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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: ledipasvir/sofosbuvir
Trade Name: Harvoni
Date Designated: 10/12/2016
Orphan Designation: Treatment of chronic hepatitis C virus (HCV) infection in pediatric patients
Orphan Designation Status: Designated/Approved
Gilead Sciences, Inc.
333 Lakeside Drive
Foster City, California 94404
United States

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

Marketing approved:

1 Generic Name: ledipasvir/sofosbuvir
Trade Name: Harvoni
Marketing Approval Date: 04/07/2017
Approved Labeled Indication: Treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
Exclusivity End Date: 04/07/2024 
Exclusivity Protected Indication* :  Treatment of pediatric patients 12 years of age and older or weighing at least 35 kg with chronic hepatitis C virus genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis
2 Generic Name: ledipasvir/sofosbuvir
Trade Name: Harvoni
Marketing Approval Date: 08/28/2019
Approved Labeled Indication: HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin, and genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
Exclusivity End Date: N/A  
3 Generic Name: ledipasvir/sofosbuvir
Trade Name: Harvoni
Marketing Approval Date: 08/28/2019
Approved Labeled Indication: HARVONI is indicated for the treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin, and genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
Exclusivity End Date: 08/28/2026 
Exclusivity Protected Indication* :  For treatment of pediatric patients between 3 years of age and 12 years of age or weighing 35 kg with chronic hepatitis C virus (HCV) genotype 1, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis; (2) treatment of pediatric patients 3 years of age and older with chronic HCV genotype 1 infection with decompensated cirrhosis, for use in combination with ribavirin; and (3) treatment of pediatric patients 3 years of age and older with chronic HCV genotype 1 or 4 infection who are liver transplant recipients without cirrhosis or with compensated cirrhosis, for use in combination with ribavirin
*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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