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Last Updated: April 24, 2024

Sofosbuvir - Generic Drug Details

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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-three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and sixty-two patent family members in forty-eight countries.

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

Summary for sofosbuvir

International Patents:	362
US Patents:	23
Tradenames:	4
Applicants:	2
NDAs:	6
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	49
Clinical Trials:	322
Patent Applications:	1,592
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
M.D. Anderson Cancer Center	Phase 4
Peking University People's Hospital	Phase 4
Tanta University	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	Strength	NDA	ANDAs Submitted	Submissiondate
SOVALDI	Tablets	sofosbuvir	400 mg	204671	2	2017-12-06

US Patents and Regulatory Information for sofosbuvir

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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	EPCLUSA	sofosbuvir; velpatasvir	PELLETS;ORAL	214187-001	Jun 10, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-002	Mar 19, 2020		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gilead Sciences Inc	EPCLUSA	sofosbuvir; velpatasvir	TABLET;ORAL	208341-001	Jun 28, 2016		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for sofosbuvir

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for sofosbuvir

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Country	Patent Number	Title	Estimated Expiration
Colombia	6970603	Composiciones y métodos para tratar el virus de la hepatitis c	⤷ Try a Trial
Portugal	3290428		⤷ Try a Trial
Taiwan	201318627	Methods and compositions for treating hepatitis C virus	⤷ Try a Trial
Canada	2763151	ESTER DE N-[(2 ' R) -2' -DESOXY-2' -FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL]-L-ALANINE 1-METHYLETHYLE ET SON PROCEDE DE PRODUCTION (N- [(2'R) -2'-DEOXY-2'-FLUORO-2' -METHYL-P-PHENYL-5' -URIDYLYL] -L-ALANINE 1-METHYLETHYL ESTER AND PROCESS FOR ITS PRODUCTION)	⤷ Try a Trial
China	106166160	用于治疗HCV的组合物 (Composition for treating HCV)	⤷ Try a Trial
Japan	2017132754	ヌクレオシドホスホロアミデートプロドラッグ (NUCLEOSIDE PHOSPHORAMIDATE PRODRUGS)	⤷ Try a Trial
Spain	2900773		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for sofosbuvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	PA2014040,C2203462	Lithuania	⤷ Try a Trial	PRODUCT NAME: SOFOSBUVIRAS; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462	14C0082	France	⤷ Try a Trial	PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	122014000108	Germany	⤷ Try a Trial	PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462	C20140035	Estonia	⤷ Try a Trial	PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462	C300704	Netherlands	⤷ Try a Trial	PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462	C 2014 043	Romania	⤷ Try a Trial	PRODUCT NAME: SOFOSBUVIR; NATIONAL AUTHORISATION NUMBER: EU/1/13/894(001-002); DATE OF NATIONAL AUTHORISATION: 20140116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/894(001-002); DATE OF FIRST AUTHORISATION IN EEA: 20140116
2635588	C02635588/01	Switzerland	⤷ Try a Trial	PRODUCT NAME: VELPATASVIR + SOFOSBUVIR + VOXILAPREVIR; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66510 08.12.2017
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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