Lamivudine; tenofovir disoproxil fumarate - Generic Drug Details

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

Lamivudine; tenofovir disoproxil fumarate is the generic ingredient in three branded drugs marketed by Mylan Labs Ltd, Aurobindo Pharma Ltd, and Chartwell Rx, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound. There are seven tentative approvals for this compound.

Summary for lamivudine; tenofovir disoproxil fumarate

US Patents:	0
Tradenames:	3
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	1
Clinical Trials:	81
DailyMed Link:	lamivudine; tenofovir disoproxil fumarate at DailyMed

Recent Clinical Trials for 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
Merck Sharp & Dohme LLC	Phase 3
Prism Health North Texas	Phase 3

See all lamivudine; tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for LAMIVUDINE; TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		300MG; 300MG	TABLET; ORAL
		300MG; 300MG; 200MG	TABLET; ORAL
		300MG; 300MG	TABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for lamivudine; tenofovir disoproxil fumarate

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for 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

US Patents and Regulatory Information for 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
Mylan Labs Ltd	CIMDUO	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022141-001	Feb 28, 2018		RX	Yes	Yes
Chartwell Rx	TEMIXYS	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	211284-001	Nov 16, 2018		DISCN	Yes	No
Aurobindo Pharma Ltd	LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE	lamivudine; tenofovir disoproxil fumarate	TABLET;ORAL	022344-001	May 15, 2018		DISCN	Yes	No