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U.S. Department of Health and Human Services

Search Orphan Drug Designations and Approvals
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Generic Name: cobicistat
Trade Name: Tybost®
Date Designated: 06/15/2017
Orphan Designation: Treatment of human immunodeficiency virus type 1 (HIV-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: cobicistat
Trade Name: Tybost®
Marketing Approval Date: 08/22/2019
Approved Labeled Indication: TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients weighing at least 35 kg
Exclusivity End Date: 08/22/2026 
Exclusivity Protected Indication* :  Indicated to increase systemic exposure of atazanavir in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients weighing at least 35 kg.
2 Generic Name: cobicistat
Trade Name: Tybost®
Marketing Approval Date: 10/03/2019
Approved Labeled Indication: TYBOST is a CYP3A inhibitor indicated to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients weighing at least 35 kg coadminstered with atazanavir or weighing at least 40 kg coadministered with darunavir.
Exclusivity End Date: N/A  
3 Generic Name: cobicistat
Trade Name: Tybost
Marketing Approval Date: 06/20/2025
Approved Labeled Indication: to increase systemic exposure of atazanavir or darunavir (once daily dosing regimen) in combination with other antiretroviral agents in the treatment of HIV-1 infection in pediatric patients weighing at least 14 kg
Exclusivity End Date: TBD  
*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*Data for the Date Designation Withdrawn or Revoked field are shown for designations withdrawn or revoked after 08/12/2013.
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