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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Farmers Insurance
US Army
Moodys
McKinsey
QuintilesIMS
Cipla
Fuji
Chubb

Generated: April 26, 2018

DrugPatentWatch Database Preview

HARVONI Drug Profile

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When do Harvoni patents expire, and what generic 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 four hundred and three 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.

US Patents and Regulatory Information for HARVONI

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 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
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 ➤ 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 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
9,585,906 Nucleoside phosphoramidate prodrugs ➤ Sign Up
8,629,263 Nucleoside phosphoramidates ➤ Sign Up
8,575,118 Antiviral compounds ➤ Sign Up
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for HARVONI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016002,C2430014 Lithuania ➤ Sign Up PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
2203462/01 Switzerland ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
0704 Netherlands ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2014 00061 Denmark ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Merck
US Department of Justice
AstraZeneca
QuintilesIMS
Cantor Fitzgerald
Express Scripts
Colorcon
Chubb

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