Trade Name: Ferriprox
Marketing Approval Date: 04/30/2021
Approved Labeled Indication: treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with thalassemia syndromes; and treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with sickle cell disease or other anemias
Exclusivity End Date: 04/30/2028 
Exclusivity Protected Indication* :  treatment of transfusional iron overload in adult patients with thalassemia syndromes excluding adult patients covered by the indication for thalassemia syndromes approved on October 14, 2011; treatment of transfusional iron overload in pediatric patients 3 years of age and older with thalassemia syndromes; and treatment of transfusional iron overload in adult and pediatric patients 3 years of age and older with sickle cell disease or other anemias
*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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