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BioPharmaceutical Business Intelligence

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  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Accenture
Teva
UBS
Harvard Business School
Farmers Insurance
Fish and Richardson
Merck
Daiichi Sankyo
US Department of Justice

Generated: November 21, 2017

DrugPatentWatch Database Preview

HARVONI Drug Profile

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What is the patent landscape for Harvoni, and what generic Harvoni alternatives are available?

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

This drug has three hundred and sixty-nine patent family members in forty-five countries and twenty-two supplementary protection certificates in twelve countries.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. One supplier is listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.
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► 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► SubscribeY ► 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
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
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Non-Orange Book Patents for Tradename: HARVONI

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
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
9,637,512Nucleoside phosphoramidates► Subscribe
8,575,118Antiviral compounds► Subscribe
8,669,234Antiviral compounds► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
9,549,941Compositions and methods for treating hepatitis C virus► Subscribe
8,735,569Nucleoside phosphoramidates► Subscribe
9,585,906Nucleoside phosphoramidate prodrugs► Subscribe
8,859,756Stereoselective synthesis of phosphorus containing actives► 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: HARVONI

Country Document Number Estimated Expiration
Eurasian Patent Organization201370186► Subscribe
European Patent Office2824109► Subscribe
China105085592► Subscribe
Moldova, Republic of20140058► Subscribe
Spain2548156► Subscribe
South Korea101603817► Subscribe
San MarinoT201500284► Subscribe
Argentina089578► Subscribe
Japan5885659► Subscribe
China104211713► 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: HARVONI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000009Germany► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
4 5029-2014Slovakia► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
C0082France► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2 5001-2016Slovakia► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118
2014 00061Denmark► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
0704Netherlands► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2016002Lithuania► SubscribePRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141118
C0005France► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 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:

Merck
Chinese Patent Office
Farmers Insurance
AstraZeneca
Harvard Business School
Healthtrust
Citi
Fuji
Mallinckrodt
Argus 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.

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