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Details for Generic Name: efavirenz

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Efavirenz is the generic ingredient in two branded drugs marketed by Bristol Myers Squibb and Gilead, and is included in three NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for efavirenz. Two suppliers are listed for this compound. There are twenty-six tentative approvals for this compound.

Summary for Generic Name: efavirenz

Tradenames:2
Patents:17
Applicants:2
NDAs:3
Drug Master File Entries: see list22
Suppliers: see list2
Therapeutic Class:Antivirals

Tentative approvals for EFAVIRENZ

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG

Clinical Trials for: efavirenz

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

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

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

Efavirenz Comparative Bioavailability
Status: Completed Condition: Healthy

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

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

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
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998RXNo6,639,071*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998RXYes5,519,021*PED<disabled><disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972Sep 17, 1998RXYes6,238,695*PED<disabled>Y<disabled>
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, 2006RXYes5,814,639*PED<disabled>Y<disabled>
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