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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 ninety-four patent family members in thirty countries.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-three drug master file entries for this compound. Four suppliers are listed for this compound. There are five 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

Effects of Switching From ATRIPLA^TM (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028)
Status: Not yet recruiting Condition: HIV-1 Infection; CNS Toxicity

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

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

SSAT058: Atripla to Eviplera Switch in Patients Without Central Nervous System Symptoms
Status: Not yet recruiting Condition: HIV

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

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>
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Expired Patents for Tradename: ATRIPLA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,210,085*PED<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20067,402,588*PED<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,519,021*PED<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
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability<disabled in preview>
6,346,627 Intermediates in the synthesis of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
7,468,436Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
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International Patent Family for Tradename: ATRIPLA

Country Document Number Publication Date
MexicoPA05007016Sep 12, 2005
Austria419839Jan 15, 2009
China104523713Apr 22, 2015
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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.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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