Sofosbuvir; velpatasvir; voxilaprevir - Generic Drug Details

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What are the generic sources for sofosbuvir; velpatasvir; voxilaprevir and what is the scope of 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 eighteen 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:	18
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

Generic Entry Date for sofosbuvir; velpatasvir; voxilaprevir^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

Anatomical Therapeutic Chemical (ATC) Classes for sofosbuvir; velpatasvir; voxilaprevir

J05AP	Antivirals for treatment of HCV infections
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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	⤷ Sign Up
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			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	⤷ 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	Patent Number	Title	Estimated Expiration
South Korea	20140108645	COMPOSITIONS AND METHODS FOR TREATING HEPATITIS C VIRUS	⤷ Sign Up
Ecuador	SP13012790	IMIDAZOLILIMIDAZOLES CONDENSADOS COMO COMPUESTOS ANTIVIRALES	⤷ Sign Up
Japan	6377781		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sofosbuvir; velpatasvir; voxilaprevir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	67/2014	Austria	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	2014/065	Ireland	⤷ Sign Up	PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	C20140035 00135	Estonia	⤷ Sign Up	PRODUCT NAME: SOFOSBUVIIR
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.