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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
*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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