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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: brincidofovir
Trade Name: Tembexa
Date Designated: 06/05/2018
Orphan Designation: Treatment of smallpox
Orphan Designation Status: Designated/Approved
Emergent BioDefense Operations Lansing LLC
3500 North Martin Luther King Jr. Blvd.
Lansing , Michigan 48906
United States

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

Marketing approved:

1 Generic Name: brincidofovir
Trade Name: Tembexa
Marketing Approval Date: 06/04/2021
Approved Labeled Indication: Treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates
Exclusivity End Date: 06/04/2028 
Exclusivity Protected Indication* :  Treatment of human smallpox disease caused by variola virus in adult and pediatric patients, including neonates
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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