• 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:  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
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:     
Exclusivity Protected Indication* :  
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.
 
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
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
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.
 
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
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
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-