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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: Cinryze
Date Designated: 07/16/2004
Orphan Designation: Treatment of angioedema
Orphan Designation Status: Designated/Approved
Takeda Development Center Americas, Inc.
95 Hayden Avenue
Lexington, Massachusetts 02421
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: Cinryze
Marketing Approval Date: 10/10/2008
Approved Labeled Indication: Routine prophylaxis against angioedema attacks in patients with Hereditary Angioedema (HAE)
Exclusivity End Date: 10/10/2015 
Exclusivity Protected Indication* :  
2 Generic Name: C1 esterase inhibitor (human)
Trade Name: Cinryze
Marketing Approval Date: 06/20/2018
Approved Labeled Indication: CINRYZE is a C1 esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adults, adolescents and pediatric patients (6 years old and above) with Hereditary Angioedema (HAE).
Exclusivity End Date: 06/20/2025 
Exclusivity Protected Indication* :  CINRYZE (C1 esterase inhibitor [human]) is indicated for routine prophylaxis against angioedema attacks in pediatric patients ages 6-11 with Hereditary Angioedema (HAE).
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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