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Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

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

Sofosbuvir; velpatasvir; voxilaprevir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir; voxilaprevir has five hundred and forty-three patent family members in forty-eight countries.

There are nine drug master file entries for sofosbuvir; velpatasvir; voxilaprevir. One supplier is listed for this compound.

Summary for sofosbuvir; velpatasvir; voxilaprevir

International Patents:	543
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Clinical Trials:	12
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir; voxilaprevir
DailyMed Link:	sofosbuvir; velpatasvir; voxilaprevir at DailyMed

Recent Clinical Trials for sofosbuvir; velpatasvir; voxilaprevir

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Helwan University	Phase 4
Partners in Health	Phase 4
Kirby Institute	Phase 4

See all sofosbuvir; velpatasvir; voxilaprevir clinical trials

Pharmacology for sofosbuvir; velpatasvir; voxilaprevir

Drug Class	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus NS3/4A Protease Inhibitor
Mechanism of Action	RNA Replicase Inhibitors 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 HCV NS3/4A Protease Inhibitors

US Patents and Regulatory Information for sofosbuvir; velpatasvir; voxilaprevir

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					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y

International Patents for sofosbuvir; velpatasvir; voxilaprevir

Country	Patent Number	Estimated Expiration
Costa Rica	20120532
Mexico	336580
Japan	2010532747

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
2203462	C 2014 043	Romania		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014