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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: C1 esterase inhibitor (human)
Trade Name: Berinert
Date Designated: 10/16/1992
Orphan Designation: Prevention and/or treatment of acute attacks of hereditary angioedema.
Orphan Designation Status: Designated/Approved
CSL Behring LLC
1020 First Avenue
PO Box 61501
King of Prussia, Pennsylvania 19406
United States

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

Marketing approved:

1 Generic Name: C1 esterase inhibitor (human)
Trade Name: Berinert
Marketing Approval Date: 10/08/2009
Approved Labeled Indication: Treatment of acute attacks of hereditary angioedema.
Exclusivity End Date: 10/08/2016 
Exclusivity Protected Indication* :  
2 Generic Name: C1 esterase inhibitor subcutaneous (human)
Trade Name: Haegarda
Marketing Approval Date: 06/22/2017
Approved Labeled Indication: For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
Exclusivity End Date: 06/22/2024 
Exclusivity Protected Indication* :  For routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients.
3 Generic Name: C1 esterase inhibitor subcutaneous (human)
Trade Name: Haegarda
Marketing Approval Date: 09/24/2020
Approved Labeled Indication: HAEGARDA is a plasma-derived concentrate of C1 Esterase Inhibitor (Human) (C1-INH) indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in patients 6 years of age and older
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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