phenylbutyrate Oral Solution

Brand(s)
Ravicti
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hyperion Therapeutics, Inc. (2013-02-08)
Oldest Current Product
2013-02-28
License(s)
NDA
RxNORM
ORAL SOLUTION\PHENYLBUTYRATE
FDAOB
ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE
SPL Active
ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE
SPL Moiety
ORAL\LIQUID\GLYCEROL PHENYLBUTYRATE

product(s) by strength(s)

glycerol phenylbutyrate 1100 mg/ml oral solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1763250100RavictiNDAHyperion Therapeutics, Inc.2013-02-28GLYCEROL PHENYLBUTYRATEORALLIQUIDNDA20328473bc6b83-2513-11e1-bfc2-0800200c9a66

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA203284RAVICTIHORIZON THERAPEUTICS INC2013-02-01p8404215, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
p8642012, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
p9095559, DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE DISORDER
p5968979, TREATMENT OF A NITROGEN METAOLISM DISORDER, SUBSTANCE
ORPHAN DRUG EXCLUSIVITY [2020-02-01]
NEW ESTER OR SALT OF AN ACTIVE INGREDIENT [2016-02-01]
NDA203284_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA203284_001RXGLYCEROL PHENYLBUTYRATE (1.1GM/ML)ORALLIQUIDTrue2013-02-01RAVICTI

patent(s)

#idexpiration dateapplication(s)
1p5968979 (view patent)2015-02-07NDA203284
2p8404215 (view patent)2032-03-09NDA203284
3p8642012 (view patent)2030-09-22NDA203284
4p9095559 (view patent)2032-03-09NDA203284

spl(s)

#idtitlecategorytypelabelerlast updateversionproduct(s)
173bc6b83-2513-11e1-bfc2-0800200c9a66 (view SPL)These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI (glycerol phenylbutyrate) oral liquid Initial U.S. Approval: 1996prescriptionHuman PrescriptionHyperion Therapeutics, Inc.2013-02-082763250100
2900e7dc0-9afe-4f50-80de-90567bb78519 (view SPL)These highlights do not include all the information needed to use RAVICTI safely and effectively. See full prescribing information for RAVICTI. RAVICTI (glycerol phenylbutyrate) Oral Liquid Initial U.S. Approval: 1996prescriptionHuman PrescriptionHorizon Pharma, Inc.2015-10-071759870050

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