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Last Updated: May 10, 2021

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ATRIPLA Drug Profile

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When do Atripla patents expire, and when can generic versions of Atripla launch?

Atripla is a drug marketed by Gilead Sciences and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and one patent family members in forty-three countries.

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

DrugPatentWatch® Generic Entry Outlook for Atripla

Atripla was eligible for patent challenges on July 2, 2007.

There have been eighteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are three tentative approvals for the generic drug (efavirenz; emtricitabine; tenofovir disoproxil fumarate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Paragraph IV (Patent) Challenges for ATRIPLA
Tradename Dosage Ingredient NDA Submissiondate
ATRIPLA TABLET;ORAL efavirenz; emtricitabine; tenofovir disoproxil fumarate 021937 2008-12-29

US Patents and Regulatory Information for ATRIPLA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ATRIPLA

Supplementary Protection Certificates for ATRIPLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 SPC/GB08/022 United Kingdom   Get Started for $10 PRODUCT 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
0915894 C00915894/01 Switzerland   Get Started for $10 PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
0915894 SPC/GB05/041 United Kingdom   Get Started for $10 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.
0915894 08C0020 France   Get Started for $10 PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894 SPC021/2005 Ireland   Get Started for $10 SPC021/2005: 20090811, EXPIRES: 20200220
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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AstraZeneca
Dow
Express Scripts
Baxter

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