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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	emicizumab-kxwh
Trade Name:	Hemlibra
Date Designated:	01/10/2014
Orphan Designation:	Treatment of hemophilia A
Orphan Designation Status:	Designated/Approved
Sponsor:	Genentech 1 DNA Way MS 355e South San Francisco, California 94080 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	emicizumab-kxwh
	Trade Name:	Hemlibra
	Marketing Approval Date:	11/16/2017
	Approved Labeled Indication:	Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors
	Exclusivity End Date:	11/16/2024
	Exclusivity Protected Indication* :	Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A (congenital factor VIII deficiency) with factor VIII inhibitors

2	Generic Name:	emicizumab-kxwh
	Trade Name:	Hemlibra
	Marketing Approval Date:	10/04/2018
	Approved Labeled Indication:	HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) with or without factor VIII inhibitors.
	Exclusivity End Date:	10/04/2025
	Exclusivity Protected Indication* :	HEMLIBRA is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients ages newborn and older with hemophilia A (congenital factor VIII deficiency) without factor VIII inhibitors.

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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