Search Orphan Drug Designations and Approvals
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Generic Name: | sofosbuvir | ||||||||||||||||
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Trade Name: | Sovaldi | ||||||||||||||||
Date Designated: | 10/25/2016 | ||||||||||||||||
Orphan Designation: | Treatment of pediatric chronic hepatitis C virus infection | ||||||||||||||||
Orphan Designation Status: | Designated/Approved | ||||||||||||||||
Sponsor: |
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. |
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Marketing approved: |
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1 | Generic Name: | sofosbuvir |
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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 |
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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 |
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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. | |
*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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