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Last Updated: November 20, 2019

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Sofosbuvir - Generic Drug Details

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What are the generic sources for sofosbuvir and what is the scope of patent protection?

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

Sofosbuvir has three hundred and thirty-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:	331
US Patents:	18
Tradenames:	3
Applicants:	1
NDAs:	4
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	69
Clinical Trials:	278
Patent Applications:	204
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

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Sponsor	Phase
Kirby Institute	N/A
University of Kentucky	Phase 4
National Cancer Institute (NCI)	Phase 4

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Recent Litigation for sofosbuvir

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District Court Litigation

Case Name	Date
Gilead Sciences, Inc. v. Teva Pharmaceuticals USA, Inc.	2018-03-27
GILEAD SCIENCES, INC. v. NATCO PHARMA LIMITED	2018-03-14
Idenix Pharmaceuticals LLC v. Gilead Sciences, Inc.	2014-07-01

See all sofosbuvir litigation

PTAB Litigation

Petitioner	Date
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-12-26
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-11-02
Initiative for Medicines, Access & Knowledge (I-MAK), Inc.	2017-10-30

See all sofosbuvir litigation

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

Synonyms for sofosbuvir

(S)-2-{[(1R,4R,5R)-5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-(R)-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy]phenoxyphosphorylamino}propionic acid (S)-isopropyl ester
(S)-isopropyl 2-(((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)amino)propanoate
1064684-44-1
1190307-88-0
1221574-17-9
1421833-87-5
2-((5-(2,4-dioxo-3,4-dihydro-2H-pyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-ylmethoxy)phenoxyphosphorylamino)propionic acid isopropyl ester
AB0109660
AC-27382
AKOS024464753
AKOS025401925
AM84279
AMMD00019
AMX10213
AOB6269
AS-19600
C22H29FN3O9P
CHEBI:85083
CHEMBL1258950
CHEMBL1259059
CHEMBL3186678
CS-0554
D10366
DA-47516
DB08934
EX-A389
GI 7977
GI-7977
GS 7977
GS-7977
GS-9851
GTPL7368
Hepcinat
Hepcvir
HSDB 8226
HY-15005
isopropyl ((((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate
isopropyl ((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)(phenoxy)phosphoryl)-L-alaninate
isopropyl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate
isopropyl (2S)-2-[[[(3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyl-tetrahydrofuran-2-yl]methoxy-phenoxy-phosphoryl]amino]propanoate
isopropyl (2S)-2-{[(S)-{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate
KB-80152
L-Alanine, N-((2'R)-2'-deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-, 1-methylethyl ester
L-Alanine, N-((P(S),2'R)-2'-deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridylyl)-, 1-methylethyl ester
MolPort-028-720-482
MolPort-028-720-483
N-((2'R)-2'-Deoxy-2'-fluoro-2'-methyl-p-phenyl-5'-uridylyl)-L-alanine 1-methylethyl ester
propan-2-yl (2S)-2-[[[(2R,3R,4R,5R)-5-(2,4-dioxopyrimidin-1-yl)-4-fluoro-3-hydroxy-4-methyloxolan-2-yl]methoxy-phenoxyphosphoryl]amino]propanoate
Propan-2-yl (2S)-2-{[{[(2R,3R,4R,5R)-5-(2,4-dioxo-3,4-dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl]methoxy}(phenoxy)phosphoryl]amino}propanoate (non-preferred name)
psi 7851
PSI 7977
PSI-7851
PSI-7977
Q-4112
QC-10465
Resof
S)-Isopropyl 2-((S)-(((2R,3R,4R,5R)-5-(2,4-dioxo-3,4- dihydropyrimidin-1(2H)-yl)-4-fluoro-3-hydroxy-4-methyltetrahydrofuran-2-yl)methoxy)- (phenoxy)phosphorylamino)propanoate
s2794
SB20304
SC-87382
SCHEMBL18061557
SCHEMBL2003999
SCHEMBL2010114
Sofosbuvir (JAN/USAN)
Sofosbuvir (PSI-7977, GS-7977)
Sofosbuvir [USAN:INN]
Sofosbuvir pound PSI7977 GS-7977 pound(c)
Sofosbuvir(PSI-7977)
SOVALDI
Sovaldi (TN)
SoviHep
SW219116-1
UNII-3S5S1851OV component TTZHDVOVKQGIBA-IQWMDFIBSA-N
UNII-3S5S1851OV component TTZHDVOVKQGIBA-YBSJRAAASA-N
UNII-WJ6CA3ZU8B
WJ6CA3ZU8B
Y1293
ZINC100074252

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

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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	SOVALDI	sofosbuvir	TABLET;ORAL	204671-002	Aug 28, 2019		RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	SOVALDI	sofosbuvir	PELLETS;ORAL	212480-001	Aug 28, 2019		RX	Yes	No	Start Trial	Start Trial			Y	Start Trial
Gilead Sciences Inc	VOSEVI	sofosbuvir; velpatasvir; voxilaprevir	TABLET;ORAL	209195-001	Jul 18, 2017		RX	Yes	Yes	Start Trial	Start Trial	Y	Y		Start Trial
>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

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Country	Patent Number	Estimated Expiration
Brazil	112012024884	Start Trial
South Korea	101599183	Start Trial
Spain	2659216	Start Trial
Eurasian Patent Organization	026667	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for sofosbuvir

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2203462	1490066-6	Sweden	Start Trial	PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894 20140117
2203462	2014029	Norway	Start Trial	PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462	PA2014040	Lithuania	Start Trial	PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2430014	92956	Luxembourg	Start Trial	PRODUCT NAME: LEDIPASVIR; AUTHORISATION NUMBER AND DATE: EU/1/14/958 - HARVONI (LEDIPASVIR-SOFOSBUVIR) 20141118
>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 verifification 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.

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