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VIREAD Drug Profile

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Which patents cover Viread, and what generic alternatives are available?

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.

This drug has eighty-seven patent family members in twenty-two countries.

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

International Patents:	87
US Patents:	4
Applicants:	1
NDAs:	2
Suppliers / Packagers:	5
Bulk Api Vendors:	64
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

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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	021356-001	Oct 26, 2001
Gilead Sciences Inc	VIREAD	tenofovir disoproxil fumarate	TABLET;ORAL	021356-003	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

Non-Orange Book US Patents for VIREAD

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
6,069,249	Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability
RE38333	Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability

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International Patents for VIREAD

Country	Document Number	Estimated Expiration
Japan	2014159450
South Korea	100707505
Germany	122008000033
Japan	2013213071

Supplementary Protection Certificates for VIREAD

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
178	Luxembourg		91178, EXPIRES: 20200221
C/GB08/033	United Kingdom		PRODUCT NAME: TENOFOVIR DISOPROXIL AND THE SALTS (IN PARTICULAR THE FUMARATE), HYDRATES, TAUTOMERS AND SOLVATES THEREOF, TOGETHER WITH EMTRICITABINE AND EFAVIRENZ; REGISTERED: UK EU/1/07/430/001 20071213; REASON FOR LAPSE: SURRENDERED
C0021	France		PRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2015038	Lithuania		PRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128