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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/velpatasvir
Trade Name:  Epclusa
Date Designated:  02/22/2017
Orphan Designation:  Treatment of pediatric patients with chronic hepatitis C virus infection
Orphan Designation Status:  Designated/Approved
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.
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:  sofosbuvir and velpatasvir
Trade Name:  Epclusa
Date Designated:  02/22/2017
Orphan Designation:  Treatment of pediatric patients with chronic hepatitis C virus infection
Orphan Designation Status:  Designated/Approved
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
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.
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