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Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in one branded drug marketed by Gilead and is included in one NDA. There are fourteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and eighty-one patent family members in forty-seven countries.

There are twenty-three drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Five suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for Generic Name: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Tradenames:1
Patents:14
Applicants:1
NDAs:1
Drug Master File Entries: see list23
Suppliers / Packaging: see list5
Formulation / Manufacturing:see details

Tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL600MG; 200MG; 300MG
<disabled><disabled>TABLET; ORAL600MG; 200MG; 300MG
<disabled><disabled>TABLET; ORAL600MG

Clinical Trials for: efavirenz; emtricitabine; tenofovir disoproxil fumarate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes5,914,331*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,939,964*PED<disabled>Y<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 2006RXYes6,043,230*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,210,085*PED<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,814,639*PED<disabled>
Gilead
ATRIPLA
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937-001Jul 12, 20065,811,423<disabled>
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Non-Orange Book Patents for Generic Ingredient: efavirenz; emtricitabine; tenofovir disoproxil fumarate

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
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability<disabled in preview>
7,402,588Antiviral activity and resolution of 2-hydroxymethyl-5-(5-fluorocytosin-1-yl)-1,3-oxathiolane<disabled in preview>
6,069,252 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
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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; emtricitabine; tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Denmark1890681<disabled in preview>
China1127301<disabled in preview>
Portugal1243590<disabled in preview>
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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; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C021/2005Ireland<disabled>SPC021/2005: 20090811, EXPIRES: 20200220
0148Netherlands<disabled>300148, 20110131, EXPIRES: 20160130
00032Netherlands<disabled>PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
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