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Serving leading biopharmaceutical companies globally:

Fuji
Fish and Richardson
Chinese Patent Office
Medtronic
Chubb
Mallinckrodt
US Department of Justice
Baxter
Cipla
Teva

Generated: November 20, 2017

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 seventy-seven 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.

Pharmacology for sofosbuvir

Medical Subject Heading (MeSH) Categories 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
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VOSEVI
sofosbuvir; velpatasvir; voxilaprevir
TABLET;ORAL209195-001Jul 18, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
EPCLUSA
sofosbuvir; velpatasvir
TABLET;ORAL208341-001Jun 28, 2016RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
SOVALDI
sofosbuvir
TABLET;ORAL204671-001Dec 6, 2013RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VOSEVI
sofosbuvir; velpatasvir; voxilaprevir
TABLET;ORAL209195-001Jul 18, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VOSEVI
sofosbuvir; velpatasvir; voxilaprevir
TABLET;ORAL209195-001Jul 18, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
VOSEVI
sofosbuvir; velpatasvir; voxilaprevir
TABLET;ORAL209195-001Jul 18, 2017RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,642,756Nucleoside phosphoramidates► Subscribe
9,393,256Methods for treating HCV► Subscribe
9,637,512Nucleoside phosphoramidates► Subscribe
8,957,046Nucleoside phosphoramidate prodrugs► Subscribe
9,585,906Nucleoside phosphoramidate prodrugs► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
8,735,569Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,563,530Purine nucleoside phosphoramidate► 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 Ingredient: sofosbuvir

Country Document Number Estimated Expiration
New Zealand623396► Subscribe
Denmark2552930► Subscribe
World Intellectual Property Organization (WIPO)2010135569► Subscribe
Argentina080870► Subscribe
Spain2492470► Subscribe
World Intellectual Property Organization (WIPO)2013040492► Subscribe
Moldova, Republic of20140058► Subscribe
Costa Rica20120532► Subscribe
Hong Kong1202268► Subscribe
Ukraine114097► 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: SOFOSBUVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90066-6Sweden► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2014040Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
600Luxembourg► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
14/065Ireland► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
0704Netherlands► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
C0082France► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Argus Health
Johnson and Johnson
McKesson
Cerilliant
Citi
Merck
Chubb
US Department of Justice
Mallinckrodt
Covington

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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