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Last Updated: December 9, 2019

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Sofosbuvir; velpatasvir - Generic Drug Details

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What are the generic drug sources for sofosbuvir; velpatasvir and what is the scope of freedom to operate?

Sofosbuvir; velpatasvir is the generic ingredient in two branded drugs 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.

Sofosbuvir; velpatasvir has four hundred and fifty-two patent family members in forty-seven countries.

There are nine drug master file entries for sofosbuvir; velpatasvir. Two suppliers are listed for this compound.

Summary for sofosbuvir; velpatasvir

International Patents:	452
US Patents:	17
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	9
Suppliers / Packagers:	2
Clinical Trials:	56
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir
DailyMed Link:	sofosbuvir; velpatasvir at DailyMed

Recent Clinical Trials for sofosbuvir; velpatasvir

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Sponsor	Phase
National Cancer Institute (NCI)	Phase 4
University of Kentucky	Phase 4
National Institute on Drug Abuse (NIDA)	Phase 4

See all sofosbuvir; velpatasvir clinical trials

Recent Litigation for sofosbuvir; velpatasvir

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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 sofosbuvir; velpatasvir litigation

PTAB Litigation

Petitioner	Date
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-12-26
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-11-09
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-11-02

See all sofosbuvir; velpatasvir litigation

Pharmacology for sofosbuvir; velpatasvir

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for sofosbuvir; velpatasvir

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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	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	Start Trial	Start Trial	Y	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 sofosbuvir; velpatasvir

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Country	Patent Number	Estimated Expiration
Peru	01832013	Start Trial
Chile	2014000630	Start Trial
Lithuania	2432792	Start Trial
Argentina	080819	Start Trial
Mexico	2012011324	Start Trial
Canada	2840242	Start Trial
San Marino	T201500197	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	92600	Luxembourg	Start Trial	PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2203462	67/2014	Austria	Start Trial	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035 00135	Estonia	Start Trial	PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	C300704	Netherlands	Start Trial	PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	CA 2014 00061	Denmark	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
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	300704	Netherlands	Start Trial	PRODUCT NAME: 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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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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