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Last Updated: October 19, 2019

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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 two NDAs. There are sixteen patents protecting this drug.

This drug has four hundred and ninety-two 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.

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 Date for HARVONI*:
Constraining patent/regulatory exclusivity:
PEDIATRIC 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
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-12-26
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.2017-12-06
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.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 PELLETS;ORAL 212477-001 Aug 28, 2019 RX Yes No   Start Trial   Start Trial   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 205834-001 Oct 10, 2014 RX Yes Yes   Start Trial   Start Trial   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
>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 122016000009 Germany   Start Trial PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958 20141117
2203462 C02203462/01 Switzerland   Start Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2430014 1690002-9 Sweden   Start Trial PRODUCT NAME: ; REG. NO/DATE: EU/1/14/958 20141118
2203462 C300704 Netherlands   Start Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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