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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Harvard Business School
Daiichi Sankyo
QuintilesIMS
UBS
Fish and Richardson
Johnson and Johnson
Cipla
Moodys

Generated: June 25, 2018

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 four hundred and three patent family members in forty-five countries.

One supplier is listed for this compound.
Summary for ledipasvir; sofosbuvir

US Patents and Regulatory Information for ledipasvir; 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 HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,575,118 Antiviral compounds ➤ Sign Up
8,669,234 Antiviral compounds ➤ Sign Up
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Sign Up
8,957,046 Nucleoside phosphoramidate prodrugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for ledipasvir; sofosbuvir

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2 5001-2016 Slovakia ➤ Sign Up PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141118
2203462/01 Switzerland ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
16/002 Ireland ➤ Sign Up PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
90002-9 Sweden ➤ Sign Up PRODUCT NAME: ; REG. NO/DATE: EU/1/14/958 20141118
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Colorcon
Federal Trade Commission
Cantor Fitzgerald
Boehringer Ingelheim
Johnson and Johnson
Cerilliant
Deloitte
Fuji

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.