VIREAD Drug Patent Profile

When do Viread patents expire, and when can generic versions of Viread launch?

Viread is a drug marketed by Gilead Sciences Inc and is included in two NDAs.

The generic ingredient in VIREAD 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.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Viread

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

Summary for VIREAD

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	91
Patent Applications:	4,317
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIREAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD
What excipients (inactive ingredients) are in VIREAD?	VIREAD excipients list
DailyMed Link:	VIREAD at DailyMed

See drug prices for VIREAD

Recent Clinical Trials for VIREAD

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

Sponsor	Phase
Université Protestant au Congo	Phase 4
Doris Duke Charitable Foundation	Phase 4
Albert Einstein College of Medicine	Phase 4

See all VIREAD clinical trials

Pharmacology for VIREAD

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 VIREAD

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 VIREAD

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 VIREAD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	POWDER;ORAL	022577-001	Jan 18, 2012		RX	Yes	Yes
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-004	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012	AB	RX	Yes	No
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-001	Oct 26, 2001	AB	RX	Yes	Yes

Expired US Patents for VIREAD

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	POWDER;ORAL	022577-001	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012

International Patents for VIREAD

See the table below for patents covering VIREAD around the world.

Country	Patent Number	Title	Estimated Expiration
Netherlands	300344
Taiwan	I242561
Canada	2298059	COMPOSITION D'ANALOGUES DE NUCLEOTIDES ET PROCEDE DE SYNTHESE (NUCLEOTIDE ANALOG COMPOSITION AND SYNTHESIS METHOD)
Canada	2574904	ANALOGUES DE NUCLEOTIDES ENANTIOMERES ANTIRETROVIRAUX (ANTIRETROVIRAL ENANTIOMERIC NUCLEOTIDE ANALOGS)
Australia	713374

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2487166	PA2016038,C2487166	Lithuania		PRODUCT NAME: KOBICISTATAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA IR TENOFOVIRO ALAFENAMIDAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA, YPAC TENOFOVIRO ALAFENAMIDO FUMARATAS; REGISTRATION NO/DATE: EU/1/15/1061 20151119
1663240	CA 2016 00063	Denmark		PRODUCT NAME: RILPIVIRIN ELLER TERAPEUTISK AEKVIVALENT FORM DERAF BESKYTTET AF GRUNDPATENTET SASOM ET FARMACEUTISK ACCEPTABELT SALT FX HYDROCHLORIDSALTET AF RILPIVIRIN OG TENOFOVIRALAFENAMID ELLER FARMACEUTISK ACCEPTABELT SALT DERAF FX TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
1301519	PA2016009	Lithuania		PRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
1663240	PA2015038,C1663240-3	Lithuania		PRODUCT NAME: RILPIVIRINO ARBA TERAPINIU POZIURIU PRIIMTINOS JO FORMOS, TOKIOS KAIP RILPIVIRINO DRUSKOS,ISKAITANT RILPIVIRINO HIDROCHLORIDA, IR TENOFOVIRO, YPAC TENOFOVIRO DIZOPROKSILIO FUMARATO, DERINYS; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122