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Details for Generic Name: efavirenz; emtricitabine; tenofovir disoproxil fumarate

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Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-five patent family members in thirty countries.

There are twenty-two drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Four suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Drug Master File Entries: see list22
Suppliers: see list4
Formulation / Manufacturing:see details


Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL600MG; 200MG; 300MG
<disabled><disabled>TABLET; ORAL600MG; 200MG; 300MG
<disabled><disabled>TABLET; ORAL300MG

Clinical Trials for: efavirenz; emtricitabine; tenofovir disoproxil fumarate

A Clinical Trial Comparing the Efficacy of Tenofovir Disoproxil Fumarate/Emtricitabine/Rilpivirine (TDF/FTC/RPV) Versus TDF/FTC/Efavirenz (TDF/FTC/EFV) in Patients With Undetectable Plasma HIV-1 RNA on Current First-line Treatment
Status: Active, not recruiting Condition: Human Immunodeficiency Virus-type 1 Infection

Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz Versus Combivir/Efavirenz in Antiretroviral-Naive HIV-1 Infected Subjects
Status: Completed Condition: HIV Infections

Efavirenz or Atazanavir/Ritonavir Given With Emtricitabine/Tenofovir Disoproxil Fumarate or Abacavir/Lamivudine in HIV Infected Treatment-Naive Adults
Status: Completed Condition: HIV Infections

Study to Evaluate Switching From a Regimen Consisting of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF) Fixed Dose Combination (FDC) to Emtricitabine/Rilpivirine/Tenofovir Alafenamide (FTC/RPV/TAF) FDC in Virologically-Suppressed, HIV-1 Infected Adults
Status: Recruiting Condition: HIV-1 Infection

Study to Evaluate the Safety and Efficacy of a Single Tablet Regimen of Emtricitabine/Rilpivirine/Tenofovir Disoproxil Fumarate Compared With a Single Tablet Regimen of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate in HIV-1 Infected, Antiretroviral Treatment-Naive Adults
Status: Completed Condition: HIV-1 Infection

Treatment of Acute HIV With Emtricitabine, Tenofovir and Efavirenz (CID 0805)
Status: Completed Condition: Acute HIV Infection; HIV Infections

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