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Last Updated: February 16, 2020

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Ledipasvir; sofosbuvir - Generic Drug Details

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What are the generic sources for ledipasvir; sofosbuvir and what is the scope of patent protection?

Ledipasvir; sofosbuvir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has four hundred and ninety-eight patent family members in forty-seven countries.

There is one drug master file entry for ledipasvir; sofosbuvir. Two suppliers are listed for this compound.

Summary for ledipasvir; sofosbuvir

International Patents:	498
US Patents:	17
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	1
Suppliers / Packagers:	2
Clinical Trials:	90
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ledipasvir; sofosbuvir
DailyMed Link:	ledipasvir; sofosbuvir at DailyMed

Recent Clinical Trials for ledipasvir; sofosbuvir

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Sponsor	Phase
Cairo University	Phase 1/Phase 2
Ain Shams University	Phase 1/Phase 2
University of Maryland	Early Phase 1

See all ledipasvir; sofosbuvir clinical trials

Recent Litigation for ledipasvir; sofosbuvir

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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 ledipasvir; sofosbuvir 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 ledipasvir; sofosbuvir litigation

Pharmacology for ledipasvir; sofosbuvir

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

US Patents and Regulatory Information for ledipasvir; sofosbuvir

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Glossary

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

International Patents for ledipasvir; sofosbuvir

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Country	Patent Number	Estimated Expiration
San Marino	T201500284	Start Trial
Portugal	2432792	Start Trial
Peru	20120509	Start Trial
Eurasian Patent Organization	201370186	Start Trial
Israel	216254	Start Trial
Japan	2016053045	Start Trial
South Korea	101759369	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ledipasvir; sofosbuvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2430014	16C0005	France	Start Trial	PRODUCT NAME: LEDIPASVIR; REGISTRATION NO/DATE: EU/1/14/958/001-002 20141118
2203462	1490066-6	Sweden	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2430014	CA 2016 00006	Denmark	Start Trial	PRODUCT NAME: LEDISPAVIR; REG. NO/DATE: EU/1/14/958/001-002 20141118
2203462	2014/065	Ireland	Start Trial	PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2430014	300796	Netherlands	Start Trial	PRODUCT NAME: LEDIPASVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/958 20141118
2430014	C20160002 00186	Estonia	Start Trial	PRODUCT NAME: LEDIPASVIIR;REG NO/DATE: EU/1/14/958 18.11.2014
2430014	92956	Luxembourg	Start Trial	PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 - HARVONI (LEDIPASVIR-SOFOSBUVIR) 20141118
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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