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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Express Scripts
Covington
Novartis
Cantor Fitzgerald
Cipla
McKinsey
Federal Trade Commission
McKesson
Chubb

Generated: October 23, 2017

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Tenofovir disoproxil fumarate - Generic Drug Details

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What are the generic sources for tenofovir disoproxil fumarate and what is the scope of tenofovir disoproxil fumarate patent protection?

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.

Tenofovir disoproxil fumarate has eighty-seven patent family members in twenty-two countries and sixty-three supplementary protection certificates in twelve countries.

There are thirty-six drug master file entries for tenofovir disoproxil fumarate. Four suppliers are listed for this compound. There are nine tentative approvals for this compound.

Summary for Generic Name: tenofovir disoproxil fumarate

US Patents:4
Tradenames:2
Applicants:2
NDAs:3
Drug Master File Entries: see list36
Suppliers / Packagers: see list4
Bulk Api Vendors: see list51
Clinical Trials: see list896
Patent Applications: see list3,531
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. Strength Dosage Form
u► Subscribe300MGTABLET; ORAL
u► Subscribe300MGTABLET; ORAL
u► Subscribe300MGTABLET; ORAL
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;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001ABRXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
POWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-003Jan 18, 2012RXYesNo► Subscribe► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► 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, 2001► Subscribe► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001► Subscribe► 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
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 Ingredient: tenofovir disoproxil fumarate

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9804569► Subscribe
Japan2011016847► Subscribe
South Korea100617608► Subscribe
Japan4033494► Subscribe
China101239989► Subscribe
Japan2008208126► Subscribe
Australia713374► Subscribe
European Patent Office1243593► Subscribe
Spain2249511► Subscribe
South Korea20060038451► 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
0852Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN: - RILPIVIRINEHYDROCHLORIDE OF EEN THERAPEUTISCH EQUIVALENTE VORM DAARVAN ZOALS BESCHERMD DOOR HET BASISOCTROOI; - EMTRICITABINE; EN - TENOFOVIRALAFENAMIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, IN HET BIJZONDER TENOFOVIRALAFENAMIDEFUMARAAT; REGISTRATION NO/DATE: EU/1/16/1112 20160623
2015037Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM + EMTRICITABINUM; REGISTRATION NO/DATE: EU/1/11/737/001 2011 11 28, EU/1/11/737/002 20111128
854Luxembourg► SubscribePRODUCT 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, EN PARTICULIER LE FUMARATE DE TENOFOVIR DISOPROXIL
2005 00032Denmark► Subscribe
2012009,C1419152Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28 EU/1/11/737/002 20111128
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
2016000109Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRIN ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON, Z.B. EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ VON RILPIVIRIN, EINSCHLIESSLICH DES HYDROCHLORIDSALZES VON RILPIVIRIN. EMTRICITABIN UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
C0013France► SubscribePRODUCT NAME: TENOFOVIR ALAFENAMIDE OU UN SEL OU UN SOLVATE DE TENOFOVIR ALAFENAMIDE,EN PARTICULIER LE FUMARATE DE TENOFOVIR ALAFENAMIDE; REGISTRATION NO/DATE: EU/1/15/1061 20151123
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
2015038Lithuania► SubscribePRODUCT NAME: RILPIVIRINUM + TENOFOVIRUM DISOPROXILUM; REGISTRATION NO/DATE: EU/1/11/737/001, 2011 11 28, EU/1/11/737/002 20111128
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Serving leading biopharmaceutical companies globally:

Merck
Healthtrust
Julphar
McKinsey
Colorcon
Moodys
Harvard Business School
Cerilliant
Daiichi Sankyo
Fuji

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