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Profile for Tradename: SUSTIVA

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Sustiva is a drug marketed by Bristol Myers Squibb and is included in two NDAs. It is available from two suppliers. There are five patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in SUSTIVA is efavirenz. There are twenty-three drug master file entries for this compound. Two suppliers are listed for this compound. There are twenty-six tentative approvals for this compound. Additional details are available on the efavirenz profile page.

Clinical Trials for: SUSTIVA

Sustiva Levels With Use of a Gel Capsule
Status: Completed Condition: HIV; HIV Infections

Modification of Doses of Efavirenz According to Its Blood Concentration in HIV Patients
Status: Completed Condition: HIV

Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Pharmacodynamics; Intestinal Transporter Expression

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Status: Active, not recruiting Condition: Hyperlipidemia; HIV

Pharmacokinetic Interaction Study of Efavirenz and American Ginseng in Healthy Volunteers
Status: Active, not recruiting Condition: Healthy Volunteers

Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics
Status: Completed Condition: HIV

Efavirenz Comparative Bioavailability
Status: Completed Condition: Healthy

Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Status: Completed Condition: Healthy

PK of Efavirenz & Lopinavir Nano-formulations in Healthy Volunteers
Status: Recruiting Condition: HIV

GSK1349572 Drug Interaction Study With Efavirenz
Status: Completed Condition: Infections, Human Immunodeficiency Virus and Herpesviridae; 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
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXNo6,939,964*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYes<disabled><disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002RXYes6,639,071*PED<disabled>Y<disabled>
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Expired Patents for Tradename: SUSTIVA

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,633,169<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,663,169*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 19985,663,169*PED<disabled>
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Paragraph IV activity for: SUSTIVA

Drugname Dosage Strength RLD Submissiondate
efavirenzTablets600 mgSustiva4/9/2009
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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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