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Serving leading biopharmaceutical companies globally:

AstraZeneca
Julphar
Citi
Federal Trade Commission
Queensland Health
Express Scripts
Farmers Insurance
McKinsey
UBS
US Army

Generated: December 13, 2017

DrugPatentWatch Database Preview

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 and sixty-four supplementary protection certificates in twelve countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumaratePOWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-003Jan 18, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-004Jan 18, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumaratePOWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumaratePOWDER;ORAL022577-001Jan 18, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-002Jan 18, 2012RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: VIREAD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
Gilead Sciences IncVIREADtenofovir disoproxil fumarateTABLET;ORAL021356-001Oct 26, 2001► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
Hong Kong1020964► Subscribe
China1554350► Subscribe
European Patent Office1243593► Subscribe
Brazil9811045► Subscribe
China100383148► Subscribe
Canada2605226► Subscribe
Luxembourg91178► Subscribe
China101239989► Subscribe
Luxembourg91433► 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: VIREAD

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0915894/02Switzerland► SubscribePRODUCT NAME: TENOFOVIRDISOPROXIL + EFAVIRENZ + EMTRICITABIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 60011 20.11.2009
2016000108Germany► 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, UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
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
2016 00063Denmark► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID OG TENOFOVIRALAFENAMIDFUMARAT; REG. NO/DATE: EU/1/16/1112/001 20160623
2016045Lithuania► SubscribePRODUCT NAME: RILPIVIRINAS + TENOFOVIRO ALAFENAMIDAS; REGISTRATION NO/DATE: EU/1/16/1112 20160621
4 5022-2015Slovakia► SubscribePRODUCT NAME: RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
2016000110Germany► SubscribePRODUCT NAME: KOMBINATION VON RILPIVIRINHYDROCHLORID ODER EINER THERAPEUTISCH AEQUIVALENTEN, DURCH DAS GRUNDPATENT GESCHUETZTEN FORM DAVON UND TENOFOVIRALAFENAMID ODER EINEM PHARMAZEUTISCH AKZEPTABLEN SALZ DAVON, INSBESONDERE TENOFOVIRALAFENAMIDFUMARAT; REGISTRATION NO/DATE: EU/1/16/1112 20160621
2005 00032Denmark► Subscribe
3 5021-2015Slovakia► SubscribePRODUCT NAME: EMTRICITABIN/RILPIVIRINHYDROCHLORID/TENOFOVIRDIZOPROXILFUMARAT; REGISTRATION NO/DATE: EU/1/11/737/001 - EU/1/11/737/002 20111128
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
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Serving leading biopharmaceutical companies globally:

McKinsey
Baxter
Accenture
Farmers Insurance
Daiichi Sankyo
Moodys
Cantor Fitzgerald
UBS
Julphar
Citi

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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