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Serving 500+ biopharmaceutical companies globally:

Deloitte
US Department of Justice
Colorcon
Federal Trade Commission
UBS
Farmers Insurance
Healthtrust
Moodys
Harvard Business School
Medtronic

Generated: August 23, 2017

DrugPatentWatch Database Preview

Sofosbuvir; velpatasvir - Generic Drug Details

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

Sofosbuvir; velpatasvir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir has three hundred and seventeen patent family members in forty-five countries.

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

Summary for Generic Name: sofosbuvir; velpatasvir

Tradenames:1
Patents:12
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packagers: see list1
Clinical Trials: see list219
Drug Prices:see low prices
DailyMed Link:sofosbuvir; velpatasvir at DailyMed
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
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: sofosbuvir; velpatasvir

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
9,156,823Antiviral compounds► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
8,957,046Nucleoside phosphoramidate prodrugs► Subscribe
8,563,530Purine nucleoside phosphoramidate► Subscribe
9,585,906Nucleoside phosphoramidate prodrugs► 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; velpatasvir

Country Document Number Estimated Expiration
Australia2010249481► Subscribe
TaiwanI583692► Subscribe
Slovenia2203462► Subscribe
Philippines12014502684► Subscribe
Japan2013542996► 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; VELPATASVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
14/065Ireland► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2014040Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0704Netherlands► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cerilliant
Queensland Health
Julphar
UBS
Dow
Citi
Teva
Johnson and Johnson
Cantor Fitzgerald
Deloitte

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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