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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 Labs Ltd, 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-three 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

Tradenames:3
Patents:16
Applicants:3
NDAs:4
Drug Master File Entries: see list23
Suppliers / Packaging: see list4
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; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL200MG

Clinical Trials for: efavirenz

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;ORAL020972-001Sep 17, 1998RXNo<disabled><disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-002Sep 17, 1998DISCNNo6,939,964*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,703,396*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: efavirenz

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-002Feb 1, 20025,519,021*PED<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
TABLET;ORAL021360-001Feb 1, 20025,633,169<disabled>
Bristol Myers Squibb
SUSTIVA
efavirenz
CAPSULE;ORAL020972-003Sep 17, 19985,811,423<disabled>
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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<disabled in preview>
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International Patent Family for Ingredient: efavirenz

Country Document Number Estimated Expiration
Poland197740<disabled in preview>
Australia738545<disabled in preview>
Eurasian Patent Organization001805<disabled in preview>
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Supplementary Protection Certificates for Tradename: EFAVIRENZ

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02Switzerland<disabled>PRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
08/016Ireland<disabled>PRODUCT NAME: A COMBINATION OF EFAVIRENZ AND EMTRICTABINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
C0020France<disabled>PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
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