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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. There are four patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are forty drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for VIREAD

US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	5
Bulk Api Vendors:	60
Clinical Trials:	53
Patent Applications:	1,646
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

Pharmacology for VIREAD

Ingredient-type	Nucleoside Analog
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

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

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

AC1O4QO8

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

D0R3FP

EX-A590

FT-0082876

fumaric acid bis[(isopropoxycarbonyl)oxy]methyl {[(2R)-1-(6-aminopurin-9-yl)propan-2-yl]oxy}methanephosphonate

FUMARIC ACID; PMPA PRODRUG

GS 4331-05

GS-4331-05

GS-US-104-0321

GSK-548470

GSK548470

HSDB 7165

HY-13782

I06-1886

KB-60712

KS-1246

LS-173814

MLS004774141

MolPort-009-679-412

MolPort-039-010-541

OR077617

OTT9J7900I

PMPA-oral

Q-201788

RP17795

RTR-009415

s1400

SC-24733

SCHEMBL2670560

SCHEMBL40021

SMR003500786

ST2413816

ST51053272

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

Tenofovirdisoproxilfumarate

Tenozet

TR-009415

UNII-OTT9J7900I

V1698

VCMJCVGFSROFHV-WZGZYPNHSA-N

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	021356-001	Oct 26, 2001	AB	RX	Yes	Yes
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	POWDER;ORAL	022577-001	Jan 18, 2012		RX	Yes	Yes
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	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	021356-002	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	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	021356-004	Jan 18, 2012
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-002	Jan 18, 2012

Paragraph IV (Patent) Challenges for VIREAD

Drugname	Dosage	Strength	RLD	Date
	Tablets	150 mg, 200 mg, and 250 mg
	Tablets	300 mg

International Patents for VIREAD

Country	Document Number	Estimated Expiration
New Zealand	333687
Luxembourg	91433
South Korea	100617608
China	101181277
Japan	2002511098

Supplementary Protection Certificates for VIREAD

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0803	Netherlands		PRODUCT NAME: TENOFOVIRALAFENAMIDE OF EEN ZOUT OF SOLVAAT DAARVAN, MET NAME TENOFOVIRALAFENAMIDEFUMARAAT; NATIONAL REGISTRATION NO/DATE: EU/1/15/1061/002 20151123; FIRST REGISTRATION: EU EU/1/15/1061/001 20151123
4 5022-2015	Slovakia		PRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2008 00023	Denmark
2016 00064	Denmark		PRODUCT NAME: RILPIVIRINHYDROCHLORID, EMTRICITABIN OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
90001-0	Sweden		PRODUCT NAME: COBICISTAT OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND TENOFOVIR ALAFENAMIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, IN PARTICULAR TENOFOVIR ALAFENAMIDE FUMARATE; REG. NO/DATE: EU/1/15/1061 20151123