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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: inebilizumab-cdon
Trade Name: Uplizna
Date Designated: 05/01/2026
Orphan Designation: treatment of immunoglobulin G4-related disease
Orphan Designation Status: Designated/Approved
Horizon Therapeutics Ireland DAC
1 Horizon Way
Deerfield, Illinois 60015
United States

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

Marketing approved:

1 Generic Name: inebilizumab-cdon
Trade Name: Uplizna
Marketing Approval Date: 04/03/2025
Approved Labeled Indication: treatment of Immunoglobulin G4-related disease (IgG4-RD) in adult patients
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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