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Last Updated: July 29, 2021

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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 three hundred and one patent family members in forty-three countries.

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

Recent Clinical Trials for efavirenz; emtricitabine; tenofovir disoproxil fumarate

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

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

See all efavirenz; emtricitabine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free600MG; 200MG; 300MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free300MGTABLET; ORAL
⤷  Try it Free⤷  Try it Free200MGTABLET; 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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Cipla EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206894-001 Jun 3, 2019 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Aurobindo Pharma Ltd EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 AB RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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

International Patents for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Country Patent Number Estimated Expiration
World Intellectual Property Organization (WIPO) 9214743 ⤷  Try it Free
Austria 469147 ⤷  Try it Free
Australia 1437292 ⤷  Try it Free
Austria 219366 ⤷  Try it Free
Japan H10147586 ⤷  Try it Free
Hong Kong 1109861 ⤷  Try it Free
Germany 69233379 ⤷  Try it Free
>Country >Patent Number >Estimated Expiration

Supplementary Protection Certificates for efavirenz; emtricitabine; tenofovir disoproxil fumarate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0513200 C00513200/01 Switzerland ⤷  Try it Free PRODUCT NAME: EMTRICITABINE; REGISTRATION NUMBER/DATE: SWISSMEDIC 56880 25.10.2004
0582455 2001C/001 Belgium ⤷  Try it Free PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0513200 300148 Netherlands ⤷  Try it Free 300148, 20110131, EXPIRES: 20160130
0915894 SPC/GB08/033 United Kingdom ⤷  Try it Free 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
0915894 08C0020 France ⤷  Try it Free PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0513200 7/2004 Austria ⤷  Try it Free 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
0582455 08C0021 France ⤷  Try it Free 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:

Mallinckrodt
AstraZeneca
Boehringer Ingelheim
Moodys
Harvard Business School
Medtronic

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