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Serving leading biopharmaceutical companies globally:

Merck
Baxter
UBS
Cipla
Fish and Richardson
McKesson
Medtronic
Johnson and Johnson
AstraZeneca
McKinsey

Generated: October 20, 2017

DrugPatentWatch Database Preview

Ledipasvir; sofosbuvir - Generic Drug Details

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

Ledipasvir; sofosbuvir
is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has three hundred and seventy patent family members in forty-five countries and twenty-two supplementary protection certificates in twelve countries.

One supplier is listed for this compound.

Summary for Generic Name: ledipasvir; sofosbuvir

US Patents:15
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list225
Drug Prices:see low prices
DailyMed Link:ledipasvir; sofosbuvir at DailyMed
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
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► Subscribe ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ledipasvir; 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
9,585,906Nucleoside phosphoramidate prodrugs► Subscribe
9,637,512Nucleoside phosphoramidates► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,575,118Antiviral compounds► Subscribe
8,735,569Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
9,549,941Compositions and methods for treating hepatitis C virus► Subscribe
8,629,263Nucleoside 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 Ingredient: ledipasvir; sofosbuvir

Country Document Number Estimated Expiration
Mexico2012011324► Subscribe
Singapore184324► Subscribe
Israel216254► Subscribe
San MarinoT201600316► Subscribe
Argentina088580► Subscribe
Denmark2203462► Subscribe
European Patent Office2430014► Subscribe
Chile2014001397► Subscribe
Hong Kong1207638► Subscribe
Argentina082937► 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.

Export unavailable in trial.
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Supplementary Protection Certificates for Tradename: LEDIPASVIR; SOFOSBUVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0005France► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
/2014Austria► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2016002Lithuania► SubscribePRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141118
4 5029-2014Slovakia► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION 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
2203462/01Switzerland► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2016002,C2430014Lithuania► SubscribePRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
0796Netherlands► SubscribePRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Fuji
Cerilliant
Deloitte
Novartis
Chinese Patent Office
UBS
Queensland Health
Covington
Boehringer Ingelheim
McKinsey

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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