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Last Updated: November 21, 2024

EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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What are the generic drug 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 four branded drugs marketed by Gilead Sciences, Aurobindo Pharma, Cipla, Hetero Labs Ltd V, Laurus, Macleods Pharms Ltd, Teva Pharms Usa, Strides Pharma, and Mylan, and is included in nine NDAs. There are seven 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 one hundred and twenty-three patent family members in thirty-one countries.

Seven suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

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

SponsorPhase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le SidaN/A
Yu-Jay Corp.Phase 3
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
⤷  Sign Up⤷  Sign Up600MG; 200MG; 300MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up300MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up200MGTABLET; 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 Strength NDA ANDAs Submitted Submissiondate
ATRIPLA Tablets efavirenz; emtricitabine; tenofovir disoproxil fumarate 600 mg/200 mg/300 mg 021937 1 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 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 DISCN Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Teva Pharms Usa EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 091215-001 Nov 9, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hetero Labs Ltd V EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203053-001 Jan 24, 2022 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilead Sciences ATRIPLA efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 021937-001 Jul 12, 2006 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 Title Estimated Expiration
New Zealand 564045 Stable fixed-dose formulations containing a combination of antivirals (emtricitabine and tenofovir DF), method for producing thereof using dry granulation ⤷  Sign Up
Australia 2009200414 Compositions and methods for combination antiviral therapy ⤷  Sign Up
Austria E419839 ⤷  Sign Up
Portugal 1890681 ⤷  Sign Up
Japan 2014037430 COMPOSITION AND METHOD FOR COMBINED ANTIVIRAL THERAPY ⤷  Sign Up
Mexico 2007015764 FORMULACIONES ESTABLES CON DOSIS FIJA QUE CONTIENEN UNA COMBINACION DE ANTIVIRALES, METODO PARA PRODUCIRLAS USANDO GRANULACION EN SECO. (STABLE FIXED-DOSE FORMULATIONS CONTAINING A COMBINATION OF ANTIVIRALS, METHOD FOR PRODUCING THEREOF USING DRY GRANULATION.) ⤷  Sign Up
China 104523713 Stable fixed-dose formulations containing a combination of antivirals, method for producing thereof using dry granulation ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0582455 2001C/001 Belgium ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; NATL. REGISTRATION NO/DATE: EU/1/99/110/001 19990604; FIRST REGISTRATION: CH 54908 01 19981120
0582455 C300032 Netherlands ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
0915894 08C0020 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455 08C0021 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0915894 SPC/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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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