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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: atoltivimab, maftivimab, and odesivimab-ebgn
Trade Name: INMAZEB™
Date Designated: 07/14/2016
Orphan Designation: Treatment of ebola virus infection
Orphan Designation Status: Designated/Approved
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
United States

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

Marketing approved:

1 Generic Name: atoltivimab, maftivimab, and odesivimab-ebgn
Trade Name: INMAZEB™
Marketing Approval Date: 10/14/2020
Approved Labeled Indication: treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
Exclusivity End Date: 10/14/2027 
Exclusivity Protected Indication* :  treatment of infection caused by Zaire ebolavirus in adult and pediatric patients, including neonates born to a mother who is RT-PCR positive for Zaire ebolavirus infection
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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