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Generated: April 29, 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 freedom to operate?

Efavirenz
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 sixty-eight patent family members in twenty-seven countries.

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

Summary for Generic Name: efavirenz

Tradenames:3
Patents:18
Applicants:3
NDAs:4
Drug Master File Entries: see list25
Suppliers / Packagers: see list3
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. Form Dosage
► Subscribe► SubscribeTABLET; ORAL600MG; 300MG; 300MG
► Subscribe► SubscribeTABLET; ORAL600MG; 300MG; 300MG
► Subscribe► SubscribeTABLET; ORAL200MG
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
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002ABRXYesYes6,639,071*PED► SubscribeY► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002ABRXYesYes► Subscribe► Subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998DISCNYesNo6,939,964*PED► SubscribeY► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes8,598,185► SubscribeY ► Subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes6,642,245*PED► SubscribeY► Subscribe
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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. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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