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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Baxter
US Army
Deloitte
Medtronic
Cantor Fitzgerald
Chinese Patent Office
McKinsey
Cipla

Generated: August 15, 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 ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial
8,669,234 Antiviral compounds ➤ Try a Free Trial
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Try a Free Trial
8,957,046 Nucleoside phosphoramidate prodrugs ➤ Try a Free Trial
9,585,906 Nucleoside phosphoramidate prodrugs ➤ Try a Free Trial
8,563,530 Purine nucleoside phosphoramidate ➤ Try a Free Trial
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
2016002,C2430014 Lithuania ➤ Try a Free Trial PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
C0005 France ➤ Try a Free Trial PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2014 00061 Denmark ➤ Try a Free Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2014000108 Germany ➤ Try a Free Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2016 00006 Denmark ➤ Try a Free Trial PRODUCT NAME: LEDISPAVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
0160002 00186 Estonia ➤ Try a Free Trial PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Medtronic
Dow
Cipla
Express Scripts
McKesson
Moodys
Cantor Fitzgerald
Accenture
Harvard Business School

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.