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Serving 500+ biopharmaceutical companies globally:

Covington
Merck
Citi
Farmers Insurance
US Department of Justice
Queensland Health
Accenture
Teva
Colorcon
Cantor Fitzgerald

Generated: July 21, 2017

DrugPatentWatch Database Preview

Sofosbuvir - Generic Drug Details

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What are the generic sources for sofosbuvir and what is the scope of sofosbuvir patent protection?

Sofosbuvir
is the generic ingredient in two branded drugs marketed by Gilead Sciences Inc and is included in two NDAs. There are fourteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has two hundred and fifty-three patent family members in forty-four countries.

There are four drug master file entries for sofosbuvir. One supplier is listed for this compound.

Summary for Generic Name: sofosbuvir

Tradenames:2
Patents:14
Applicants:1
NDAs:2
Drug Master File Entries: see list4
Suppliers / Packagers: see list1
Bulk Api Vendors: see list34
Clinical Trials: see list215
Patent Applications: see list117
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:sofosbuvir at DailyMed

Pharmacology for Ingredient: sofosbuvir

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
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes9,284,342► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes8,633,309► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes8,334,270► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes8,618,076► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sofosbuvir

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
9,585,906Nucleoside phosphoramidate prodrugs► Subscribe
8,735,569Nucleoside phosphoramidates► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
9,393,256Methods for treating HCV► Subscribe
9,206,217Nucleoside phosphoramidates► 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: sofosbuvir

Country Document Number Estimated Expiration
Japan2014196305► Subscribe
Japan2013527145► Subscribe
Eurasian Patent Organization026341► Subscribe
Australia2008232827► Subscribe
Eurasian Patent Organization201370186► 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: SOFOSBUVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462/01Switzerland► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Daiichi Sankyo
Fish and Richardson
Farmers Insurance
Queensland Health
QuintilesIMS
Citi
Mallinckrodt
Deloitte
AstraZeneca
US Army

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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