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Tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for tenofovir disoproxil fumarate?

Tenofovir disoproxil fumarate is the generic ingredient in two branded drugs marketed by Teva Pharms Usa and Gilead Sciences Inc, and is included in three NDAs. There are four patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has seventy-nine patent family members in twenty-two countries.

There are thirty-three drug master file entries for tenofovir disoproxil fumarate. Five suppliers are listed for this compound. There are eight tentative approvals for this compound.

Summary for Generic Name: tenofovir disoproxil fumarate

Tradenames:2
Patents:5
Applicants:2
NDAs:3
Drug Master File Entries: see list33
Suppliers / Packagers: see list5
Bulk Api Vendors: see list51
Clinical Trials: see list379
Patent Applications: see list2,009
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:tenofovir disoproxil fumarate at DailyMed

Tentative approvals for TENOFOVIR DISOPROXIL FUMARATE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL300MG
► Subscribe► SubscribeTABLET; ORAL300MG
► Subscribe► SubscribeTABLET; ORAL300MG
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
TABLET;ORAL021356-003Jan 18, 2012RXYesNo5,922,695*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001RXYesYes6,043,230*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: tenofovir disoproxil fumarate

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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Non-Orange Book Patents for Generic Ingredient: tenofovir disoproxil fumarate

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
RE38333 Antiviral phosphonomethoxy nucleotide analogs having increased oral bioavailability► Subscribe
6,069,249 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 Ingredient: tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
Singapore106656► Subscribe
Australia8582798► Subscribe
Germany69809750► Subscribe
South Korea20060038451► Subscribe
Japan5398662► 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: TENOFOVIR DISOPROXIL FUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016 00066Denmark► SubscribePRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, EMTRICITABIN OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
2016 00065Denmark► SubscribePRODUCT NAME: EN KOMBINATION AF: RILPIVIRINHYDROCHLORID ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, OG TENOFOVIRALAFENAMID, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, SAERLIGT TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
C0032France► SubscribePRODUCT NAME: TENOFOVIR DISOPROXIL FUMARATE; EMTRICITABINE; REGISTRATION NO/DATE: EU/1/04/305/001 20050221
C0073France► SubscribePRODUCT NAME: COMBINAISON DE RILPIVIRINE OU SES FORMES THERAPEUTIQUEMENT EQUIVALENTES PROTEGEES PAR LE BREVET DE BASE TELLES QUE LES SELS PHARMACEUTIQUEMENT ACCEPTABLES DE RILPIVIRINE Y COMPRIS LE SEL D'ACIDE CHLORHYDRIQUE DE RILPIVIRINE DE TENOFOVIR EN PARTICULIER LE TENOFOVIR DISOPROXIL FUMARATE AINSI QUE D'EMTRICITABINE; REGISTRATION NO/DATE: EU/1/11/737/001-002 20111128
0767Netherlands► 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, EN TENOFOVIR, IN HET BIJZONDER TENOFOVIRDISOPROXILFUMARAAT; REGISTRATION NO/DATE: EU/1/11/737/001 20111128
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