sofosbuvir Oral Tablet

Brand(s)
Sovaldi
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-08-28)
Oldest Current Product
2013-12-06
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\SOFOSBUVIR
FDAOB
ORAL\TABLET\SOFOSBUVIR
SPL Active
ORAL\TABLET, FILM COATED\SOFOSBUVIR
SPL Moiety
ORAL\TABLET, FILM COATED\SOFOSBUVIR

product(s) by strength(s)

sofosbuvir 400 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619581502SovaldiEXPORT ONLYGilead Sciences, Inc.2013-12-06SOFOSBUVIRORALTABLET, FILM COATEDb66d2de5-8550-4015-9c2c-d7a9150926b4

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581501SovaldiNDAGilead Sciences, Inc.2013-12-06SOFOSBUVIRORALTABLET, FILM COATEDNDA20467180beab2c-396e-4a37-a4dc-40fdb62859cf

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA204671SOVALDIGILEAD SCIENCES INC2013-12-06p9085573, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p7964580, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8633309, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8889159, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8618076, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8334270, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8580765, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
NEW CHEMICAL ENTITY [2018-12-06]NDA204671_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA204671_001RXSOFOSBUVIR (400MG)ORALTABLETTrue2013-12-06SOVALDI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7964580 (view patent)2029-03-26NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
2p8334270 (view patent)2028-03-21NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
3p8580765 (view patent)2028-03-21NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
4p8618076 (view patent)2030-12-11NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
5p8633309 (view patent)2029-03-26NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
6p8889159 (view patent)2029-03-26NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet
7p9085573 (view patent)2028-03-21NDA204671, NDA205834ledipasvir / sofosbuvir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
180beab2c-396e-4a37-a4dc-40fdb62859cf (view SPL)These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. SOVALDI (sofosbuvir) tablets, for oral useInitial U.S. Approval: 2013prescriptionHuman PrescriptionGilead Sciences, Inc.2015-08-285619581501
2b66d2de5-8550-4015-9c2c-d7a9150926b4 (view SPL)These highlights do not include all the information needed to use SOVALDI safely and effectively. See full prescribing information for SOVALDI. GILEAD ACCESS PROGRAM SOVALDI (sofosbuvir) tablets, for oral use Initial U.S. Approval: 2013prescriptionHuman PrescriptionGilead Sciences, Inc.2015-03-042619581502

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII