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Efavirenz - Generic Drug Details

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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 sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has sixty-eight patent family members in twenty-seven countries.

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

Summary for Generic Name: efavirenz

Tradenames:3
Patents:16
Applicants:3
NDAs:4
Drug Master File Entries: see list24
Suppliers / Packagers: see list4
Bulk Api Vendors: see list55
Clinical Trials: see list105
Patent Applications: see list5,639
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
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL200MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes5,977,089*PED► subscribeY► subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 2002RXYesYes► subscribe► subscribe
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYesYes5,922,695*PED► subscribeY► subscribe
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Expired Orange Book Patents for Generic Ingredient: efavirenz

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,663,169*PED► subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-001Sep 17, 19985,811,423► subscribe
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 19985,663,169*PED► subscribe
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Non-Orange Book Patents for Generic Ingredient: efavirenz

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
5,965,729 Process for the crystallization of a reverse transcriptase inhibitor using an anti-solvent► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: efavirenz

Country Document Number Estimated Expiration
Poland194309► subscribe
Brazil9908810► subscribe
Hungary229087► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: EFAVIRENZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
01C/001Belgium► subscribePRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
C/GB08/022United Kingdom► subscribePRODUCT NAME: A COMBINATION OF EFAVIRENZ, EMTRICITABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT OR ESTER THEREOF, AND TENOFOVIR OR A PHARMACEUTICALLY ACCEPTABLE PRODRUG, SALT OR ESTER THEREOF, PARTICULARLY TENOFOVIR DISOPROXIL, ESPECIALLY TENOFOVIR DISOPROXIL FUMARATE; REGISTERED: UK EU/1/07/430/001 20071213
C0020France► subscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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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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