TENOFOVIR DISOPROXIL FUMARATE Drug Patent Profile

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Tenofovir Disoproxil Fumarate is a drug marketed by Aurobindo Pharma, Casi Pharms Inc, Chartwell, Cipla, Hetero Labs Ltd Iii, Macleods Pharms Ltd, Mylan, Mylan Labs Ltd, Qilu, Reyoung, Strides Pharma, and Teva Pharms Usa. and is included in twelve NDAs.

The generic ingredient in TENOFOVIR DISOPROXIL FUMARATE is tenofovir disoproxil fumarate. There are forty-two drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

A generic version of TENOFOVIR DISOPROXIL FUMARATE was approved as tenofovir disoproxil fumarate by TEVA PHARMS USA on March 18^th, 2015.

US Patents:	0
Applicants:	12
NDAs:	12
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	391
Patent Applications:	4,775
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TENOFOVIR DISOPROXIL FUMARATE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TENOFOVIR DISOPROXIL FUMARATE
DailyMed Link:	TENOFOVIR DISOPROXIL FUMARATE at DailyMed

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Sponsor	Phase
Chiang Mai University, Thailand	Phase 3
Assistance Publique - Hôpitaux de Paris, FRANCE	Phase 3
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Phase 3

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

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

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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-001	Jan 26, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Reyoung	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	211337-001	Mar 2, 2023	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	078800-001	Jan 26, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aurobindo Pharma	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	090647-004	Jan 26, 2018	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mylan	TENOFOVIR DISOPROXIL FUMARATE	tenofovir disoproxil fumarate	TABLET;ORAL	206569-003	Nov 27, 2018		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