Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 6, 2019

DrugPatentWatch Database Preview

Efavirenz; emtricitabine; tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic sources for efavirenz; emtricitabine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

Efavirenz; emtricitabine; tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences, Aurobindo Pharma Ltd, Cipla, and Teva Pharms Usa, and is included in four NDAs. There are nine patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Efavirenz; emtricitabine; tenofovir disoproxil fumarate has two hundred and ninety-seven patent family members in forty-three countries.

There are twenty-six drug master file entries for efavirenz; emtricitabine; tenofovir disoproxil fumarate. Four suppliers are listed for this compound. There are three tentative approvals for this compound.

Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate clinical trials

Recent Litigation for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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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

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate litigation

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

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate litigation

Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial600MG; 200MG; 300MGTABLET; ORAL
  Start Trial  Start Trial300MGTABLET; ORAL
  Start Trial  Start Trial200MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

US Patents and Regulatory Information for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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
Teva Pharms Usa EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091215-001 Nov 9, 2018 DISCN No No   Start Trial   Start Trial   Start Trial
Cipla EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206894-001 Jun 3, 2019 AB RX No No   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 efavirenz; emtricitabine; tenofovir disoproxil fumarate

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 SZ 7/2004 Austria   Start Trial
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
0513200 7/2004 Austria   Start Trial 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
0513200 122004000015 Germany   Start Trial PRODUCT NAME: EMTRIVA-EMTRICITABINE; REGISTRATION NO/DATE: EU/1/03/261/001-003 20031024
0582455 08C0021 France   Start Trial PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Express Scripts
Colorcon
McKesson
Dow
AstraZeneca
Johnson and Johnson

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