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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: golimumab
Trade Name: Simponi
Date Designated: 03/16/2012
Orphan Designation: Treatment of pediatric ulcerative colitis
Orphan Designation Status: Designated/Approved
Janssen Biotech, Inc.
1400 McKean Road
Spring House, Pennsylvania 19477
United States

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

Marketing approved:

1 Generic Name: golimumab
Trade Name: Simponi
Marketing Approval Date: 10/07/2025
Approved Labeled Indication: treatment of adults and pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis
Exclusivity End Date: 10/07/2032 
Exclusivity Protected Indication* :  treatment of pediatric patients weighing at least 15 kg with moderately to severely active ulcerative colitis
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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