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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 seventeen patents protecting this drug.

This drug has four hundred and ninety-eight 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^th, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 14^th, 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.

Summary for HARVONI

International Patents:	498
US Patents:	17
Applicants:	1
NDAs:	2
Suppliers / Packagers:	2
Bulk Api Vendors:	1
Clinical Trials:	35
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HARVONI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HARVONI
DailyMed Link:	HARVONI at DailyMed

See drug prices for HARVONI

See drug sales revenues for HARVONI

Generic Entry Opportunity Date for HARVONI

NDA:

212477

Dosage:

PELLETS;ORAL

NDA:

205834

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

Sponsor	Phase
University of Maryland	Early Phase 1
KlinEra Global Services	Phase 2
Tanta University	Phase 4

See all HARVONI clinical trials

Recent Litigation for HARVONI

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.	2018-03-27
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED	2018-03-14
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.	2014-07-01

See all HARVONI litigation

PTAB Litigation

Petitioner	Date
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

Pharmacology for HARVONI

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	P-Glycoprotein Inhibitors Breast Cancer Resistance Protein Inhibitors RNA Replicase Inhibitors

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					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	PELLETS;ORAL	212477-002	Aug 28, 2019		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-001	Oct 10, 2014		RX	Yes	Yes					Y
Gilead Sciences Inc	HARVONI	ledipasvir; sofosbuvir	TABLET;ORAL	205834-002	Aug 28, 2019		RX	Yes	No					Y

International Patents for HARVONI

Country	Patent Number	Estimated Expiration
Moldova, Republic of	4430
Colombia	6930366
Japan	2014532657
African Regional IP Organization (ARIPO)	3622
Taiwan	201318627
Chile	2011000718

Supplementary Protection Certificates for HARVONI

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2430014	2016004	Norway		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958 20141203
2430014	CR 2016 00006	Denmark		PRODUCT NAME: LEDIPASVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2203462	300704	Netherlands		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014	300796	Netherlands		PRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118