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Last Updated: August 14, 2020

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 two NDAs. There are seventeen patents protecting this drug.

This drug has five hundred and seventeen patent family members in forty-seven countries.

The generic ingredient in HARVONI is ledipasvir; sofosbuvir. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ledipasvir; sofosbuvir profile page.

US ANDA Litigation and Generic Entry Outlook for Harvoni

Harvoni was eligible for patent challenges on October 10, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14, 2032. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for HARVONI
Drug Prices for HARVONI

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Drug Sales Revenue Trends for HARVONI

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Generic Entry Opportunity Date for HARVONI
Generic Entry Dates for HARVONI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
PELLETS;ORAL
Generic Entry Dates 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.

Recent Clinical Trials for HARVONI

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Cairo UniversityPhase 2/Phase 3
University of MarylandEarly Phase 1
KlinEra Global ServicesPhase 2

See all HARVONI clinical trials

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   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir PELLETS;ORAL 212477-002 Aug 28, 2019 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-001 Oct 10, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
Gilead Sciences Inc HARVONI ledipasvir; sofosbuvir TABLET;ORAL 205834-002 Aug 28, 2019 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for HARVONI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2430014 PA2016002,C2430014 Lithuania   Start Trial PRODUCT NAME: LEDIPASVIRAS; REGISTRATION NO/DATE: EU/1/14/958(001-002) 20141117
2203462 2014029 Norway   Start Trial PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2430014 16C0005 France   Start Trial PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2203462 CA 2014 00061 Denmark   Start Trial PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462 122014000108 Germany   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2430014 CA 2016 00006 Denmark   Start Trial PRODUCT NAME: LEDISPAVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2430014 SPC/GB16/008 United Kingdom   Start Trial PRODUCT NAME: LEDIPASVIR; REGISTERED: UK EU/1/14/958(001-002) 20141118
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
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Boehringer Ingelheim
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Harvard Business School
Johnson and Johnson

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 verification 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.