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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 ninety 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

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, 2006RXYes6,939,964*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,977,089*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, 2006RXYes6,639,071*PED<disabled>Y<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
5,892,025 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent<disabled in preview>
8,871,271Method and composition for pharmaceutical product<disabled in preview>
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds<disabled in preview>
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
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International Patent Family for Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country Document Number Publication Date
Portugal2386294Jun 16, 2015
New Zealand564102Jun 29, 2012
Cyprus1108973Jul 02, 2014
World Intellectual Property Organization (WIPO)2006135933May 24, 2007
European Patent Office1923063May 21, 2008
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

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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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