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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name: teprotumumab
Trade Name:
Date Designated: 05/06/2013
Orphan Designation: Treatment of active thyroid eye disease
Orphan Designation Status: Designated/Approved
Horizon Therapeutics Ireland DAC
Connaught House, 1st Floor
1 Burlington Road
Dublin , Ireland DO4 C5Y6

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

Marketing approved:

1 Generic Name: teprotumumab
Trade Name:
Marketing Approval Date: 01/21/2020
Approved Labeled Indication: TEPEZZA is indicated for the treatment of Thyroid Eye Disease.
Exclusivity End Date: 01/21/2027 
Exclusivity Protected Indication* :  For the treatment of active Thyroid Eye Disease

*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.