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Generated: May 30, 2017

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Efavirenz - Generic Drug Details

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What are the generic drug sources for efavirenz and what is the scope of efavirenz freedom to operate?

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

Efavirenz has seventy-one patent family members in twenty-seven countries.

There are twenty-five drug master file entries for efavirenz. Four suppliers are listed for this compound. There are twenty-eight tentative approvals for this compound.

Summary for Generic Name: efavirenz

Drug Master File Entries: see list25
Suppliers / Packagers: see list4
Bulk Api Vendors: see list55
Clinical Trials: see list105
Patent Applications: see list5,336
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:efavirenz at DailyMed

Tentative approvals for EFAVIRENZ

Applicant Application No. Strength Dosage Form
► Subscribe► Subscribe600MG; 300MG; 300MGTABLET; ORAL
► Subscribe► Subscribe600MG; 300MG; 300MGTABLET; ORAL
► Subscribe► Subscribe200MGTABLET; ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bristol Myers Squibb
CAPSULE;ORAL020972-003Sep 17, 1998RXYesYes6,939,964*PED► SubscribeY► Subscribe
Bristol Myers Squibb
CAPSULE;ORAL020972-001Sep 17, 1998RXYesNo6,555,133*PED► SubscribeY► Subscribe
Bristol Myers Squibb
TABLET;ORAL021360-002Feb 1, 2002ABRXYesYes6,939,964*PED► SubscribeY► Subscribe
Bristol Myers Squibb
CAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo6,939,964*PED► SubscribeY► Subscribe
Bristol Myers Squibb
CAPSULE;ORAL020972-001Sep 17, 1998RXYesNo6,238,695*PED► SubscribeY► Subscribe
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