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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Farmers Insurance
McKesson
Citi
Queensland Health
McKinsey
Fuji
Fish and Richardson
Federal Trade Commission

Generated: April 24, 2018

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 two branded drugs marketed by Gilead Sciences Inc and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

There are nine drug master file entries for sofosbuvir; velpatasvir. One supplier is listed for this compound.
Summary for sofosbuvir; velpatasvir
International Patents:384
US Patents:16
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: 9
Suppliers / Packagers: 1
Clinical Trials: 228
Drug Prices:see low prices
DailyMed Link:sofosbuvir; velpatasvir at DailyMed

US Patents and Regulatory Information for sofosbuvir; velpatasvir

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 Y ➤ Sign Up
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 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 Y Y ➤ 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 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
8,957,046 Nucleoside phosphoramidate prodrugs ➤ Sign Up
9,868,745 Antiviral compounds ➤ Sign Up
9,051,340 Antiviral compounds ➤ Sign Up
9,156,823 Antiviral compounds ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for sofosbuvir; velpatasvir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2014 Austria ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
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
600 Luxembourg ➤ Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2014040,C2203462 Lithuania ➤ Sign Up PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Cantor Fitzgerald
Boehringer Ingelheim
Medtronic
Chubb
Fish and Richardson
Cipla
Healthtrust
Queensland Health

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.