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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: Coagulation factor X (human)
Trade Name: COAGADEX
Date Designated: 11/08/2007
Orphan Designation: Treatment of hereditary factor X deficiency
Orphan Designation Status: Designated/Approved
Bio Products Laboratory Limited
Dagger Lane
Elstree, Hertfordshire
United Kingdom

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

Marketing approved:

1 Generic Name: Coagulation factor X (human)
Trade Name: COAGADEX
Marketing Approval Date: 10/20/2015
Approved Labeled Indication: Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency
Exclusivity End Date: 10/20/2022 
Exclusivity Protected Indication* :  Treatment of adults and adolescents (aged 12 years and above) with hereditary Factor X deficiency for on-demand treatment and control of bleeding episodes and perioperative management of bleeding in patients with mild hereditary Factor X deficiency
2 Generic Name: Coagulation factor X (human)
Trade Name: COAGADEX
Marketing Approval Date: 09/21/2018
Approved Labeled Indication: COAGADEX is indicated in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with mild and moderate hereditary Factor X deficiency.
Exclusivity End Date: 09/21/2025 
Exclusivity Protected Indication* :  Coagadex is indicated for routine prophylaxis to reduce the frequency of bleeding episodes in adults and children with hereditary Factor X deficiency; on-demand treatment and control of bleeding episodes in children under the age of 12 years with hereditary Factor X deficiency; perioperative management of bleeding in children under the age of 12 years with mild hereditary factor X deficiency; perioperative management of bleeding in adults and children with moderate hereditary Factor X deficiency
3 Generic Name: Coagulation factor X (human)
Trade Name: Coagadex
Marketing Approval Date: 04/14/2023
Approved Labeled Indication: in adults and children with hereditary Factor X deficiency for routine prophylaxis to reduce the frequency of bleeding episodes; on-demand treatment and control of bleeding episodes; and perioperative management of bleeding in patients with mild, moderate, and severe hereditary Factor X deficiency
Exclusivity End Date: 04/14/2030 
Exclusivity Protected Indication* :  perioperative management of bleeding in adults and children with severe hereditary Factor X deficiency
*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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