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

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Ledipasvir; sofosbuvir - Generic Drug Details

« Back to Dashboard

What are the generic drug sources, and freedom to operate, for ledipasvir; sofosbuvir?

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.

This ingredient has three hundred and ten patent family members in forty-three countries.

One supplier is listed for this compound.

Summary for Generic Name: ledipasvir; sofosbuvir

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packagers: see list1
Clinical Trials: see list163
Drug Prices:see low prices
DailyMed Link:ledipasvir; sofosbuvir at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes8,618,076► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes8,088,368► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes9,284,342► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes8,822,430► SubscribeYY ► Subscribe
Gilead Sciences Inc
HARVONI
ledipasvir; sofosbuvir
TABLET;ORAL205834-001Oct 10, 2014RXYesYes9,511,056► 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 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
8,906,880Nucleoside phosphoramidate prodrugs► Subscribe
9,206,217Nucleoside phosphoramidates► Subscribe
8,629,263Nucleoside phosphoramidates► Subscribe
8,957,046Nucleoside phosphoramidate prodrugs► Subscribe
9,549,941Compositions and methods for treating hepatitis C virus► 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 Ingredient: ledipasvir; sofosbuvir

Country Document Number Estimated Expiration
Uruguay32629► Subscribe
South Africa200906647► Subscribe
Hong Kong1202268► Subscribe
South Africa201108749► Subscribe
African Regional IP Organization (ARIPO)201206543► 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: LEDIPASVIR; SOFOSBUVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0140035 00135Estonia► SubscribePRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462/01Switzerland► SubscribePRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
C0005France► SubscribePRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2014040,C2203462Lithuania► SubscribePRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0704Netherlands► SubscribePRODUCT NAME: 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

How our clients use DrugPatentWatch

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.

`abc