DrugPatentWatch Database Preview

Sofosbuvir - Generic Drug Details

« Back to Dashboard

What are the generic sources for sofosbuvir and what is the scope of freedom to operate?

Sofosbuvir is the generic ingredient in three branded drugs marketed by Gilead Sciences Inc and is included in four NDAs. There are twenty-six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and forty-one patent family members in forty-seven countries.

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

Summary for sofosbuvir

International Patents:	341
US Patents:	26
Tradenames:	3
Applicants:	1
NDAs:	4
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	79
Clinical Trials:	299
Patent Applications:	1,147
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir
DailyMed Link:	sofosbuvir at DailyMed

Recent Clinical Trials for sofosbuvir

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

Sponsor	Phase
University of Witwatersrand, South Africa	Phase 2
Mansoura University	Phase 3
Pontificia Universidad Javeriana	Phase 2/Phase 3

See all sofosbuvir clinical trials

Pharmacology for sofosbuvir

Drug Class	Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	RNA Replicase Inhibitors

Medical Subject Heading (MeSH) Categories for sofosbuvir

Antiviral Agents

Paragraph IV (Patent) Challenges for SOFOSBUVIR

Tradename	Dosage	Ingredient	NDA	Submissiondate
SOVALDI	TABLET;ORAL	sofosbuvir	204671	2017-12-06

US Patents and Regulatory Information for sofosbuvir

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	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No					Y
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes			Y	Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes			Y

International Patents for sofosbuvir

Country	Patent Number	Estimated Expiration
Australia	2010249481
Cyprus	1118045
Argentina	088580
Japan	2014532657
Hong Kong	1206033
Taiwan	200904453
Japan	6058528

Supplementary Protection Certificates for sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	C02203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014	92956	Luxembourg		PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 - HARVONI (LEDIPASVIR-SOFOSBUVIR) 20141118
2203462	C300704	Netherlands		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	1490066-6	Sweden		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2203462	67/2014	Austria		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462	C20140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014