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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Express Scripts
McKesson
Cantor Fitzgerald
Chubb
Fuji
US Army
Chinese Patent Office

Generated: November 20, 2018

DrugPatentWatch Database Preview

HARVONI Drug Profile

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Which patents cover Harvoni, and what generic alternatives are available?

Harvoni is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are sixteen patents protecting this drug.

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.

Drug patent expirations by year for HARVONI
Generic Entry Opportunity Date for HARVONI
Generic Entry Date for HARVONI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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 ➤ 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
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
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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Supplementary Protection Certificates for HARVONI

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
16/002 Ireland ➤ Sign Up PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2016 00006 Denmark ➤ Sign Up PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2014 00061 Denmark ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2016002,C2430014 Lithuania ➤ Sign Up PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
C0005 France ➤ Sign Up PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
QuintilesIMS
Express Scripts
McKesson
Cantor Fitzgerald
Chubb
Fuji
US Army
Chinese Patent Office

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.