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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: setmelanotide
Trade Name: Imcivree
Date Designated: 09/19/2019
Orphan Designation: Treatment of Bardet-Biedl syndrome
Orphan Designation Status: Designated/Approved
Rhythm Pharmaceuticals, Inc.
222 Berkeley Street
Suite 1200
Boston, Massachusetts 02116
United States

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

Marketing approved:

1 Generic Name: setmelanotide
Trade Name: Imcivree
Marketing Approval Date: 06/16/2022
Approved Labeled Indication: For chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS)
Exclusivity End Date: 06/16/2029 
Exclusivity Protected Indication* :  For chronic weight management in adult and pediatric patients 6 years of age and older with monogenic or syndromic obesity due to Bardet-Biedl syndrome (BBS)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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