.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Drug patents in 130+ countries

► See Plans & Pricing

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

Serving 500+ biopharmaceutical companies globally:

Accenture
Boehringer Ingelheim
Cantor Fitzgerald
Healthtrust
Express Scripts
Baxter
Johnson and Johnson
US Department of Justice
Cerilliant
Chinese Patent Office

Generated: September 22, 2017

DrugPatentWatch Database Preview

HARVONI Drug Profile

« Back to Dashboard

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 forty-six patent family members in forty-five 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.

Summary for Tradename: HARVONI

Patents:15
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list31
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:HARVONI 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► 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► 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► 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► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,859,756Stereoselective synthesis of phosphorus containing actives► Subscribe
8,642,756Nucleoside phosphoramidates► Subscribe
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
8,669,234Antiviral compounds► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
8,575,118Antiviral compounds► Subscribe
9,585,906Nucleoside phosphoramidate prodrugs► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
8,735,569Nucleoside phosphoramidates► Subscribe
8,957,046Nucleoside phosphoramidate prodrugs► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: HARVONI

Country Document Number Estimated Expiration
Brazil112014010295► Subscribe
Mexico2009010401► Subscribe
CroatiaP20140667► Subscribe
World Intellectual Property Organization (WIPO)2011123645► Subscribe
CroatiaP20160958► Subscribe
BrazilPI0823519► Subscribe
Eurasian Patent Organization027493► Subscribe
Norway2016004► Subscribe
Israel222810► Subscribe
Israel233679► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: HARVONI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90066-6Sweden► SubscribePRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
C0005France► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
4 5029-2014Slovakia► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
0796Netherlands► SubscribePRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118
2014000108Germany► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
14/065Ireland► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2016000009Germany► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
00704Netherlands► SubscribePRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

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

Serving 500+ biopharmaceutical companies globally:

Citi
Fish and Richardson
Deloitte
McKesson
Johnson and Johnson
McKinsey
Cipla
Chubb
Chinese Patent Office
Farmers Insurance

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted Heap | Mobile and Web Analytics
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot