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 ninety 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:	490
US Patents:	25
Tradenames:	2
Applicants:	1
NDAs:	2
Drug Master File Entries:	9
Suppliers / Packagers:	1
Clinical Trials:	61
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
Helwan University	Phase 4
Mansoura University	Phase 3
Cairo University	Phase 2/Phase 3

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

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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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	Start Trial	Start Trial				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	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				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
>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
Hong Kong	1213572	Start Trial
Denmark	2609923	Start Trial
Poland	2552930	Start Trial
Colombia	6791562	Start Trial
European Patent Office	2432792	Start Trial
World Intellectual Property Organization (WIPO)	2008121634	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	CR 2014 00061	Denmark	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117
2203462	C02203462/01	Switzerland	Start Trial	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	214 5029-2014	Slovakia	Start Trial	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	67/2014	Austria	Start Trial	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	PA2014040,C2203462	Lithuania	Start Trial	PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2635588	C02635588/01	Switzerland	Start Trial	PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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