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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

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Generic Name:  bictegravir/emtricitabine/tenofovir alafenamide
Trade Name:  BIKTARVY
Date Designated:  05/17/2017
Orphan Designation:  Treatment of Human Immunodeficiency Virus type 1 infection in pediatric patients
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  06/18/2019 
Approved Labeled Indication:  BIKTARVY® is indicated as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral with no history of treatment failure and no known substitutions associated with resistance to the individual components o
Exclusivity End Date:    06/18/2026 
Exclusivity Protected Indication* :  As a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 25 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral with no history of treatment failure and no known substitutions associated with resistance to the individual components of
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:  bictegravir, emtricitabine, and tenofovir alafenamide
Trade Name:  Biktarvy
Date Designated:  05/17/2017
Orphan Designation:  Treatment of Human Immunodeficiency Virus type 1 infection in pediatric patients
Orphan Designation Status:  Designated/Approved
Marketing Approval Date:  10/07/2021 
Approved Labeled Indication:  As a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy
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.
*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
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