Regulatory PathRegulatory requirements compared

Active substances

Emtricitabine + Tenofovir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DANOVAR300,200 mg,mgFilm-coated tablet · Oral use30 BottleSAR 1464.00Generic · PrescriptionTabuk Pharmaceutical Manufacturing CompanyValid
DESCOVY 200MG/10MG F.C.TABLET200,11.2 mg,mgFilm-coated tablet · Oral use30 BottleSAR 1626.35NCE · PrescriptionGilead Sciences International LtdValid
DESCOVY 200MG/25MG F.C.TABLET200,28 mg,mgFilm-coated tablet · Oral use30 BottleSAR 1626.35NCE · PrescriptionGilead Sciences International LtdValid
Divira300,200 mg,mgTablet · Oral use30 Tablet ContainerSAR 1366.40Generic · PrescriptionSaudi AmaroxValid
Indications — CHI Daman Drug Formulary

HUMAN IMMUNODEFICIENCY VIRUS

US FDA United States — FDA approvals (Drugs@FDA)

ProductStrengthForm · routeApplicantStatusFirst approved
TRUVADA200MG;300MG; 100MG;150MG; 133MG;200MG; 167MG;250MGtablet · oralGILEADPrescription2 Aug 2004
DESCOVY200MG;EQ 25MG BASE; 120MG;EQ 15MG BASEtablet · oralGILEAD SCIENCES INCPrescription4 Apr 2016
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralTEVA PHARMS USAPrescription8 Jun 2017
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralAUROBINDO PHARMAPrescription26 Jan 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MG; 133MG;200MG; 167MG;250MG; 200MG;300MGtablet · oralAMNEAL PHARMS COPrescription22 Aug 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralLAURUSPrescription26 Jul 2019
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MG; 100MG;150MG; 133MG;200MG; 167MG;250MGtablet · oralZYDUS PHARMSPrescription28 Feb 2020
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralMACLEODS PHARMSPrescription15 May 2020
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralSTRIDES PHARMAPrescription13 Jan 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralCHARTWELL RXPrescription4 Jun 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MG; 100MG;150MG; 133MG;200MG; 167MG;250MGtablet · oralHETERO LABS LTD IIIPrescription7 Oct 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE100MG;150MG; 133MG;200MG; 167MG;250MGtablet · oralAUROBINDO PHARMA LTDPrescription9 Mar 2023
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASEtablet · oralMACLEODS PHARMSPrescription7 Apr 2026
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASEtablet · oralNATCOPrescription26 Aug 2026
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralPHARMOBEDIENTDiscontinued9 Apr 2018
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralCIPLADiscontinued2 Apr 2021
EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE200MG;300MGtablet · oralAPOTEXDiscontinued16 Jun 2021
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE120MG;EQ 15MG BASE; 200MG;EQ 25MG BASEtablet · oralAPOTEXDiscontinued17 May 2024
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE200MG;EQ 25MG BASEtablet · oralLUPINDiscontinued13 Dec 2024

EMA European Union — centrally authorised medicines

Truvada Gilead Sciences Ireland UC · Authorised · authorised 20 Feb 2005 · ATC J05AR03

Therapeutic indication (EMA)

Treatment of HIV-1 infection: Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Truvada is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years. Pre-exposure prophylaxis (PrEP): Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Descovy Gilead Sciences Ireland UC · Authorised · authorised 21 Apr 2016 · ATC J05AR17

Therapeutic indication (EMA)

Descovy is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).

Emtricitabine/Tenofovir disoproxil Zentiva Zentiva k.s. · Authorised · authorised 9 Nov 2016 · ATC J05AR03

Therapeutic indication (EMA)

Treatment of HIV-1 infection Emtricitabine/Tenofovir disoproxil Zentiva is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Zentiva is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents. Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Zentiva is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk.

Emtricitabine/Tenofovir disoproxil Krka KRKA, d.d., Novo mesto · Authorised · authorised 9 Dec 2016 · ATC J05AR03

Therapeutic indication (EMA)

Treatment of HIV-1 infection Emtricitabine/tenofovir disoproxil Krka is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years (see section 5.1 Pre-exposure prophylaxis (PrEP) Emtricitabine/Tenofovir disoproxil Krka is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.

Emtricitabine/Tenofovir disoproxil Mylan Mylan Pharmaceuticals Limited · Authorised · authorised 16 Dec 2016 · ATC J05AR03

Therapeutic indication (EMA)

Treatment of HIV-1 infection: Emtricitabine/Tenofovir disoproxil Mylan is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults (see section 5.1). Emtricitabine/Tenofovir disoproxil Mylan is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, (see sections 4.2, 4.4 and 5.1). Pre-exposure prophylaxis (PrEP): Emtricitabine/Tenofovir disoproxil Mylan is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents at high risk (see sections 4.2, 4.4 and 5.1).

Emtricitabine/Tenofovir disoproxil Krka d.d. KRKA, d.d., Novo mesto · Authorised · authorised 28 Apr 2017 · ATC J05AR03

Therapeutic indication (EMA)

Emtricitabine/Tenofovir disoproxil Krka d.d. is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults. Emtricitabine/Tenofovir disoproxil Krka d.d. is also indicated for the treatment of HIV-1 infected adolescents, with NRTI resistance or toxicities precluding the use of first line agents, aged 12 to < 18 years.

Emtricitabine / Tenofovir alafenamide Viatris Viatris Limited · Authorised · authorised 18 Jul 2025 · ATC J05AR17

Therapeutic indication (EMA)

Emtricitabine/Tenofovir alafenamide Viatris is indicated in combination with other antiretroviral agents for the treatment of adults and adolescents (aged 12 years and older with body weight at least 35 kg) infected with human immunodeficiency virus type 1 (HIV-1).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-EMTRICITABINE / TENOFOVIR DISOPROXIL FUMARATE02496356200 MG; 300 MGTABLET · ORALANGITA PHARMA INC.
APO-EMTRICITABINE-TENOFOVIR02452006300 MG; 200 MGTABLET · ORALAPOTEX INC
AURO-EMTRICITABINE-TENOFOVIR02490684300 MG; 200 MGTABLET · ORALAURO PHARMA INC
DESCOVY02454416200 MG; 10 MGTABLET · ORALGILEAD SCIENCES CANADA INC
DESCOVY0245442425 MG; 200 MGTABLET · ORALGILEAD SCIENCES CANADA INC
JAMP EMTRICITABINE/TENOFOVIR DISOPROXIL FUMARATE02487012200 MG; 300 MGTABLET · ORALJAMP PHARMA CORPORATION
MINT-EMTRICITABINE/TENOFOVIR02521547300 MG; 200 MGTABLET · ORALMINT PHARMACEUTICALS INC
MYLAN-EMTRICITABINE/TENOFOVIR DISOPROXIL02443902200 MG; 300 MGTABLET · ORALMYLAN PHARMACEUTICALS ULC
PMS-EMTRICITABINE-TENOFOVIR02461110200 MG; 300 MGTABLET · ORALPHARMASCIENCE INC
TEVA-EMTRICITABINE/TENOFOVIR02399059200 MG; 300 MGTABLET · ORALTEVA CANADA LIMITED
TRUVADA02274906200 MG; 300 MGTABLET · ORALGILEAD SCIENCES CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDESCOVY 120-15 MG TABLET$74.85402per EA29 Jun 2026
US NADACDESCOVY 200-25 MG TABLET$74.94147per EA29 Jun 2026
US NADACEMTRICITABINE-TENOFOVIR DISOPROXIL FUMARATE 100-150 MG TAB$10.19448per EA22 Apr 2026
US NADACEMTRICITABINE-TENOFOVIR DISOPROXIL FUMARATE 200-300 MG TAB$0.52902per EA23 Sep 2026
US NADACTRUVADA 200 MG-300 MG TABLET$59.70975per EA23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

WHO WHO Model List of Essential Medicines (2025)

  • 6.4.2.5. Fixed-dose combinations of antiretrovirals · core
    Contact with or exposure to human immunodeficiency virus; Human immunodeficiency virus disease without mention of tuberculosis or malaria, clinical stage unspecified
    Oral > Solid: 200 mg + 300 mg (tenofovir disoproxil fumarate equivalent to 245 mg tenofovir disoproxil)

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.