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Last Updated: November 21, 2019

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 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-seven 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. Four suppliers are listed for this compound. Additional details are available on the efavirenz; emtricitabine; tenofovir disoproxil fumarate profile page.

Drug patent expirations by year for ATRIPLA
Drug Prices for ATRIPLA

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Recent Clinical Trials for ATRIPLA

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

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Recent Litigation for ATRIPLA

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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

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

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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 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

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
0582455 2001C/001 Belgium   Start Trial PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0513200 91073 Luxembourg   Start Trial 91073, EXPIRES: 20160131
0582455 C300032 Netherlands   Start Trial PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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