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Profile for Tradename: Atripla

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Atripla is a drug marketed by Gilead and is included in one NDA. It is available from four suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-two drug master file entries for this compound. Four suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

Clinical Trials for: Atripla

Glossary
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, 2006RXYes6,043,230*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,642,245*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes8,716,264<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,663,169*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes8,598,185<disabled>Y<disabled>
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Paragraph IV activity for: ATRIPLA

Drugname Dosage Strength RLD Submissiondate
efavirenz, emtricitabine and tenofovir disoproxil fumarateTablets600 mg/200 mg/300 mgAtripla12/29/2008

Non-Orange Book Patents for Tradename: ATRIPLA

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
5,811,423 Benzoxazinones as inhibitors of HIV reverse transcriptase<disabled in preview>
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
6,931,679 Foldable stand for a hammock<disabled in preview>
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues<disabled in preview>
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International Patent Family for Tradename: ATRIPLA

Country Document Number Publication Date
Taiwan200425895Dec 01, 2004
New Zealand540728Aug 29, 2008
CroatiaP20050619Oct 31, 2005
Hong Kong1079122Aug 29, 2008
BrazilPI0406760Dec 20, 2005
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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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