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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: tecovirimat
Trade Name: TPOXX
Date Designated: 12/27/2006
Orphan Designation: Treatment of smallpox
Orphan Designation Status: Designated/Approved
SIGA Technologies, Inc.
4575 SW Research Way
Suite 230
Corvallis, Oregon 97333
United States

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

Marketing approved:

1 Generic Name: tecovirimat
Trade Name: TPOXX
Marketing Approval Date: 07/13/2018
Approved Labeled Indication: TPOXX® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg.
Exclusivity End Date: 07/13/2025 
Exclusivity Protected Indication* :  TPOXX® is indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg.
2 Generic Name: tecovirimat
Trade Name: TPOXX
Marketing Approval Date: 05/18/2022
Approved Labeled Indication: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 3 kg
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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