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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
Trade Name: Sovaldi
Date Designated: 10/25/2016
Orphan Designation: Treatment of pediatric chronic hepatitis C virus 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
Trade Name: Sovaldi
Marketing Approval Date: 04/07/2017
Approved Labeled Indication: Treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
Exclusivity End Date: 04/07/2024 
Exclusivity Protected Indication* :  Treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 12 years of age and older or weighing at least 35 kg without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
2 Generic Name: sofosbuvir
Trade Name: Sovaldi
Marketing Approval Date: 08/28/2019
Approved Labeled Indication: SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
Exclusivity End Date: N/A  
3 Generic Name: sofosbuvir
Trade Name: Sovaldi
Marketing Approval Date: 08/28/2019
Approved Labeled Indication: SOVALDI is indicated for the treatment of chronic HCV genotype 2 or 3 infection in pediatric patients 3 years of age and older without cirrhosis or with compensated cirrhosis for use in combination with ribavirin
Exclusivity End Date: 08/28/2026 
Exclusivity Protected Indication* :  For the treatment of chronic hepatitis C virus (HCV) genotype 2 or 3 infection in pediatric patients between 3 years of age and 12 years of age or weighing 35 kg 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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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