gabapentin Extended Release Oral Tablet

Brand(s)
Horizant
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Xenoport Inc. (2015-07-14)
Oldest Current Product
2013-05-01
License(s)
NDA
RxNORM
EXTENDED RELEASE ORAL TABLET\GABAPENTIN
FDAOB
ORAL\TABLET, EXTENDED RELEASE\GABAPENTIN ENACARBIL
SPL Active
ORAL\TABLET, EXTENDED RELEASE\GABAPENTIN ENACARBIL
SPL Moiety
ORAL\TABLET, EXTENDED RELEASE\GABAPENTIN

product(s) by strength(s)

gabapentin enacarbil 300 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534510103HorizantNDAXenoport Inc.2013-05-01GABAPENTIN ENACARBILORALTABLET, EXTENDED RELEASENDA0223994c486fc7-c8c4-4c6c-b30c-366dabaeaadd

gabapentin enacarbil 600 mg extended release oral tablet

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1534510101HorizantNDAXenoport Inc.2013-05-01GABAPENTIN ENACARBILORALTABLET, EXTENDED RELEASENDA0223994c486fc7-c8c4-4c6c-b30c-366dabaeaadd

application(s)

#idtitleapplicantapprovedpatentexclusivityapproved drug
1NDA022399HORIZANTXENOPORT INC2011-04-06p8026279, SUBSTANCE
p6818787, SUBSTANCE
p8048917, MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS, SUBSTANCE
p8795725, TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS/ MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS, SUBSTANCE
p8686034, TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS/ MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
p8114909, TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
MANAGEMENT OF POSTHERPETIC NEURALGIA [2015-06-06]
ORPHAN DRUG EXCLUSIVITY [2019-06-06]
NEW CHEMICAL ENTITY [2016-04-06]
NDA022399_001, NDA022399_002

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA022399_001RXGABAPENTIN ENACARBIL (600MG)ORALTABLET, EXTENDED RELEASETrue2011-04-06HORIZANT
2NDA022399_002RXGABAPENTIN ENACARBIL (300MG)ORALTABLET, EXTENDED RELEASEFalse2011-12-13HORIZANT

patent(s)

#idexpiration dateapplication(s)
1p6818787 (view patent)2022-11-06NDA022399
2p8026279 (view patent)2026-11-10NDA022399
3p8048917 (view patent)2022-11-06NDA022399
4p8114909 (view patent)2026-04-11NDA022399
5p8686034 (view patent)2025-01-24NDA022399
6p8795725 (view patent)2029-06-10NDA022399

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
14c486fc7-c8c4-4c6c-b30c-366dabaeaadd (view SPL)These highlights do not include all the information needed to use HORIZANT safely and effectively. See full prescribing information for HORIZANT. HORIZANT (gabapentin enacarbil) Extended-Release Tablets for oral useInitial U.S. Approval: 2011prescriptionHuman PrescriptionXenoport Inc.ANALYSIS, LABEL, MANUFACTURE2015-07-145534510101, 534510103

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