You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Boehringer Ingelheim
McKesson
Harvard Business School
Johnson and Johnson

Last Updated: April 5, 2020

DrugPatentWatch Database Preview

HARVONI Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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 five 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. Two suppliers are 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

< Available with Subscription >

  Start Trial

Drug patent expirations by year for HARVONI
Drug Prices for HARVONI

See drug prices for HARVONI

Drug Sales Revenue Trends for HARVONI

See drug sales revenues for HARVONI

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
University of MarylandEarly Phase 1
KlinEra Global ServicesPhase 2
Tanta UniversityPhase 4

See all HARVONI clinical trials

Recent Litigation for HARVONI

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.2018-03-27
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED2018-03-14
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.2014-07-01

See all HARVONI litigation

PTAB Litigation
PetitionerDate
2017-12-26
2017-12-06
2017-11-09

See all HARVONI litigation

Synonyms for HARVONI
Ledipasvir / sofosbuvir
Ledipasvir and sofosbuvir
Ledipasvir mixture with sofosbuvir
S900006370
Sofosbuvir / Ledipasvir
Sofosbuvir and Ledipasvir
Sofosbuvir/Ledipasvir

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
>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
2203462 PA2014040,C2203462 Lithuania   Start Trial PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014 2016004 Norway   Start Trial PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
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
2203462 C20140035 00135 Estonia   Start Trial PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Moodys
Boehringer Ingelheim
McKesson
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.