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Tenofovir disoproxil

Generic Name
Tenofovir disoproxil
Brand Names
Atripla, Cimduo, Complera, Delstrigo, Stribild, Symfi, Truvada, Viread, Tenofovir disoproxil Mylan
Drug Type
Small Molecule
Chemical Formula
C19H30N5O10P
CAS Number
201341-05-1
Unique Ingredient Identifier
F4YU4LON7I

Overview

Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 .

Background

Tenofovir disoproxil fumarate (a prodrug of tenofovir), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (nRTIs). This drug is prescribed in combination with other drugs for the management of HIV infection as well as for Hepatitis B therapy. Tenofovir disoproxil was initially approved in 2001 .

Indication

Tenofovir disoproxil is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in patients ≥2 years old and weighing ≥10 kg. It is also indicated for the treatment of chronic hepatitis B in patients ≥2 years old and weighing ≥10 kg. Tenofovir disoproxil is also an ingredient in several combination products, all of which are indicated either alone or in combination with other antiretrovirals for the treatment of HIV-1 infection. In addition, tenofovir disoproxil is available in combination with emtricitabine (under the brand name Truvada) for use as pre-exposure prophylaxis (PrEP) in at-risk adults and adolescents weighing ≥ 35kg to reduce the risk of sexually-acquired HIV-1 infection.

Associated Conditions

  • Chronic Hepatitis B Infection
  • Human Immunodeficiency Virus Type 1 (HIV-1) Infection

FDA Approved Products

Emtricitabine and Tenofovir Disoproxil Fumarate
Manufacturer:QUALLENT PHARMACEUTICALS HEALTH LLC
Route:ORAL
Strength:300 mg in 1 1
Approved: 2023/09/08
NDC:82009-109
Efavirenz, Lamivudine and Tenofovir Disoproxil Fumarate
Manufacturer:Laurus Labs Limited
Route:ORAL
Strength:300 mg in 1 1
Approved: 2019/01/16
NDC:42385-929
Truvada
Manufacturer:Gilead Sciences, Inc
Route:ORAL
Strength:250 mg in 1 1
Approved: 2023/10/20
NDC:61958-0705
Emtricitabine and Tenofovir Disoproxil Fumarate
Manufacturer:Strides Pharma Science Limited
Route:ORAL
Strength:300 mg in 1 1
Approved: 2024/03/06
NDC:64380-719
Truvada
Manufacturer:RedPharm Drug, Inc.
Route:ORAL
Strength:300 mg in 1 1
Approved: 2022/01/20
NDC:67296-1237

Singapore Approved Products

TENOF TENOFOVIR DISOPROXIL FUMARATE FILM-COATED TABLETS 300 MG
Manufacturer:Hetero Labs Limited
Form:TABLET, FILM COATED
Strength:300mg
Online:Yes
Approved: 2018/10/19
Approval:SIN15564P
COMPLERA FILM-COATED TABLET 200MG/25MG/300MG
Manufacturer:Patheon, Inc., Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:300 mg
Online:Yes
Approved: 2016/02/29
Approval:SIN14965P
VIRCLEAN F.C. TABLETS 300MG
Manufacturer:2nd Plant, Standard Chem. & Pharm. Co. Ltd.
Form:TABLET, FILM COATED
Strength:300 mg
Online:Yes
Approved: 2021/01/06
Approval:SIN16078P
Truvada Tablet 200mg/300mg
Manufacturer:Takeda GmbH, Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:300mg
Online:Yes
Approved: 2012/05/14
Approval:SIN14147P
Viread Tablets 300mg
Manufacturer:Takeda GmbH, Gilead Sciences Ireland UC
Form:TABLET, FILM COATED
Strength:300 mg
Online:Yes
Approved: 2011/03/28
Approval:SIN13938P

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