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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: emtricitabine and tenofovir alafenamide
Trade Name: Descovy
Date Designated: 06/06/2017
Orphan Designation: Treatment of HIV-1 infection in pediatric patients under 12 years of age
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: emtricitabine and tenofovir alafenamide
Trade Name: Descovy
Marketing Approval Date: 09/28/2017
Approved Labeled Indication: DESCOVY, indicated in combination with other antiretroviral agents, for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35 kg and also indicated, in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients weighing at least 25 kg and less than 35 kg.
Exclusivity End Date: 09/28/2024 
Exclusivity Protected Indication* :  ¿ In combination with other antiretroviral agents, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 35kg; and ¿ In combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor, for the treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 25kg and less than 35kg
2 Generic Name: emtricitabine and tenofovir alafenamide
Trade Name: Descovy
Marketing Approval Date: 01/07/2022
Approved Labeled Indication: Treatment of HIV-1 infection in pediatric patients weighing at least 14 kg and less than 35 kg in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor
Exclusivity End Date: 01/07/2029 
Exclusivity Protected Indication* :  Treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 14 kg to less than 25 kg in combination with other antiretroviral agents other than protease inhibitors that require a CYP3A inhibitor
3 Generic Name: emtricitabine and tenofovir alafenamide
Trade Name: Descovy
Marketing Approval Date: 06/20/2025
Approved Labeled Indication: treatment of HIV-1 infection in pediatric patients weighing at least 14 kg to less than 35 kg in combination with other antiretroviral agents, including darunavir and cobicistat but not other protease inhibitors that require a CYP3A inhibitor
Exclusivity End Date: 06/20/2032 
Exclusivity Protected Indication* :  treatment of HIV-1 infection in pediatric patients under 12 years of age weighing at least 14 kg to less than 35 kg in combination with darunavir and cobicistat
*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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