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Serving leading biopharmaceutical companies globally:

Moodys
Healthtrust
Daiichi Sankyo
Citi
Boehringer Ingelheim
AstraZeneca
Harvard Business School
Federal Trade Commission
Fuji
Medtronic

Generated: October 22, 2017

DrugPatentWatch Database Preview

SOVALDI Drug Profile

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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 seventy-six patent family members in forty-five countries and fourteen supplementary protection certificates in twelve 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 Tradename: SOVALDI

US Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list20
Clinical Trials: see list22
Patent Applications: see list88
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SOVALDI at DailyMed

Pharmacology for Tradename: 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;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,563,530Purine nucleoside phosphoramidate► Subscribe
9,637,512Nucleoside phosphoramidates► Subscribe
8,735,372Nucleoside phosphoramidate prodrugs► Subscribe
9,393,256Methods for treating HCV► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
8,957,046Nucleoside phosphoramidate prodrugs► Subscribe
8,735,569Nucleoside phosphoramidates► 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: SOVALDI

Country Document Number Estimated Expiration
Israel222810► Subscribe
European Patent Office2785340► Subscribe
Eurasian Patent Organization201290993► Subscribe
Costa Rica20120532► Subscribe
EcuadorSP12012282► Subscribe
Israel237471► Subscribe
Japan2014532657► Subscribe
European Patent Office2552933► Subscribe
Brazil112012024884► Subscribe
European Patent Office2432792► 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: SOVALDI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0704Netherlands► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
90066-6Sweden► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
/2014Austria► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2014040Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
14/065Ireland► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Julphar
Baxter
Citi
Argus Health
US Department of Justice
Cerilliant
Accenture
Teva
Novartis
Johnson and Johnson

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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