SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR - Generic Drug Details

What are the generic sources for sofosbuvir; velpatasvir; voxilaprevir and what is the scope of patent protection?

Sofosbuvir; velpatasvir; voxilaprevir is the generic ingredient in one branded drug marketed by Gilead Sciences Inc and is included in one NDA. There are nineteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir; velpatasvir; voxilaprevir has six hundred and twenty-two patent family members in forty-nine countries.

One supplier is listed for this compound.

Summary for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

International Patents:	622
US Patents:	19
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	18
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR
DailyMed Link:	SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Helwan University	Phase 4
Kirby Institute	Phase 4

See all SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR clinical trials

Pharmacology for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Drug Class	Hepatitis C Virus NS3/4A Protease Inhibitor Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors HCV NS3/4A Protease Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Anion Transporting Polypeptide 2B1 Inhibitors P-Glycoprotein Inhibitors RNA Replicase Inhibitors

US Patents and Regulatory Information for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

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

International Patents for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Country	Patent Number	Title	Estimated Expiration
South Korea	20180026563	항바이러스 화합물 (ANTIVIRAL COMPOUNDS)
New Zealand	596635	N-[(2’r)-2’-deoxy-2’-fluoro-2’-methyl-p-phenyl-5’-uridylyl]-l-alanine 1-methylethyl ester and process for its production
Australia	2010249481	N- [ (2 ' R) -2 ' -deoxy-2 ' -fluoro-2 ' -methyl-p-phenyl-5 ' -uridylyl] -L-alanine 1-methylethyl ester and process for its production
Israel	263155	פורמולציה משולבת של שלוש תרכובות אנטי-ויראליות (Combination formulation of three antiviral compounds)

Supplementary Protection Certificates for SOFOSBUVIR; VELPATASVIR; VOXILAPREVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	92600	Luxembourg		PRODUCT NAME: SOVALDI (SOFOSBUVIR); AUTHORISATION NUMBER AND DATE: EU/1/13/894(001-002) - SOVALDI - SOFOSBUVIR 20140117
2203462	214 5029-2014	Slovakia		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117