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Last Updated: December 13, 2019

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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 sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ledipasvir; sofosbuvir has four hundred and ninety-nine 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:	499
US Patents:	16
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	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	205834-001	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	205834-002	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
>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
European Patent Office	2950786	Start Trial
World Intellectual Property Organization (WIPO)	2011123668	Start Trial
Brazil	122014013631	Start Trial
Ukraine	108610	Start Trial
South Korea	20140108645	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
2203462	PA2014040,C2203462	Lithuania	Start Trial	PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	CR 2014 00061	Denmark	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462	C20140035 00135	Estonia	Start Trial	PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2430014	92956	Luxembourg	Start Trial	PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 - HARVONI (LEDIPASVIR-SOFOSBUVIR) 20141118
2203462	CA 2014 00061	Denmark	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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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 verifification 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.

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