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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 fifteen patents protecting this drug and one Paragraph IV challenge.

This drug has eigthy-seven 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

A Trial Comparing GSK1349572 50mg Plus Abacavir/Lamivudine Once Daily to Atripla (Also Called The SINGLE Trial)
Status: Active, not recruiting Condition: Infection, Human Immunodeficiency Virus I

Sleep and Cognition After Atripla to Stribild Switch
Status: Recruiting Condition: HIV

Comparison of MK-1439A and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus (HIV)-Infected Participants (MK-1439A-021)
Status: Recruiting Condition: Human Immunodeficiency Virus (HIV)

Effect of SwitChing AtriPla to Eviplera on Neurocognitive and Emotional Functioning
Status: Not yet recruiting Condition: Neurocognitive Decline; HIV Associated Neurocognitive Disorder

Study of the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Status: Completed Condition: HIV; HIV Infections

Atripla to Stribild Switch Study to Evaluate Sleep Disturbances
Status: Active, not recruiting Condition: HIV; AIDS; Sleep Disorders

The Bioequivalence of Atripla in an Oral Liquid Formulation Compared With the Tablet Formulation in Healthy Volunteers
Status: Completed Condition: Healthy

Interaction Study to Assess the Pharmacokinetic Interaction of Oral Administration of Rifapentine on ATRIPLA™ in HIV Patients
Status: Completed Condition: Tuberculosis

ONCE - Only Nocturnal Combination Evaluation of Antiretroviral-Experienced HIV 1 Infected Subjects Switching to Atripla
Status: Completed Condition: HIV Infections

Study to Evaluate the Safety and Efficacy of Stribild Versus Atripla in Human Immunodeficiency Virus, Type 1 (HIV-1) Infected, Antiretroviral Treatment-Naive Adults
Status: Completed Condition: HIV; 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, 2006RXYes8,592,397<disabled>Y<disabled>
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, 2006RXYes9,018,192<disabled><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, 2006RXYes6,703,396*PED<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
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 Tradename: ATRIPLA

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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Preferred citation:

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

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