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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

Drug Master File Entries: see list22
Suppliers / Packaging: see list4
Therapeutic Class:Antivirals

Tentative approvals for EFAVIRENZ

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL200MG

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
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
TABLET;ORAL021360-002Feb 1, 2002RXYes<disabled><disabled>
Bristol Myers Squibb
CAPSULE;ORAL020972-001Sep 17, 1998RXNo<disabled><disabled>
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,703,396*PED<disabled>Y<disabled>
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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.

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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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