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Serving leading biopharmaceutical companies globally:

Moodys
Harvard Business School
Teva
Merck
Chubb
Fish and Richardson
US Department of Justice
Baxter
AstraZeneca
Johnson and Johnson

Generated: February 19, 2018

DrugPatentWatch Database Preview

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 and is included in one NDA. There are sixteen patents protecting this drug and one Paragraph IV challenge.

This drug has four hundred and twenty-three patent family members in forty-seven countries.

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

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 ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for ATRIPLA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Gilead ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Paragraph IV (Patent) Challenges for ATRIPLA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 600 mg/200 mg/300 mg ➤ Subscribe 12/29/2008

Non-Orange Book US Patents for 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
6,153,751 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
7,053,100 Therapeutic nucleosides ➤ Sign Up
5,204,466 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,539,116 Method and compositions for the synthesis of BCH-189 and related compounds ➤ Sign Up
5,852,027 Antiviral 1,3-dioxolane nucleoside analogues ➤ Sign Up
6,069,249 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability ➤ Sign Up
8,871,271 Method and composition for pharmaceutical product ➤ Sign Up
7,160,999 Method of resolution and antiviral activity of 1,3-oxathiolane nucleoside enantiomers ➤ Sign Up
6,114,343 Antiviral activity and resolution of 2-hydroxymethyl-5-(5-flurocytosin-1-yl)-1,3-oxathiolane ➤ Sign Up
5,700,937 Method for the synthesis, compositions and use of 2'-deoxy-5-fluoro-3'-thiacytidine and related compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ATRIPLA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2005 00032 Denmark ➤ Sign Up
C/GB08/033 United Kingdom ➤ Sign Up 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
178 Luxembourg ➤ Sign Up 91178, EXPIRES: 20200221
2004 Austria ➤ Sign Up PRODUCT NAME: EMTRICITABIN; NAT. REGISTRATION NO/DATE: EU/1/03/261/001- EU/1/03/261/003 20031024; FIRST REGISTRATION: EU EU/1/03/261/003
433 Luxembourg ➤ Sign Up 91433, EXPIRES: 20220725
C/GB04/016 United Kingdom ➤ Sign Up PRODUCT NAME: EMTRICITABINE OR SALTS AND ESTERS THEREOF; REGISTERED: UK EU/1/03/261/001 20031024; UK EU/1/03/261/002 20031024; UK EU/1/03/261/003 20031024
C018/2008 Ireland ➤ Sign Up SPC018/2008: 20090811, EXPIRES: 20220724
C0032 France ➤ Sign Up PRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
073 Luxembourg ➤ Sign Up 91073, EXPIRES: 20160131
2008 00023 Denmark ➤ Sign Up
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Accenture
Fish and Richardson
Fuji
Medtronic
Healthtrust
UBS
Federal Trade Commission
Cantor Fitzgerald
Chinese Patent Office

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