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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
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.
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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