Search Orphan Drug Designations and Approvals

Marketing approved:
Generic Name:	ruxolitinib
Trade Name:	JAKAFI
Date Designated:	11/03/2016
Orphan Designation:	Treatment of graft versus host disease
Orphan Designation Status:	Designated/Approved
Sponsor:	Incyte Corporation 1801 Augustine Cut-Off Wilmington, Delaware 19803 United States The sponsor address listed is the last reported by the sponsor to OOPD.

1	Generic Name:	ruxolitinib
	Trade Name:	JAKAFI
	Marketing Approval Date:	05/24/2019
	Approved Labeled Indication:	Treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.
	Exclusivity End Date:	05/24/2026
	Exclusivity Protected Indication* :	Treatment of steroid-refractory acute graft-versus-host disease (GVHD) in adult and pediatric patients 12 years and older.

2	Generic Name:	ruxolitinib
	Trade Name:	Jakafi
	Marketing Approval Date:	09/22/2021
	Approved Labeled Indication:	Treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older
	Exclusivity End Date:	09/22/2028
	Exclusivity Protected Indication* :	Treatment of chronic graft-versus-host disease (cGVHD) after failure of one or two lines of systemic therapy in adult and pediatric patients 12 years and older

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.