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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
US Department of Justice
Merck
Daiichi Sankyo
Covington
Chinese Patent Office
US Army
Fish and Richardson
Cipla

Generated: February 21, 2018

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 seventy-four patent family members in forty-five countries.

The generic ingredient in EPCLUSA is sofosbuvir; velpatasvir. There are nine 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 for EPCLUSA

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;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,563,530 Purine nucleoside phosphoramidate ➤ Sign Up
8,859,756 Stereoselective synthesis of phosphorus containing actives ➤ Sign Up
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Sign Up
9,221,833 Antiviral compounds ➤ Sign Up
9,206,217 Nucleoside phosphoramidates ➤ Sign Up
9,051,340 Antiviral compounds ➤ Sign Up
9,809,600 Antiviral compounds ➤ Sign Up
9,156,823 Antiviral compounds ➤ Sign Up
9,393,256 Methods for treating HCV ➤ Sign Up
8,642,756 Nucleoside phosphoramidates ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for EPCLUSA

Supplementary Protection Certificates for EPCLUSA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00061 Denmark ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2014040 Lithuania ➤ Sign Up PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0140035 00135 Estonia ➤ Sign Up PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
C0082 France ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
00704 Netherlands ➤ Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
90066-6 Sweden ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
/2014 Austria ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
14/065 Ireland ➤ Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2014000108 Germany ➤ Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
0704 Netherlands ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Argus Health
Citi
Healthtrust
Cipla
Moodys
US Department of Justice
Baxter

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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