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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 fifteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has eigthy-seven 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

Tradenames:1
Patents:15
Applicants:1
NDAs:1
Drug Master File Entries: see list22
Suppliers / Packaging: see list4
Formulation / Manufacturing:see details

Tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

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

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,935,946*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes8,598,185<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,922,695*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes9,018,192<disabled><disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes8,592,397<disabled>Y<disabled>
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Non-Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
5,519,021 Benzoxazinones as inhibitors of HIV reverse transcriptase<disabled in preview>
5,210,085 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds<disabled in preview>
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds<disabled in preview>
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International Patent Family for Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country Document Number Publication Date
World Intellectual Property Organization (WIPO)2006135932May 24, 2007
China1738628Jun 06, 2012
CroatiaP20140379Jul 18, 2014
Australia2004206821Aug 05, 2004
South Korea20080032014Apr 11, 2008
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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