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Search Orphan Drug Designations and Approvals

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Marketing approved:
Generic Name:	coagulation factor IX (recombinant); coagulation factor IX (recombinant)
Trade Name:	RIXUBIS; RIXUBIS
Date Designated:	10/31/2012
Orphan Designation:	Prophylactic use to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (routine prophylaxis in patients where there is no evidence or suspicion of bleeding)
Orphan Designation Status:	Designated/Approved
Sponsor:	Takeda Pharmaceuticals USA, Inc. 500 Kendall Street Cambridge, Massachusetts 02142 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	coagulation factor IX (recombinant); coagulation factor IX (recombinant)
	Trade Name:	RIXUBIS; RIXUBIS
	Marketing Approval Date:	06/26/2013
	Approved Labeled Indication:	Adults with Hemophilia B for (1) control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis to prevent or reduce the frequency of bleeding episodes.
	Exclusivity End Date:	06/26/2020
	Exclusivity Protected Indication* :	Adults with Hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes.

2	Generic Name:	coagulation factor IX (recombinant); coagulation factor IX (recombinant)
	Trade Name:	RIXUBIS; RIXUBIS
	Marketing Approval Date:	09/12/2014
	Approved Labeled Indication:	Adults and children with Hemophilia B for (1) control and prevention of bleeding episodes, (2) perioperative management, and (3) routine prophylaxis
	Exclusivity End Date:	09/12/2021
	Exclusivity Protected Indication* :	Children with hemophilia B for routine prophylaxis.

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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.

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