• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals

  • Print
  • Share
  • E-mail
-
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: TBD  

*Exclusivity Protected Indications are shown for approvals from Jan. 1, 2013, to the present.
-
-