Tenofovir disoproxil fumarate - Generic Drug Details

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

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc, Aurobindo Pharma, Casi Pharms Inc, Chartwell, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Qilu, Strides Pharma, and Teva Pharms Usa, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for tenofovir disoproxil fumarate. Fourteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for tenofovir disoproxil fumarate

US Patents:	0
Tradenames:	2
Applicants:	11
NDAs:	12
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	85
Clinical Trials:	388
Patent Applications:	7,011
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for tenofovir disoproxil fumarate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for tenofovir disoproxil fumarate
What excipients (inactive ingredients) are in tenofovir disoproxil fumarate?	tenofovir disoproxil fumarate excipients list
DailyMed Link:	tenofovir disoproxil fumarate at DailyMed

See drug prices for tenofovir disoproxil fumarate

Recent Clinical Trials for tenofovir disoproxil fumarate

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

Sponsor	Phase
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 3
Beatriz Grinsztejn	Phase 3
Thiago Torres	Phase 3

See all tenofovir disoproxil fumarate clinical trials

Generic filers with tentative approvals for TENOFOVIR DISOPROXIL FUMARATE

Applicant	Application No.	Strength	Dosage Form
		300MG	TABLET; ORAL
		300MG	TABLET;ORAL
		250MG	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 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 tenofovir disoproxil fumarate

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

Paragraph IV (Patent) Challenges for TENOFOVIR DISOPROXIL FUMARATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIREAD	Tablets	tenofovir disoproxil fumarate	150 mg, 200 mg, and 250 mg	021356	1	2012-05-17
VIREAD	Tablets	tenofovir disoproxil fumarate	300 mg	021356	1	2010-01-26

US Patents and Regulatory Information for 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
Teva Pharms Usa	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	091612-002	Jan 26, 2018	AB	RX	No	No
Strides Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090742-001	Jan 26, 2018	AB	RX	No	No
Aurobindo Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-003	Jan 26, 2018	AB	RX	No	No
Qilu	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	209498-003	Mar 2, 2018	AB	RX	No	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	RX	Yes	No
Aurobindo Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-002	Jan 26, 2018	AB	RX	No	No
Mylan	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	206569-001	Nov 27, 2018		DISCN	No	No

Expired US Patents for tenofovir disoproxil fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001