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Emtricitabine

Generic Name
Emtricitabine
Brand Names
Atripla, Biktarvy, Complera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, Truvada, Emtricitabine/Tenofovir disoproxil Zentiva, Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan
Drug Type
Small Molecule
Chemical Formula
C8H10FN3O3S
CAS Number
143491-57-0
Unique Ingredient Identifier
G70B4ETF4S

Overview

Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) indicated for the treatment of HIV infection in adults or combined with tenofovir alafenamide for the prevention of HIV-1 infection in high risk adolescents and adults. Emtricitabine is a cytidine analogue. The drug works by inhibiting HIV reverse transcriptase, preventing transcription of HIV RNA to DNA. Emtricitabine was granted FDA approval on 2 July 2003.

Background

Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) indicated for the treatment of HIV infection in adults or combined with tenofovir alafenamide for the prevention of HIV-1 infection in high risk adolescents and adults. Emtricitabine is a cytidine analogue. The drug works by inhibiting HIV reverse transcriptase, preventing transcription of HIV RNA to DNA. Emtricitabine was granted FDA approval on 2 July 2003.

Indication

Emtricitabine is indicated in combination with other medications for the treatment of HIV-1 infections; treatment of HIV-1 infections in pediatric patients 25-35kg, treatment of HIV-1 infections in adult patients ≥35kg, for pre exposure prophylaxis of HIV-1 in adolescent and adult patients excluding those who have receptive vaginal sex; treatment of HIV-1 infections in pediatric and adult patients ≥17kg, pre exposure prophylaxis in adolescents and adults ≥35kg; treatment of HIV-1 in patients ≥12 years and ≥35kg; treatment of HIV-1 in patients weighing ≥35kg; treatment of HIV-1 in patients weighing ≥25kg; and treatment of HIV-1 in patients weighing ≥40kg.

Associated Conditions

  • HIV Transmission
  • Human Immunodeficiency Virus (HIV) Infections
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

FDA Approved Products

Emtricitabine and Tenofovir Disoproxil Fumarate
Manufacturer:QUALLENT PHARMACEUTICALS HEALTH LLC
Route:ORAL
Strength:200 mg in 1 1
Approved: 2023/09/08
NDC:82009-109
Truvada
Manufacturer:Gilead Sciences, Inc
Route:ORAL
Strength:167 mg in 1 1
Approved: 2023/10/20
NDC:61958-0705
Emtricitabine and Tenofovir Disoproxil Fumarate
Manufacturer:Strides Pharma Science Limited
Route:ORAL
Strength:200 mg in 1 1
Approved: 2024/03/06
NDC:64380-719
DESCOVY
Manufacturer:Gilead Sciences, Inc.
Route:ORAL
Strength:120 mg in 1 1
Approved: 2022/01/20
NDC:61958-2005
Truvada
Manufacturer:State of Florida DOH Central Pharmacy
Route:ORAL
Strength:200 mg in 1 1
Approved: 2010/04/13
NDC:53808-0805

Singapore Approved Products

ODEFSEY FILM-COATED TABLET 200MG/25MG/25MG
Manufacturer:Patheon Inc., Rottendorf Pharma GmbH, Rottendorf Pharma GmbH (Primary packager)
Form:TABLET, FILM COATED
Strength:200mg
Online:Yes
Approved: 2020/09/25
Approval:SIN16015P
DESCOVY FILM COATED TABLET 200 MG/25 MG
Manufacturer:Patheon Inc., Gilead Sciences Ireland UC (Primary and secondary packager), Rottendorf Pharma GmbH (Ostenfelder), Rottendorf Pharma GmbH (Am Fleigendahl) (Primary packager)
Form:TABLET, FILM COATED
Strength:200.0mg
Online:Yes
Approved: 2017/08/21
Approval:SIN15322P
COMPLERA FILM-COATED TABLET 200MG/25MG/300MG
Manufacturer:Patheon, Inc., Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:200 mg
Online:Yes
Approved: 2016/02/29
Approval:SIN14965P
Truvada Tablet 200mg/300mg
Manufacturer:Takeda GmbH, Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:200mg
Online:Yes
Approved: 2012/05/14
Approval:SIN14147P
BIKTARVY FILM-COATED TABLETS 50MG/200MG/25MG
Manufacturer:Rottendorf Pharma GmbH, Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:200mg
Online:Yes
Approved: 2019/01/02
Approval:SIN15604P

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