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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 sofosbuvir patent protection?

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

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

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

Summary for sofosbuvir

International Patents:	302
US Patents:	17
Tradenames:	3
Applicants:	1
NDAs:	3
Drug Master File Entries:	9
Suppliers / Packagers:	1
Bulk Api Vendors:	62
Clinical Trials:	230
Patent Applications:	175
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for sofosbuvir
DailyMed Link:	sofosbuvir at DailyMed

Pharmacology for sofosbuvir

Ingredient-type	Nucleoside Analog
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

AK172330

AKOS024464753

AKOS025401925

AM013398

AM84279

AMMD00019

AMX10213

AOB6269

AS-19600

C22H29FN3O9P

CHEBI:85083

CHEMBL1258950

CHEMBL1259059

CS-0554

D0A6OO

D0D4YZ

D10366

DA-47516

DB08934

EX-A389

GI 7977

GI-7977

GS 7977

GS 7977;PSI 7977;sofosbuvir

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

ISOPROPYL 2-({[5-(2,4-DIOXO-3H-PYRIMIDIN-1-YL)-4-FLUORO-3-HYDROXY-4-METHYLOXOLAN-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

Psi-7977, sofosbuvir

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

SC-87382

SCHEMBL18061557

SCHEMBL2003999

SCHEMBL2010114

Sofosbuvir (JAN/USAN)

Sofosbuvir [USAN:INN]

Sofosbuvir pound PSI7977 GS-7977 pound(c)

Sofosbuvir(PSI-7977)

SOVALDI

Sovaldi (TN)

SoviHep

UNII-3S5S1851OV component TTZHDVOVKQGIBA-IQWMDFIBSA-N

UNII-3S5S1851OV component TTZHDVOVKQGIBA-YBSJRAAASA-N

UNII-WJ6CA3ZU8B

WJ6CA3ZU8B

Y1293

ZINC100074252

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	Y
Gilead Sciences Inc	SOVALDI	sofosbuvir	TABLET;ORAL	204671-001	Dec 6, 2013		RX	Yes	Yes			Y	Y
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	Y

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Non-Orange Book US Patents for sofosbuvir

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,393,256	Methods for treating HCV
8,735,372	Nucleoside phosphoramidate prodrugs
8,906,880	Nucleoside phosphoramidate prodrugs
8,957,046	Nucleoside phosphoramidate prodrugs

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International Patents for sofosbuvir

Country	Document Number	Estimated Expiration
Israel	232889
Brazil	PI0823519
Eurasian Patent Organization	201592101
Hungary	E034239

Supplementary Protection Certificates for sofosbuvir

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0140035 00135	Estonia		PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
C0082	France		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462/01	Switzerland		PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
14/065	Ireland		PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116