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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ruxolitinib
Trade Name: JAKAFI
Date Designated: 11/03/2016
Orphan Designation: Treatment of graft versus host disease
Orphan Designation Status: Designated/Approved
Incyte Corporation
1801 Augustine Cut-Off
Wilmington, Delaware 19803
United States

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

Marketing approved:

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
3 Generic Name: ruxolitinib
Trade Name: Jakafi XR
Marketing Approval Date: 05/01/2026
Approved Labeled Indication: treatment of steroid-refractory acute graft-versus-host disease (aGVHD) in adult and pediatric patients 12 years and older; and 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: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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