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Last Updated: January 22, 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

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

There have been twenty-three 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.

Drug patent expirations by year for ATRIPLA
Drug Prices for ATRIPLA

See drug prices for ATRIPLA

Recent Clinical Trials for ATRIPLA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of AlbertaPhase 4
Yu-Jay Corp.Phase 3
University of British ColumbiaPhase 4

See all ATRIPLA clinical trials

Recent Litigation for ATRIPLA

Identify potential future generic entrants

District Court Litigation
Case NameDate
GILEAD SCIENCES, INC. v. ZYDUS PHARMACEUTICALS (USA) INC.2019-01-15
GILEAD SCIENCES, INC. v. STRIDES PHARMA, INC.2018-06-27
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd.2018-05-18

See all ATRIPLA litigation

PTAB Litigation
PetitionerDate
Mylan Pharmaceuticals Inc.2014-06-04

See all ATRIPLA litigation

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 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
>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

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

Supplementary Protection Certificates for ATRIPLA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894 SPC/GB08/033 United Kingdom   Start Trial 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
0513200 C00513200/01 Switzerland   Start Trial PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0513200 SPC/GB04/016 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
Baxter
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Boehringer Ingelheim
AstraZeneca
Moodys

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