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Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

What are the generic drug 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.

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

Summary for sofosbuvir; velpatasvir; voxilaprevir

US Patents:	15
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	9
Suppliers / Packagers:	1
Clinical Trials:	7
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
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

International Patents for sofosbuvir; velpatasvir; voxilaprevir

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Country	Document Number	Estimated Expiration
Spain	2644990	➤ Sign Up
Spain	2516466	➤ Sign Up
European Patent Office	2870160	➤ Sign Up
Japan	2015024998	➤ Sign Up
Hong Kong	1213572	➤ Sign Up
New Zealand	623602	➤ 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
C0082	France	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2014040	Lithuania	➤ Sign Up	PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
0704	Netherlands	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
600	Luxembourg	➤ Sign Up	PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
90066-6	Sweden	➤ Sign Up	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2014040,C2203462	Lithuania	➤ Sign Up	PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description