sacubitril / valsartan Oral Tablet

Brand(s)
Entresto
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Novartis Pharmaceuticals Corporation (2015-08-13)
Oldest Current Product
2015-07-07
License(s)
NDA
RxNORM
ORAL TABLET\SACUBITRIL:VALSARTAN
FDAOB
ORAL\TABLET\SACUBITRIL: VALSARTAN
SPL Active
ORAL\TABLET, FILM COATED\SACUBITRIL: VALSARTAN
SPL Moiety
ORAL\TABLET, FILM COATED\SACUBITRIL: VALSARTAN

product(s) by strength(s)

sacubitril 24 mg / valsartan 26 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780659EntrestoNDANovartis Pharmaceuticals Corporation2015-07-07SACUBITRIL, VALSARTANORALTABLET, FILM COATEDNDA207620000dc81d-ab91-450c-8eae-8eb74e72296f

sacubitril 49 mg / valsartan 51 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780777EntrestoNDANovartis Pharmaceuticals Corporation2015-07-07SACUBITRIL, VALSARTANORALTABLET, FILM COATEDNDA207620000dc81d-ab91-450c-8eae-8eb74e72296f

sacubitril 97 mg / valsartan 103 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000780696EntrestoNDANovartis Pharmaceuticals Corporation2015-07-07SACUBITRIL, VALSARTANORALTABLET, FILM COATEDNDA207620000dc81d-ab91-450c-8eae-8eb74e72296f

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA207620ENTRESTONOVARTIS PHARMACEUTICALS CORP2015-07-07p8796331, TREATMENT OF HEART FAILURE
p8404744, SUBSTANCE
p8101659, SUBSTANCE
p8877938, SUBSTANCE
p7468390, SUBSTANCE
NEW CHEMICAL ENTITY [2020-07-07]NDA207620_001, NDA207620_002, NDA207620_003

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA207620_001RXSACUBITRIL (24MG), VALSARTAN (26MG)ORALTABLETFalse2015-07-07ENTRESTO
2NDA207620_002RXVALSARTAN (51MG), SACUBITRIL (49MG)ORALTABLETFalse2015-07-07ENTRESTO
3NDA207620_003RXSACUBITRIL (97MG), VALSARTAN (103MG)ORALTABLETTrue2015-07-07ENTRESTO

patent(s)

#idexpiration dateapplication(s)
1p7468390 (view patent)2023-11-27NDA207620
2p8101659 (view patent)2023-01-14NDA207620
3p8404744 (view patent)2023-01-14NDA207620
4p8796331 (view patent)2023-01-14NDA207620
5p8877938 (view patent)2027-05-27NDA207620

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
1000dc81d-ab91-450c-8eae-8eb74e72296f (view SPL)These highlights do not include all the information needed to use ENTRESTO safely and effectively. See full prescribing information for ENTRESTO. ENTRESTO (sacubitril and valsartan) tablets, for oral use Initial U.S. Approval: 2015prescriptionHuman PrescriptionNovartis Pharmaceuticals Corporation2015-08-132000780659, 000780696, 000780777

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