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Last Updated: November 4, 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 British ColumbiaPhase 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
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
Laurus EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 213541-001 Dec 22, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma EFAVIRENZ; EMTRICITABINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 201802-001 Oct 3, 2023 DISCN 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 Y ⤷  Sign Up
Macleods Pharms Ltd EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 204287-001 Sep 13, 2021 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Aurobindo Pharma EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 203041-001 Sep 4, 2018 AB RX No Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipla EFAVIRENZ, EMTRICITABINE, AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; emtricitabine; tenofovir disoproxil fumarate TABLET;ORAL 206894-001 Jun 3, 2019 AB RX No 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
Hong Kong 1217635 單位藥物劑型 (UNITARY PHARMACEUTICAL DOSAGE FORM) ⤷  Sign Up
Croatia P20140379 PRIPRAVCI I METODE ZA KOMBINIRANU ANTIVIRUSNU TERAPIJU (COMPOSITIONS AND METHODS FOR COMBINATION ANTIVIRAL THERAPY) ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2004064845 ⤷  Sign Up
Norway 20171193 Preparater og fremgangsmåter for antiviral kombinasjonsterapi ⤷  Sign Up
Brazil PI0611634 forma de dosagem farmacêutica unitária ⤷  Sign Up
South Korea 101151011 ⤷  Sign Up
Japan 4996241 ⤷  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 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
0915894 08C0020 France ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
0582455 C300032 Netherlands ⤷  Sign Up PRODUCT NAME: EFAVIRENZ; REGISTRATION NO/DATE: EU/1/99/110/001-004, EU/1/99/111/001-004 19990528
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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