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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: upadacitinib
Trade Name: Rinvoq
Date Designated: 09/18/2015
Orphan Designation: Treatment of pediatric (aged 0 through 16 years) juvenile idiopathic arthritis (JIA) ILAR categories excluding systemic JIA
Orphan Designation Status: Designated/Approved
AbbVie, Inc.
1 North Waukegan Road
North Chicago, Illinois 60064
United States

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

Marketing approved:

1 Generic Name: upadacitinib
Trade Name: Rinvoq
Marketing Approval Date: 04/26/2024
Approved Labeled Indication: treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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