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Generated: May 23, 2019

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SOVALDI Drug Profile

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Which patents cover Sovaldi, and when can generic versions of Sovaldi launch?

Sovaldi is a drug marketed by Gilead Sciences Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has three hundred and twenty-one patent family members in forty-seven countries.

The generic ingredient in SOVALDI is sofosbuvir. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sofosbuvir profile page.

Drug patent expirations by year for SOVALDI
Generic Entry Opportunity Date for SOVALDI
Generic Entry Date for SOVALDI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Medical Subject Heading (MeSH) Categories for SOVALDI
Synonyms for SOVALDI
(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
1190307-88-0
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
AKOS024464753
AM84279
AMMD00019
AMX10213
CHEBI:85083
CHEMBL1259059
CS-0554
D10366
DA-47516
DB08934
EX-A389
GI 7977
GI-7977
GS 7977
GS-7977
GTPL7368
Hepcinat
Hepcvir
HSDB 8226
HY-15005
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-{[(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-((P(S),2'R)-2'-deoxy-2'-fluoro-2'-methyl-P-phenyl-5'-uridylyl)-, 1-methylethyl ester
MolPort-028-720-482
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
PSI 7977
PSI-7977
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
SCHEMBL2010114
SOFOSBUVIR
Sofosbuvir (JAN/USAN)
Sofosbuvir (PSI-7977, GS-7977)
Sofosbuvir [USAN:INN]
Sofosbuvir pound PSI7977 GS-7977 pound(c)
Sofosbuvir(PSI-7977)
Sovaldi (TN)
SoviHep
SW219116-1
UNII-3S5S1851OV component TTZHDVOVKQGIBA-IQWMDFIBSA-N
UNII-WJ6CA3ZU8B
WJ6CA3ZU8B
ZINC100074252

US Patents and Regulatory Information for SOVALDI

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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Gilead Sciences Inc SOVALDI sofosbuvir TABLET;ORAL 204671-001 Dec 6, 2013 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
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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Paragraph IV (Patent) Challenges for SOVALDI
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 400 mg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for SOVALDI

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2203462 300704 Netherlands ➤ Try a Free Trial PRODUCT NAME: SOFOSBUVIR; REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 PA2014040 Lithuania ➤ Try a Free Trial PRODUCT NAME: SOFOSBUVIRUM; REGISTRATION NO/DATE: EU/1/13/894/001 - EU/1/13/894/002 20140116
2203462 122014000108 Germany ➤ Try a Free Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); NAT. REGISTRATION NO/DATE: EU /1/13/894 20140116; FIRST REGISTRATION: EU EU/1/13/894 20140116
2203462 92600 Luxembourg ➤ Try a Free Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR). FIRST REGISTRATION: 20140117
2203462 C300704 Netherlands ➤ Try a Free Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-002 20140117
2203462 2014/065 Ireland ➤ Try a Free Trial PRODUCT NAME: SOVALDI (SOFOSBUVIR); REGISTRATION NO/DATE: EU/1/13/894/001-EU/1/13/894/002 20140116
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Merck

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