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

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

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

Summary for sofosbuvir; velpatasvir

International Patents:	468
US Patents:	25
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	9
Suppliers / Packagers:	1
Clinical Trials:	58
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

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

Sponsor	Phase
Catherine Chappell	Phase 1
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 1
Icahn School of Medicine at Mount Sinai	Phase 4

See all sofosbuvir; velpatasvir clinical trials

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

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	Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No			Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y

International Patents for sofosbuvir; velpatasvir

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013040492
World Intellectual Property Organization (WIPO)	2010135569
New Zealand	709926
Philippines	12014501133
European Patent Office	2552930

Supplementary Protection Certificates for sofosbuvir; velpatasvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	122014000108	Germany		PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462	214 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116