Sofosbuvir - Generic Drug Details

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

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

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

There are nine drug master file entries for sofosbuvir.

Summary for sofosbuvir

International Patents:	354
US Patents:	22
Tradenames:	4
Applicants:	2
NDAs:	6
Drug Master File Entries:	9
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	319
Patent Applications:	2,665
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir
What excipients (inactive ingredients) are in sofosbuvir?	sofosbuvir excipients list
DailyMed Link:	sofosbuvir at DailyMed

Recent Clinical Trials for sofosbuvir

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

Sponsor	Phase
Peking University People's Hospital	Phase 4
Tanta University	Phase 3
The University of Queensland	Phase 4

See all sofosbuvir clinical trials

Medical Subject Heading (MeSH) Categories for sofosbuvir

Antiviral Agents

Paragraph IV (Patent) Challenges for SOFOSBUVIR

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SOVALDI	Tablets	sofosbuvir	400 mg	204671	2	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	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes					Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-002	Aug 28, 2019		RX	Yes	Yes					Y
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					Y
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No

EU/EMA Drug Approvals for sofosbuvir

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Sovaldi	sofosbuvir	EMEA/H/C/002798 Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adult and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1)., , For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1., , Sovaldi is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults and paediatric patients aged 3 years and above (see sections 4.2, 4.4 and 5.1)., , For hepatitis C virus (HCV) genotype specific activity, see sections 4.4 and 5.1.,	Authorised	no	no	no	2014-01-16

International Patents for sofosbuvir

Country	Patent Number	Title	Estimated Expiration
Serbia	56975	METODE ZA LEČENJE HCV-A (METHODS FOR TREATING HCV)
Japan	2012527477
South Korea	101599183
Spain	2817886
Spain	2900773

Supplementary Protection Certificates for sofosbuvir

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	132014902310732	Italy		PRODUCT NAME: SOFOSBUVIR(SOVALDI); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/894, 20140117
2203462	PA2014040,C2203462	Lithuania		PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
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	CR 2014 00061	Denmark		PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140117