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Last Updated: March 29, 2024

EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE - Generic Drug Details


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What are the generic drug sources for efavirenz; lamivudine; tenofovir disoproxil fumarate and what is the scope of patent protection?

Efavirenz; lamivudine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Aurobindo Pharma Ltd, Laurus, Macleods Pharms Ltd, Mylan Labs Ltd, and Mylan, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE
Recent Clinical Trials for EFAVIRENZ; LAMIVUDINE; 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
Professor Francois VenterPhase 3
Yu-Jay Corp.Phase 3

See all EFAVIRENZ; LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE clinical trials

US Patents and Regulatory Information for EFAVIRENZ; LAMIVUDINE; 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
Aurobindo Pharma Ltd EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022343-001 Aug 15, 2018 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan SYMFI LO efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 208255-001 Feb 5, 2018 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Macleods Pharms Ltd EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 210649-001 Mar 15, 2019 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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