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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: sofosbuvir and velpatasvir
Trade Name: Epclusa
Date Designated: 02/22/2017
Orphan Designation: Treatment of pediatric chronic hepatitis C virus (HCV) infection
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: sofosbuvir and velpatasvir
Trade Name: Epclusa
Marketing Approval Date: 03/19/2020
Approved Labeled Indication: EPCLUSA is indicated for the treatment of adults and pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin.
Exclusivity End Date: 03/19/2027 
Exclusivity Protected Indication* :  For the treatment of pediatric patients 6 years of age and older or weighing at least 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated cirrhosis for use in combination with ribavirin.
2 Generic Name: sofosbuvir and velpatasvir
Trade Name: Epclusa
Marketing Approval Date: 06/10/2021
Approved Labeled Indication: treatment of adults and pediatric patients 3 years of age and older with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis, or with decompensated cirrhosis for use in combination with ribavirin
Exclusivity End Date: 06/10/2028 
Exclusivity Protected Indication* :  treatment of pediatric patients 3 years of age to less than 6 years of age weighing less than 17 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection: without cirrhosis or with compensated cirrhosis; or with decompensated 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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