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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 sixteen 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-eight tentative approvals for this compound.

Summary for Generic Name: efavirenz

Tradenames:2
Patents:16
Applicants:2
NDAs:3
Drug Master File Entries: see list22
Suppliers: see list2
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details

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

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

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

Efavirenz Comparative Bioavailability
Status: Completed Condition: Healthy

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

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

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

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;ORAL020972-002Sep 17, 1998DISCNNo6,238,695*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,639,071*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 1998RXNo6,555,133*PED<disabled>Y<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYes<disabled><disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 1998RXYes6,639,071*PED<disabled>Y<disabled>
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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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