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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: maralixibat
Trade Name: Livmarli
Date Designated: 09/04/2013
Orphan Designation: Treatment of progressive familial intrahepatic cholestasis
Orphan Designation Status: Designated/Approved
Mirum Pharmaceuticals, Inc.
989 E Hillsdale Blvd., Suite 300
Foster City, California 94404
United States

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

Marketing approved:

1 Generic Name: maralixibat
Trade Name: Livmarli
Marketing Approval Date: 03/13/2024
Approved Labeled Indication: treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC)
Exclusivity End Date: 03/13/2031 
Exclusivity Protected Indication* :  treatment of cholestatic pruritus in patients 5 years of age and older with progressive familial intrahepatic cholestasis (PFIC)
2 Generic Name: maralixibat
Trade Name: Livmarli
Marketing Approval Date: 07/24/2024
Approved Labeled Indication: treatment of cholestatic pruritus in patients 12 months of age and older with progressive familial intrahepatic cholestasis (PFIC)
Exclusivity End Date: 07/24/2031 
Exclusivity Protected Indication* :  treatment of cholestatic pruritus in patients 12 months of age to less than 5 years of age with progressive familial intrahepatic cholestasis (PFIC)
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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