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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
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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