Sapropterin Oral Tablet

Brand(s)
Kuvan
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Biomarin Pharmaceutical Inc. (2015-07-08)
Oldest Current Product
2007-12-14
License(s)
NDA
RxNORM
ORAL TABLET\SAPROPTERIN
FDAOB
ORAL\TABLET\SAPROPTERIN DIHYDROCHLORIDE
SPL Active
ORAL\TABLET\SAPROPTERIN DIHYDROCHLORIDE
SPL Moiety
ORAL\TABLET\SAPROPTERIN

product(s) by strength(s)

sapropterin dihydrochloride 100 mg oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1681350300KuvanNDABiomarin Pharmaceutical Inc.2007-12-14SAPROPTERIN DIHYDROCHLORIDEORALTABLETNDA022181af38711e-8873-4790-a92d-4d583e23fb89

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022181KUVANBIOMARIN PHARMACEUTICAL INC2007-12-13p7566714, FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
p7566462, SUBSTANCE
p8067416, FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM HYPERPHENYLALANINEMIA
p8318745, SUBSTANCE
p8003126
p7612073, TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH FOOD TO INCREASE ABSORPTION
p7727987, SUBSTANCE
p7947681, TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)
pRE43797, TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA (HPA)
NEW PATIENT POPULATION [2017-04-23]
ORPHAN DRUG EXCLUSIVITY [2014-12-13]
PEDIATRIC EXCLUSIVITY [2015-06-13]
PEDIATRIC EXCLUSIVITY [2017-10-23]
NDA022181_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022181_001RXSAPROPTERIN DIHYDROCHLORIDE (100MG)ORALTABLETTrue2007-12-13KUVAN

patent(s)

#idexpiration dateapplication(s)in other drug docs
1p7566462 (view patent)2025-11-16NDA022181
2p7566714 (view patent)2024-11-17NDA022181, NDA205065Sapropterin Powder for Oral Solution
3p7612073 (view patent)2024-11-17NDA022181, NDA205065Sapropterin Powder for Oral Solution
4p7727987 (view patent)2024-11-17NDA022181
5p7947681 (view patent)2024-11-17NDA022181
6p8003126 (view patent)2025-11-16NDA022181
7p8067416 (view patent)2024-11-17NDA022181, NDA205065Sapropterin Powder for Oral Solution
8p8318745 (view patent)2024-11-17NDA022181
9pRE43797 (view patent)2024-11-17NDA022181, NDA205065Sapropterin Powder for Oral Solution

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1af38711e-8873-4790-a92d-4d583e23fb89 (view SPL)These highlights do not include all the information needed to use KUVAN safely and effectively. See full prescribing information for KUVAN. KUVAN (sapropterin dihydrochloride) tablets, for oral useKUVAN (sapropterin dihydrochloride) powder, for oral solutionInitial U.S. Approval: 2007prescriptionHuman PrescriptionBiomarin Pharmaceutical Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-07-0835681350300, 681350301, 681350482Sapropterin Powder for Oral Solution

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