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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, 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
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: bictegravir, emtricitabine, and tenofovir alafenamide
Trade Name: Biktarvy
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
2 Generic Name: bictegravir, emtricitabine, and tenofovir alafenamide
Trade Name: Biktarvy
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: 10/07/2028 
Exclusivity Protected Indication* :  As a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing 14 kg to less than 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 regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Biktarvy
3 Generic Name: bictegravir, emtricitabine, and tenofovir alafenamide
Trade Name: Biktarvy
Marketing Approval Date: 02/23/2024
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: (1) who have no antiretroviral treatment history or (2) 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 known or suspected substitutions associated with resistance to bictegravir or tenofovir
Exclusivity End Date: 02/23/2031 
Exclusivity Protected Indication* :  treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg 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 known or suspected substitutions associated with resistance to bictegravir or tenofovir and with known or suspected substitutions associated with resistance to emtricitabine
4 Generic Name: bictegravir, emtricitabine, and tenofovir alafenamide
Trade Name: Biktarvy
Marketing Approval Date: 07/30/2025
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 with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir
Exclusivity End Date: 07/30/2032 
Exclusivity Protected Indication* :  treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg with an antiretroviral treatment history and not virologically suppressed, with no known or suspected substitutions associated with resistance to the integrase strand inhibitor class, emtricitabine, or tenofovir
*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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