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ATRIPLA Drug Profile

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Atripla is a drug marketed by Gilead and is included in one NDA. It is available from five suppliers. There are fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and seventy-nine patent family members in forty-seven countries.

The generic ingredient in ATRIPLA is efavirenz; emtricitabine; tenofovir disoproxil fumarate. There are twenty-three drug master file entries for this compound. Five suppliers are listed for this compound. There are five tentative approvals for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

Clinical Trials for: ATRIPLA

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, 2006RXYes8,592,397<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, 2006RXYes9,018,192<disabled> <disabled>
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Expired Patents for Tradename: ATRIPLA

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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, 20067,402,588*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, 20065,210,085*PED<disabled>
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Paragraph IV activity for: ATRIPLA

Drugname Dosage Strength RLD Submissiondate
efavirenz, emtricitabine and tenofovir disoproxil fumarateTablets600 mg/200 mg/300 mgAtripla12/29/2008

Non-Orange Book Patents for Tradename: ATRIPLA

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
5,728,575 Method of resolution of 1,3-oxathiolane nucleoside enantiomers<disabled in preview>
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds<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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International Patent Family for Tradename: ATRIPLA

Country Document Number Estimated Expiration
Canada2261619<disabled in preview>
South Korea20000029705<disabled in preview>
Slovenia1243593<disabled in preview>
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Supplementary Protection Certificates for Tradename: ATRIPLA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB08/033United Kingdom<disabled>PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
C/GB05/041United Kingdom<disabled>SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.
6Finland<disabled>
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