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Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

What are the generic sources for sofosbuvir; velpatasvir; voxilaprevir and what is the scope of sofosbuvir; velpatasvir; voxilaprevir 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 four hundred and fifteen patent family members in forty-six 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:	415
US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Clinical Trials:	228
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir; velpatasvir; voxilaprevir
DailyMed Link:	sofosbuvir; velpatasvir; voxilaprevir at DailyMed

Pharmacology for sofosbuvir; velpatasvir; voxilaprevir

Ingredient-type	Nucleoside Analog
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 Breast Cancer Resistance Protein Inhibitors P-Glycoprotein Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors HCV NS3/4A Protease Inhibitors

US Patents and Regulatory Information for sofosbuvir; velpatasvir; voxilaprevir

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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	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	➤ Sign Up	➤ Sign Up	Y	Y		➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

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Non-Orange Book US Patents for sofosbuvir; velpatasvir; voxilaprevir

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.

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Patent No.	Title	Estimated Patent Expiration
8,563,530	Purine nucleoside phosphoramidate	➤ Sign Up
9,221,833	Antiviral compounds	➤ Sign Up
9,637,512	Nucleoside phosphoramidates	➤ Sign Up
8,906,880	Nucleoside phosphoramidate prodrugs	➤ Sign Up
Patent No.	Title	Estimated Patent Expiration

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International Patents for sofosbuvir; velpatasvir; voxilaprevir

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Country	Document Number	Estimated Expiration
Hungary	S1400059	➤ Sign Up
South Korea	20130064064	➤ Sign Up
China	104039319	➤ Sign Up
New Zealand	720391	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2014 00061	Denmark	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
0704	Netherlands	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
90066-6	Sweden	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2203462/01	Switzerland	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description