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Serving 500+ biopharmaceutical companies globally:

Boehringer Ingelheim
US Department of Justice
Accenture
Moodys
Mallinckrodt
Cerilliant
McKinsey
Baxter
Merck
Express Scripts

Generated: August 16, 2017

DrugPatentWatch Database Preview

EPCLUSA Drug Profile

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What is the patent landscape for Epclusa, and when can generic versions of Epclusa launch?

Epclusa is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are twelve patents protecting this drug.

This drug has three hundred and fifteen patent family members in forty-five countries.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir profile page.
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► Subscribe ► 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► SubscribeY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: EPCLUSA

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
9,637,512Nucleoside phosphoramidates► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
9,051,340Antiviral compounds► 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: EPCLUSA

Country Document Number Estimated Expiration
Japan2015205903► Subscribe
Denmark2552930► Subscribe
Japan2016023187► Subscribe
China105085592► Subscribe
China103328480► 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: EPCLUSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; 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
90066-6Sweden► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2014 00061Denmark► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
C0082France► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 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:

Boehringer Ingelheim
Moodys
Medtronic
Baxter
Healthtrust
Argus Health
QuintilesIMS
Cantor Fitzgerald
Federal Trade Commission
Cerilliant

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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