ledipasvir / sofosbuvir Oral Tablet

Brand(s)
Harvoni
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Gilead Sciences, Inc. (2015-11-18)
Oldest Current Product
2014-10-10
License(s)
NDA, EXPORT ONLY
RxNORM
ORAL TABLET\LEDIPASVIR:SOFOSBUVIR
FDAOB
ORAL\TABLET\LEDIPASVIR: SOFOSBUVIR
SPL Active
ORAL\TABLET, FILM COATED\LEDIPASVIR: SOFOSBUVIR
SPL Moiety
ORAL\TABLET, FILM COATED\LEDIPASVIR: SOFOSBUVIR

product(s) by strength(s)

ledipasvir 90 mg / sofosbuvir 400 mg oral tablet

export only product(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formspl
1619581802HarvoniEXPORT ONLYGilead Sciences, Inc.2014-10-10LEDIPASVIR, SOFOSBUVIRORALTABLET, FILM COATED1a1c555d-2fdf-4150-8ace-dbc770c226bf

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1619581801HarvoniNDAGilead Sciences, Inc.2014-10-10LEDIPASVIR, SOFOSBUVIRORALTABLET, FILM COATEDNDA205834f4ec77e4-bae8-4db0-b3d5-bde09c5fa075

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA205834HARVONIGILEAD SCIENCES INC2014-10-10p9085573, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8088368, SUBSTANCE
p7964580, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8633309, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8618076, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8735372, FOR THE TREATMENT OF HEPATITIS C
p8822430, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8889159, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8841278, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8334270, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
p8273341, FOR THE TREATMENT OF HEPATITIS C
p8580765, FOR THE TREATMENT OF HEPATITIS C, SUBSTANCE
NEW CHEMICAL ENTITY [2019-10-10]NDA205834_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA205834_001RXSOFOSBUVIR (400MG), LEDIPASVIR (90MG)ORALTABLETTrue2014-10-10HARVONI

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7964580 (view patent)2029-03-26NDA205834, NDA204671sofosbuvir Oral Tablet
2p8088368 (view patent)2030-05-12NDA205834
3p8273341 (view patent)2030-05-12NDA205834
4p8334270 (view patent)2028-03-21NDA205834, NDA204671sofosbuvir Oral Tablet
5p8580765 (view patent)2028-03-21NDA205834, NDA204671sofosbuvir Oral Tablet
6p8618076 (view patent)2030-12-11NDA205834, NDA204671sofosbuvir Oral Tablet
7p8633309 (view patent)2029-03-26NDA205834, NDA204671sofosbuvir Oral Tablet
8p8735372 (view patent)2028-03-21NDA205834
9p8822430 (view patent)2030-05-12NDA205834
10p8841278 (view patent)2030-05-12NDA205834
11p8889159 (view patent)2029-03-26NDA205834, NDA204671sofosbuvir Oral Tablet
12p9085573 (view patent)2028-03-21NDA205834, NDA204671sofosbuvir Oral Tablet

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
11a1c555d-2fdf-4150-8ace-dbc770c226bf (view SPL)These highlights do not include all the information needed to use HARVONI safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use GILEAD ACCESS PROGRAM Initial U.S. Approval: 2014prescriptionHuman PrescriptionGilead Sciences, Inc.2014-10-311619581802
2f4ec77e4-bae8-4db0-b3d5-bde09c5fa075 (view SPL)These highlights do not include all the information needed to use HARVONI safely and effectively. See full prescribing information for HARVONI. HARVONI (ledipasvir and sofosbuvir) tablets, for oral use Initial U.S. Approval: 2014prescriptionHuman PrescriptionGilead Sciences, Inc.2015-11-184619581801

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