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Last Updated: August 14, 2020

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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 two hundred and ninety-nine 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. Two suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

US ANDA Litigation and Generic Entry Outlook for Atripla

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

There have been twenty 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   Start Trial   Start Trial Y   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>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
0915894 C00915894/01 Switzerland   Start Trial PRODUCT NAME: TENOFOVIR DISOPROXILFUMARAT + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57316 21.03.2006
0915894 266 Finland   Start Trial
0582455 40/2000 Austria   Start Trial PRODUCT NAME: EFAVIRENZ, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES; NAT. REGISTRATION NO/DATE: EU/1/99/110/001-004 1/99/111/001-004 19990528; FIRST REGISTRATION: LI 54908 01, 54908 02, 54908 03 19981120
0513200 C00513200/01 Switzerland   Start Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0915894 91433 Luxembourg   Start Trial 91433, EXPIRES: 20220725
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
McKinsey
AstraZeneca
Dow
Express Scripts
Baxter

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