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VIREAD Drug Profile

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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. Sixteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

US ANDA 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
Suppliers / Packagers:	3
Bulk Api Vendors:	70
Clinical Trials:	63
Patent Applications:	1,948
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VIREAD
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VIREAD
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
Third Affiliated Hospital, Sun Yat-Sen University	N/A
Ohio State University	Phase 4
University of North Carolina, Chapel Hill	Phase 4

See all VIREAD clinical trials

Recent Litigation for VIREAD

Identify potential future generic entrants

District Court Litigation

Case Name	Date
United States v. Gilead Sciences, Inc.	2019-11-06
Gilead Sciences, Inc. v. Merck & Co., Inc.	2016-07-06
Gilead Sciences v. Sigmapharm Labs	2014-05-05

See all VIREAD litigation

PTAB Litigation

Petitioner	Date
	2014-06-04

See all VIREAD litigation

Pharmacology for VIREAD

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

Synonyms for VIREAD

(R)-(((((1-(6-amino-9H-purin-9-yl)propan-2-yl)oxy)methyl)phosphoryl)bis(oxy))bis(methylene) diisopropyl bis(carbonate) fumarate

(R)-5-((2-(6-Amino-9H-purin-9-yl)-1-methylethoxy)methyl)-2,4,6,8-tetraoxa-5-phosphanonanedioic acid, bis(1-methylethyl) ester, 5-oxide, (E)-2-butenedioate (1:1)

[[(1R)-2-(6-aminopurin-9-yl)-1-methyl-ethoxy]methyl-(isopropoxycarbonyloxymethoxy)phosphoryl]oxymethyl isopropyl carbonate; fumaric acid

[[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxymethyl-(propan-2-yloxycarbonyloxymethoxy)phosphoryl]oxymethyl propan-2-yl carbonate;(E)-but-2-enedioic acid

2,4,6,8-Tetraoxa-5-phosphanonanedioic acid, 5-[[(1R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy]methyl]-, 1,9-bis(1-methylethyl) ester, 5-oxide, (2E)-2-butenedioate (1:1)

202138-50-9

9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate

9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine fumarate (1:1)

9-((R)-2-((Bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine, fumarate

9-((R)-2-((bis(((isopropoxycarbonyl)oxy)methoxy)phosphinyl)methoxy)propyl)adenine,fumarate

AB0020710

AB2000088

ACN-028819

AK-51342

AKOS016340707

AKOS025149493

AM20090676

AOB5580

AT-15317

BCP0726000258

bis({[(propan-2-yloxy)carbonyl]oxy}methyl) ({[(2R)-1-(6-amino-9H-purin-9-yl)propan-2-yl]oxy}methyl)phosphonate (2E)-but-2-enedioate

Bis(hydroxymethyl) (((R)-2-(6-amino-9H-purin-9-yl)-1-methylethoxy)methyl)phosphonate, bis(isopropyl carbonate) (ester), fumarate (1:1)

C19H30N5O10P.C4H4O4

CHEBI:63718

CHEMBL1486

CS-1346

CT0141

D01982

EX-A590

FT-0082876

GS 4331-05

GS-1278 Disoproxil Fumarate

GS-4331-05

GS-4331-05-

GS-US-104-0321

GSK-548470

HSDB 7165

HY-13782

KS-1246

LS-173814

MLS004774141

OTT9J7900I

PMPA-PRODRUG

Q-201788

Q27132754

RTR-009415

s1400

SC-24733

SCHEMBL2670560

SCHEMBL40021

SMR003500786

ST2413816

Tenofovir (Disoproxil Fumarate)

Tenofovir DF

Tenofovir Disoproxil Fumarate

Tenofovir disoproxil fumarate (JAN/USAN)

Tenofovir Disoproxil Fumarate [USAN]

Tenofovir disoproxil fumarate, >=98% (HPLC)

Tenofovir disoproxil fumarate, 98%

Tenofovir disoproxil fumarate, Pharmaceutical Secondary Standard; Certified Reference Material

tenofovir-disoproxil-fumarate

TR-009415

UNII-OTT9J7900I

V1698

VCMJCVGFSROFHV-WZGZYPNHSA-N

Viread (TN)

Paragraph IV (Patent) Challenges for VIREAD

Tradename	Dosage	Ingredient	NDA	Submissiondate
VIREAD	TABLET;ORAL	tenofovir disoproxil fumarate	021356	2012-05-17
VIREAD	TABLET;ORAL	tenofovir disoproxil fumarate	021356	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	021356-004	Jan 18, 2012	AB	RX	Yes	No
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	021356-002	Jan 18, 2012	AB	RX	Yes	No

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	021356-004	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	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	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	Jan 18, 2012

International Patents for VIREAD

Country	Patent Number	Estimated Expiration
Portugal	998480
Japan	4173202
Hong Kong	213296
Singapore	106656
Spain	2249511
Japan	2011016847

Supplementary Protection Certificates for VIREAD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	19C1025	France		PRODUCT NAME: DORAVIRINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES EN COMBINAISON AVEC LE LAMIVUDINE EN COMBINAISON AVEC LE TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333 20181126
2487166	17C1001	France		PRODUCT NAME: COBICISTAT OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE ET TENOFOVIR ALAFENAMIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
1419152	132012902054377	Italy		PRODUCT NAME: EMTRICITABINA/RILPIVIRINA CLORIDRATO/TENOFOVIR DISOPROXIL FUMARATO(EVIPLERA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/737/001-002, 20111128
1663240	93382	Luxembourg		PRODUCT NAME: COMBINAISON DE RILPIVIRINE OU UNE FORME THERAPEUTIQUE EQUIVALENTE QUI EN DERIVE TELLE QUE PROTEGEE PAR LE BREVET DE BASE, TEL QU'UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE RILPIVIRINE, INCLUANT LE SEL CHLORHYDRATE DE RILPIVIRINE ET TENOFOVIR ALAFENAMIDE, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; AUTHORISATION NUMBER AND DATE: EU/1/16/1112 ODEFSEY - EMTRICITABINE
1663240	PA2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
0915894	SPC/GB05/041	United Kingdom		SUPPLEMENTARY PROTECTION CERTIFICATE NO SPC/GB05/041 GRANTED TO GILEAD SCIENCES, INC. IN RESPECT OF THE PRODUCT COMPOSITION CONTAINING BOTH TENOFOVIR DISOPROXIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE, TAUTOMER OR SOLVATE THEREOF, TOGETHER WITH EMTRICITABINE , THE GRANT OF WHICH WAS ADVERTISED IN JOURNAL NO 6233 DATED 05/11/2008 HAS HAD ITS MAXIMUM PERIOD OF DURATION CORRECTED, SUBJECT TO THE PAYMENT OF THE PRESCRIBED FEES IT WILL EXPIRE ON 23/02/2020.