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Last Updated: April 2, 2020

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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, Macleods Pharms Ltd, Mylan Labs Ltd, and Mylan, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-six drug master file entries for efavirenz; lamivudine; tenofovir disoproxil fumarate. One supplier is 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
Yu-Jay Corp.Phase 3
Zhejiang UniversityN/A
Chongqing Public Health Medical CenterN/A

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 No No   Start Trial   Start Trial   Start Trial
Mylan SYMFI LO efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 208255-001 Feb 5, 2018 RX Yes Yes   Start Trial   Start Trial   Start 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   Start Trial   Start Trial   Start Trial
Mylan Labs Ltd SYMFI efavirenz; lamivudine; tenofovir disoproxil fumarate TABLET;ORAL 022142-001 Mar 22, 2018 RX Yes Yes   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

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
AstraZeneca
Moodys
Boehringer Ingelheim
McKesson
Baxter

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