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Serving leading biopharmaceutical companies globally:

Chubb
Novartis
Deloitte
Julphar
Cipla
Johnson and Johnson
Covington
Federal Trade Commission
Moodys
Argus Health

Generated: January 16, 2018

DrugPatentWatch Database Preview

Sofosbuvir - Generic Drug Details

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What are the generic sources for sofosbuvir and what is the scope of sofosbuvir patent protection?

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

Sofosbuvir has two hundred and eighty-three patent family members in forty-five countries and fourteen supplementary protection certificates in twelve countries.

There are six drug master file entries for sofosbuvir. One supplier is listed for this compound.
Summary for sofosbuvir
Pharmacology for sofosbuvir
Medical Subject Heading (MeSH) Categories for sofosbuvir

US Patents and Regulatory Information for sofosbuvir

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 SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
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

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
8,735,569 Nucleoside phosphoramidates ➤ Subscribe
8,957,046 Nucleoside phosphoramidate prodrugs ➤ Subscribe
9,393,256 Methods for treating HCV ➤ Subscribe
9,637,512 Nucleoside phosphoramidates ➤ Subscribe
9,585,906 Nucleoside phosphoramidate prodrugs ➤ Subscribe
8,563,530 Purine nucleoside phosphoramidate ➤ Subscribe
8,859,756 Stereoselective synthesis of phosphorus containing actives ➤ Subscribe
8,642,756 Nucleoside phosphoramidates ➤ Subscribe
8,629,263 Nucleoside phosphoramidates ➤ Subscribe
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for sofosbuvir

Supplementary Protection Certificates for sofosbuvir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0082 France ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
14/065 Ireland ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2014040 Lithuania ➤ Subscribe PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0704 Netherlands ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
90066-6 Sweden ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
00704 Netherlands ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
0140035 00135 Estonia ➤ Subscribe PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2014040,C2203462 Lithuania ➤ Subscribe PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2014 00061 Denmark ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
600 Luxembourg ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
UBS
Merck
McKinsey
AstraZeneca
Harvard Business School
Teva
Express Scripts
US Army

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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