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VOSEVI Drug Profile

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Which patents cover Vosevi, and what generic alternatives are available?

Vosevi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are fifteen patents protecting this drug.

This drug has four hundred and fifteen patent family members in forty-six countries.

The generic ingredient in VOSEVI is sofosbuvir; velpatasvir; voxilaprevir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir; velpatasvir; voxilaprevir profile page.

Summary for VOSEVI

International Patents:	415
US Patents:	15
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	1
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOSEVI
DailyMed Link:	VOSEVI at DailyMed

US Patents and Regulatory Information for VOSEVI

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

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Non-Orange Book US Patents for VOSEVI

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,859,756	Stereoselective synthesis of phosphorus containing actives
9,655,944	Inhibitors of hepatitis C virus
9,156,823	Antiviral compounds
9,221,833	Antiviral compounds

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International Patents for VOSEVI

Country	Document Number	Estimated Expiration
Singapore	179445
Argentina	081813
Israel	244123
Mexico	2013005575

Supplementary Protection Certificates for VOSEVI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
4 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
0140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014