SOFOSBUVIR; VELPATASVIR - Generic Drug Details

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

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

Sofosbuvir; velpatasvir has five hundred and nineteen patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for SOFOSBUVIR; VELPATASVIR

International Patents:	519
US Patents:	21
Tradenames:	2
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Clinical Trials:	73
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOFOSBUVIR; VELPATASVIR
DailyMed Link:	SOFOSBUVIR; VELPATASVIR at DailyMed

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

Dosage:

TABLET;ORAL

Dosage:

PELLETS;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

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
The University of Queensland	Phase 4
Cairns Hinterland Health Hospital and Health Services	Phase 4

See all SOFOSBUVIR; VELPATASVIR clinical trials

Pharmacology for SOFOSBUVIR; VELPATASVIR

Drug Class	Hepatitis C Virus NS5A Inhibitor Hepatitis C Virus Nucleotide Analog NS5B Polymerase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein 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

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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					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
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No

EU/EMA Drug Approvals for SOFOSBUVIR; VELPATASVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Epclusa	sofosbuvir, velpatasvir	EMEA/H/C/004210 Epclusa is indicated for the treatment of chronic hepatitis C virus (HCV) infection in patients 3 years of age and older (see sections 4.2, 4.4 and 5.1).	Authorised	no	no	no	2016-07-06

International Patents for SOFOSBUVIR; VELPATASVIR

Country	Patent Number	Title	Estimated Expiration
Singapore	10201702025S	NUCLEOSIDE PHOSPHORAMIDATES
New Zealand	710567	Antiviral compounds
Lithuania	2609923
Eurasian Patent Organization	201171417	1-МЕТИЛЭТИЛОВЫЙ СЛОЖНЫЙ ЭФИР N-[(2'R)-2'-ДЕЗОКСИ-2'-ФТОР-2'-МЕТИЛ-Р-ФЕНИЛ-5'-УРИДИЛ]-L-АЛАНИНА И СПОСОБ ЕГО ПОЛУЧЕНИЯ
European Patent Office	3431477	IMIDAZOLYLIMIDAZOLES CONDENSÉS EN TANT QUE COMPOSÉS ANTIVIRAUX (CONDENSED IMIDAZOLYLIMIDAZOLES AS ANTIVIRAL COMPOUNDS)
Israel	226346	תרכובות אנטי ויראליות (Antiviral compounds)
Uruguay	34420	?MÉTODOS DE TRATAMIENTO DEL VIRUS DE LA HEPATITIS C CON QUE DE GS-7977 Y RIBAVIRINA, COMPOSICIONES Y USOS"

Supplementary Protection Certificates for SOFOSBUVIR; VELPATASVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	1491066-5	Sweden		PRODUCT NAME: SOFOSBUVIR; FIRST MARKETING AUTHORIZATION NUMBER SE: EG EU/1/13/894, 2014-01-17
2203462	C201430078	Spain		PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894; DATE OF AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894; DATE OF FIRST AUTHORISATION IN EEA: 20140116
2203462	2014/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
2203462	14C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	PA2014040	Lithuania		PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
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
2203462	CA 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116