Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
  • Print
  • Share
  • E-mail
-
Generic Name: alirocumab
Trade Name: Praluent
Date Designated: 06/15/2017
Orphan Designation: Treatment of homozygous familial hypercholesterolemia
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: alirocumab
Trade Name: Praluent
Marketing Approval Date: 04/01/2021
Approved Labeled Indication: as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C
Exclusivity End Date: 04/01/2028 
Exclusivity Protected Indication* :  as an adjunct to other LDL-C-lowering therapies in adult patients with homozygous familial hypercholesterolemia (HoFH) to reduce LDL-C
2 Generic Name: alirocumab
Trade Name: Praluent
Marketing Approval Date: 10/09/2025
Approved Labeled Indication: as an adjunct to diet and exercise to reduce low- density lipoprotein cholesterol (LDL-C) in adults with homozygous familial hypercholesterolemia (HoFH)
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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
-
-