Efavirenz; lamivudine; tenofovir disoproxil fumarate - Generic Drug Details

What are the generic drug sources for efavirenz; lamivudine; tenofovir disoproxil fumarate and what is the scope of freedom to operate?

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

US Patents:	0
Tradenames:	3
Applicants:	5
NDAs:	6
Finished Product Suppliers / Packagers:	2
Clinical Trials:	28
DailyMed Link:	efavirenz; lamivudine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for efavirenz; lamivudine; tenofovir disoproxil fumarate

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

Sponsor	Phase
Centre de Recherches et d'Etude sur la Pathologie Tropicale et le Sida	N/A
Professor Francois Venter	Phase 3
Yu-Jay Corp.	Phase 3

See all efavirenz; lamivudine; tenofovir disoproxil fumarate clinical trials

Pharmacology for efavirenz; lamivudine; tenofovir disoproxil fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Cytochrome P450 2B6 Inducers Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A Inducers Cytochrome P450 3A4 Inhibitors Non-Nucleoside Reverse Transcriptase Inhibitors Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for efavirenz; lamivudine; tenofovir disoproxil fumarate

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

J05AG	Non-nucleoside reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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
Macleods Pharms Ltd	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	210649-001	Mar 15, 2019		DISCN	No	No
Laurus	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	212786-001	May 14, 2020	AB	RX	No	No
Laurus	EFAVIRENZ, LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	efavirenz; lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	213038-001	May 14, 2020	AB	RX	No	No