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Generated: May 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 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 eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sofosbuvir has three hundred and twenty-one patent family members in forty-seven 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
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

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 VOSEVI sofosbuvir; velpatasvir; voxilaprevir TABLET;ORAL 209195-001 Jul 18, 2017 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 Y Y ➤ 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
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 ➤ 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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Supplementary Protection Certificates for sofosbuvir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 14C0082 France ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 122014000108 Germany ➤ Sign Up PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462 C20140035 00135 Estonia ➤ Sign Up PRODUCT NAME: SOFOSBUVIIR;REG NO/DATE: EU/1/13/894 17.01.2014
2203462 67/2014 Austria ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894 20140117
2203462 2014029 Norway ➤ Sign Up PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
2203462 C02203462/01 Switzerland ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: SWISSMEDIC 63218 18.03.2014
2203462 CA 2014 00061 Denmark ➤ Sign Up PRODUCT NAME: SOFOSBUVIR; REG. NO/DATE: EU/1/13/894/001-002 20140116
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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