BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information
➤ Start Trial

or, See Plans & Pricing

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

Serving leading biopharmaceutical companies globally:

Federal Trade Commission
Cerilliant
Johnson and Johnson
Express Scripts
Baxter
Citi
Covington
Queensland Health
Medtronic
AstraZeneca

Generated: January 17, 2018

DrugPatentWatch Database Preview

SOVALDI Drug Profile

« Back to Dashboard

Which patents cover Sovaldi, and when can generic versions of Sovaldi launch?

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are nine patents protecting this drug.

This drug has two hundred and eighty-three patent family members in forty-five countries.

The generic ingredient in SOVALDI is sofosbuvir. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.
Summary for SOVALDI
Drug patent expirations by year for SOVALDI
Pharmacology for SOVALDI
Medical Subject Heading (MeSH) Categories for SOVALDI

US Patents and Regulatory Information for SOVALDI

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 ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 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 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
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 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 Y ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 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 Y ➤ Subscribe
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for SOVALDI

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
9,637,512 Nucleoside phosphoramidates ➤ Subscribe
8,735,372 Nucleoside phosphoramidate prodrugs ➤ Subscribe
8,642,756 Nucleoside phosphoramidates ➤ Subscribe
8,629,263 Nucleoside phosphoramidates ➤ Subscribe
8,563,530 Purine nucleoside phosphoramidate ➤ Subscribe
8,735,569 Nucleoside phosphoramidates ➤ Subscribe
9,393,256 Methods for treating HCV ➤ Subscribe
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Subscribe
9,585,906 Nucleoside phosphoramidate prodrugs ➤ Subscribe
8,859,756 Stereoselective synthesis of phosphorus containing actives ➤ Subscribe
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

International Patents for SOVALDI

Supplementary Protection Certificates for SOVALDI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
4 5029-2014 Slovakia ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2014000108 Germany ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2014040,C2203462 Lithuania ➤ Subscribe PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
14/065 Ireland ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
C0082 France ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
0704 Netherlands ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
/2014 Austria ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2014 00061 Denmark ➤ Subscribe PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
00704 Netherlands ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
600 Luxembourg ➤ Subscribe PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

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

Serving leading biopharmaceutical companies globally:

Accenture
Mallinckrodt
Dow
Baxter
Fish and Richardson
Harvard Business School
Daiichi Sankyo
Fuji
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.

botpot