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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.

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 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

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

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

Atripla to Raltegravir Switch Study for CNS Toxicity
Status: Completed Condition: HIV Infection

Trial of TDF/FTC + Raltegravir Versus TDF/FTC + Efavirenz in HIV-1-Infected Women
Status: Withdrawn Condition: HIV-1 Infections

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
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;ORAL021937Jul 12, 2006RXYes5,935,946*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes6,642,245*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes5,519,021*PED<disabled><disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes5,922,695*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes8,592,397<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
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