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Serving hundreds of leading biopharmaceutical companies globally:

McKesson
UBS
Daiichi Sankyo
Argus Health
Merck
US Department of Justice
Farmers Insurance
Cantor Fitzgerald
Chinese Patent Office

Generated: June 21, 2018

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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.
Pharmacology for sofosbuvir
Medical Subject Heading (MeSH) Categories for sofosbuvir
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 ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Gilead Sciences Inc EPCLUSA sofosbuvir; velpatasvir TABLET;ORAL 208341-001 Jun 28, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Sign Up
8,735,372 Nucleoside phosphoramidate prodrugs ➤ Sign Up
8,906,880 Nucleoside phosphoramidate prodrugs ➤ Sign Up
8,957,046 Nucleoside phosphoramidate prodrugs ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for sofosbuvir

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

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Serving hundreds of leading biopharmaceutical companies globally:

Chubb
Johnson and Johnson
Teva
Merck
Deloitte
Fish and Richardson
Julphar
Cipla
Queensland Health

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.