Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
US Department of Justice
Citi
Mallinckrodt
Merck
Boehringer Ingelheim
Deloitte
Healthtrust
McKinsey

Generated: October 18, 2017

DrugPatentWatch Database Preview

EPCLUSA Drug Profile

« Back to Dashboard

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 thirteen patents protecting this drug.

This drug has three hundred and fifty-seven patent family members in forty-five countries and fourteen supplementary protection certificates in twelve countries.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are six 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► SubscribeY ► 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
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► 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
9,549,941Compositions and methods for treating hepatitis C virus► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,563,530Purine nucleoside phosphoramidate► Subscribe
9,637,512Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
9,156,823Antiviral compounds► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
9,221,833Antiviral compounds► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: EPCLUSA

Country Document Number Estimated Expiration
South Korea20150043553► Subscribe
Philippines12014502771► Subscribe
China105085592► Subscribe
Serbia54207► Subscribe
Mexico2016002185► Subscribe
African Regional IP Organization (ARIPO)201206535► Subscribe
Canada2817840► Subscribe
HungaryE027733► Subscribe
Japan2017132754► Subscribe
New Zealand603232► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: EPCLUSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2014Austria► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462/01Switzerland► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
C0082France► SubscribePRODUCT NAME: 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
2014 00061Denmark► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
4 5029-2014Slovakia► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Daiichi Sankyo
Queensland Health
Express Scripts
UBS
Fish and Richardson
Johnson and Johnson
Cerilliant
Dow
Teva

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot