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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
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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 five 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 patent family members in twenty-two countries.

There are thirty-three 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

Tradenames:2
Patents:5
Applicants:2
NDAs:3
Drug Master File Entries: see list33
Suppliers / Packagers: see list4
Bulk Api Vendors: see list51
Clinical Trials: see list876
Patent Applications: see list3,346
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
► Subscribe► Subscribe300MGTABLET; ORAL
► Subscribe► Subscribe300MGTABLET; ORAL
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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
TABLET;ORAL021356-004Jan 18, 2012RXYesNo5,922,695*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-004Jan 18, 2012RXYesNo5,977,089*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001ABRXYesYes5,922,695*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 2001ABRXYesYes6,043,230*PED► SubscribeY► Subscribe
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-003Jan 18, 2012RXYesNo5,977,089*PED► SubscribeY► 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
Gilead Sciences Inc
VIREAD
tenofovir disoproxil fumarate
TABLET;ORAL021356-001Oct 26, 20016,057,305► 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
South Korea100707505► Subscribe
Denmark1243593► Subscribe
China100383148► Subscribe
European Patent Office0915894► Subscribe
European Patent Office1243593► 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 00063Denmark► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
C0020France► SubscribePRODUCT NAME: EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/07/430/001 20071213
2016042Lithuania► SubscribePRODUCT NAME: RILPIVIRINO HIDROCHLORIDAS + EMTRICITABINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
C/GB08/033United Kingdom► SubscribePRODUCT 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
2015 00055Denmark► SubscribePRODUCT NAME: KOMBINATION AF RILPIVIRIN ELLER EN TERAPEUTISK AEKVIVALENT FORM DERAF, SOM ER BESKYTTET AF GRUNDPATENTET, SASOM ET FARMECEUTISK ACCEPTABELT SALT AF RILPIVIRIN, HERUNDER HYDROCHLORIDSALTET AF RILPIVIRIN, TENOFOVIR, NAVNLIG TENOFOVIRDISOPROXILFUMARAT; REG. NO/DATE: EU/1/11/737/001-002 20111128
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
UBS
Novartis
Citi
Deloitte
Baxter
Dow
McKesson
US Department of Justice
Accenture

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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