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VIREAD Drug Profile

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Which patents cover Viread, and what substitute generic drugs 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 seventy-nine patent family members in twenty-two countries.

The generic ingredient in VIREAD is tenofovir disoproxil fumarate. There are thirty-three drug master file entries for this compound. Five suppliers are listed for this compound. There are eight tentative approvals for this compound. Additional details are available on the tenofovir disoproxil fumarate profile page.

Summary for Tradename: VIREAD

Patents:4
Applicants:1
NDAs:2
Suppliers / Packagers: see list5
Bulk Api Vendors: see list52
Clinical Trials: see list39
Patent Applications: see list1,403
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VIREAD at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes6,043,230*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001RXYesYes► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes5,922,695*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo5,922,695*PED► SubscribeY► Subscribe
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Expired Patents for Tradename: VIREAD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 20014,808,716► Subscribe
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Paragraph IV activity for: VIREAD

Drugname Dosage Strength RLD Submissiondate
tenofovir disoproxil fumarateTablets150 mg, 200 mg, and 250 mgViread5/17/2012
tenofovir disoproxil fumarateTablets300 mgViread1/26/2010

Non-Orange Book Patents for Tradename: 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► Subscribe
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: VIREAD

Country Document Number Estimated Expiration
Austria228526► Subscribe
Denmark1243593► Subscribe
Japan4628437► Subscribe
Germany69829010► Subscribe
China101239989► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: VIREAD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2012 00021Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT ADDITIONSSALT AF RILPIVIRIN, HERUNDER HYDROCHLORID ADDITIONSSALTET AF RILPIVIRIN, OG TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
2005 00032Denmark► Subscribe
0803Netherlands► SubscribePRODUCT 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
0768Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN RILPIVIRINE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN DIE BESCHERMD WORDT DOOR HET BASISOCTROOI, ZOALS EEN FARMACEUTISCH AANVAARDBAAR ZOUT VAN RILPIVIRINE, WAARONDER HET HYDROCHLORIDEZOUT VAN RILPIVIRINE. TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT. EN EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
2016009Lithuania► SubscribePRODUCT NAME: TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/15/1061/001 - 002 20151119
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