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Serving leading biopharmaceutical companies globally:

US Army
Cantor Fitzgerald
McKesson
McKinsey
Harvard Business School
Federal Trade Commission
Dow
Baxter
Teva
Cerilliant

Generated: December 11, 2017

DrugPatentWatch Database Preview

EPCLUSA Drug Profile

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When do Epclusa patents expire, 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-eight 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.

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 IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Gilead Sciences IncEPCLUSAsofosbuvir; velpatasvirTABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► 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
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
9,051,340Antiviral compounds► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
9,156,823Antiviral compounds► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
9,393,256Methods for treating HCV► Subscribe
8,563,530Purine nucleoside phosphoramidate► Subscribe
9,221,833Antiviral 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
European Patent Office2709613► Subscribe
Germany202012013382► Subscribe
China106166160► Subscribe
Mexico2012011171► Subscribe
Brazil112014006324► Subscribe
European Patent Office2824109► Subscribe
Japan2015028060► Subscribe
Chile2014001397► Subscribe
China105085592► Subscribe
EcuadorSP13012790► 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
4 5029-2014Slovakia► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
/2014Austria► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
C0082France► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462/01Switzerland► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
90066-6Sweden► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
0704Netherlands► 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
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 leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
McKinsey
Merck
Colorcon
Harvard Business School
Healthtrust
Accenture
Cipla
Cantor Fitzgerald

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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