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Last Updated: December 11, 2019

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Phenytoin sodium - Generic Drug Details

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What are the generic drug sources for phenytoin sodium and what is the scope of patent protection?

Phenytoin sodium is the generic ingredient in seven branded drugs marketed by Parke-davis, Lannett, Amneal Pharms Ny, Ani Pharms Inc, Lupin Ltd, Mylan, Sun Pharm Inds, Sun Pharm Inds (in), Taro, Wockhardt, Wockhardt Usa, Watson Labs, Aurobindo Pharma Ltd, Pharmeral, Parke Davis, Acella, Fresenius Kabi Usa, Hospira, Luitpold, Marsam Pharms Llc, Smith And Nephew, Solopak, Warner Chilcott, and West-ward Pharms Int, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for phenytoin sodium. Twenty-eight suppliers are listed for this compound.

Drug Sales Revenue Trends for phenytoin sodium

See drug sales revenues for phenytoin sodium

Recent Clinical Trials for phenytoin sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Eisai Inc.Phase 4
Weill Medical College of Cornell UniversityPhase 4
Instituto Nacional de Salud Publica, MexicoPhase 3

See all phenytoin sodium clinical trials

Synonyms for phenytoin sodium
125-59-7
2-hydroxy-5,5-diphenyl-3,5-dihydro-4H-imidazol-4-one
2, 5,5-diphenyl-
2,4-Imidazolidinedione, 5,5-diphenyl-
2,4-Imidazolidinedione, 5,5-diphenyl- (9CI)
4-hydroxy-5,5-diphenyl-1,5-dihydro-2H-imidazol-2-one
5,5-?Diphenyl-?2,4-?imidazolidinedione
5,5-di(phenyl)imidazolidine-2,4-dione
5,5-diphenyl hydantoin
5,5-diphenyl-1,3-diazolidine-2,4-dione
5,5-diphenyl-1H-imidazole-2,4(3H,5H)-dione
5,5-Diphenyl-1H-imidazolidine-2,4-dione
5,5-diphenyl-2-(sodiooxy)-1H-imidazol-4-one
5,5-Diphenyl-2,4-imidazolidinedione
5,5-Diphenyl-imidazolidine-2,4-dione
5,5-DIPHENYLHYDANTOIN
5,5-Diphenylhydantoin (IUPAC)
5,5-Diphenylhydantoin (phenytoin)
5,5-Diphenylhydantoin sodium
5,5-Diphenylhydantoin sodium salt
5,5-Diphenylhydantoin solution, drug standard, 1.0 mg/mL in methanol
5,5-Diphenylhydantoin, >=99%
5,5-Diphenylhydantoin, 99+%
5,5-DiphenylhydantoinSodiumSalt
5,5-Diphenylimidazolidin-2,4-dione
5,5-diphenylimidazolidine-2,4-dione
5,5-diphenylimidazolidine-2,4-dione.
5,5-diphenyltetrahydro-1H-2,4-imidazoledione
5,5-Dwufenylohydantoina
5,5-Dwufenylohydantoina [Polish]
57-41-0
6158TKW0C5
630-93-3
77737-08-7
A831435
AB00374253_13
AB00374253-10
AB00374253-11
AB01274811-01
AB1000452
AC-376
AC-377
AC1L1C7L
AC1Q6G55
AC1Q6G56
ACMC-1AMO9
AI3-52498
AJ-36438
AK208913
AKOS000416887
AKOS003245432
AKOS025402054
AKOS027256628
Aladdin (Salt/Mix)
Alepsin (Salt/Mix)
Aleviatin
Aleviatin (TN)
Aleviatin; Diphenylhydantoin sodium; Eptoin;
AN-15915
Antisacer
Antisacer (Salt/Mix)
ANW-32714
Auranile
BAS 00281572
BBL027509
BC205386
BCP05960
BDBM50003655
BDBM50101816
BG0287
BIDD:GT0625
BIDD:PXR0090
BRD-K55930204-001-02-7
BRD-K55930204-236-11-0
BSPBio_001437
C07443
CAS-57-41-0
Causoin
CCG-104011
CCG-221633
CCG-221682
CCRIS 515
CHEBI:8107
CHEMBL16
CHEMBL1611
Citrullamon
Citrullamon (Salt/Mix)
Citrulliamon
CJ-08570
Comital
Comitoina
component of Mebroin
Convul
CPD000059026
CS-2559
CS-4639
CTK3J3728
CTK5E4844
CXOFVDLJLONNDW-UHFFFAOYSA-N
D 4007
D 4505
D00512
D02103
D0894
Danten
Dantinal
Dantoinal
Dantoinal klinos
Dantoine
DB00252
Denyl
Di-Hydan
Di-Hydan; Dihycon; Dilabid; Diphedan
Di-Lan
Di-Lan (VAN)
Di-Phetine
Didan TDC 250
Didan-tdc-250
Difenilhidantoina
Difenilhidantoina [Spanish]
Difenin
Difetoin
Difhydan
Dihycon
Dihydan toin
Dihydantoin
Dilabid
Dilantin
Dilantin (TN)
Dilantin acid
Dilantin-125
DILANTIN-30
Dilantine
Dillantin
Dintoin
Dintoina
Diphantoin
Diphedal
Diphedan
Diphenat
Diphenin
Diphenine
Diphentoin
Diphentyn
Diphenylan
Diphenylan sodium
Diphenylhydantoin
Diphenylhydantoin (VAN)
Diphenylhydantoine
Diphenylhydantoine [French]
Diphenylhydatanoin
Ditoinate
DivK1c_000507
DPH (VAN)
DSSTox_CID_541
DSSTox_GSID_20541
DSSTox_RID_75650
DTXSID8020541
EINECS 200-328-6
Ekko
Ekko capsules
elepsi ndon
Elepsindon
EN300-16818
Enkelfel
enytoin sodium
Epamin
Epanutin
epasmir ''5''
Epasmir '5'
Epasmir "5"
Epasmir 5
Epdantoin (Salt/Mix)
Epdantoin Simple
Epdantoine simple
Epelin
Epifenyl
Epihydan
Epilan D
Epilan-D
Epilantin
Epileptin (Salt/Mix)
Epinat
Episar (Salt/Mix)
Epised
Epitope ID:117723
Epsolin (Salt/Mix)
Eptal
Eptoin
EU-0100329
EU-0100378
Extended Phenytoin Sodium
F0020-1370
fen toin
Fenantoin Mn Pharma
fenidantoin ''s''
Fenidantoin 's'
Fenidantoin "s"
Fenidantoin s
Fenigramon (Salt/Mix)
Fenitoin
Fenitoina
Fenitoina [INN-Spanish]
Fentoin
Fenylepsin
Fenytoin Dak
Fenytoine
FJPYVLNWWICYDW-UHFFFAOYSA-M
FT-0699999
Gerot-epilan-D
GTPL2624
Hidan
Hidantal
Hidantilo
Hidantina
Hidantina senosian
Hidantina vitoria
Hidantomin
Hindatal
HMS1412J16
HMS1694O05
HMS1791H19
HMS1989H19
HMS2089E11
HMS2236J06
HMS3261A19
HMS3261K17
HMS3402H19
HMS3651N05
HMS3657O03
HSDB 3160
HY-B0448
HY-B0448A
Hydantal
Hydantin
Hydantoin, 5,5-diphenyl-
Hydantoin, 5,5-diphenyl- (8CI)
Hydantoin,5-diphenyl-
Hydantoinal
Hydantol
I14-6452
ictalis simp le
Ictalis simple
Idantoil
Idantoin
IDI1_000507
IDI1_008433
IFLab1_000214
InChI=1/C15H12N2O2/c18-13-15(17-14(19)16-13,11-7-3-1-4-8-11)12-9-5-2-6-10-12/h1-10H,(H2,16,17,18,19
Iphenylhydantoin
KB-196262
KBio1_000507
KBio2_001585
KBio2_004153
KBio2_006721
KBio3_001780
KBioGR_001387
KBioSS_001585
Kessodanten
KS-00000C9F
KS-00000C9G
KSC493O2R
Labopal
Lehydan
Lepitoin
Lepsin
Lopac-D-4007
Lopac-D-4505
Lopac0_000329
Lopac0_000378
LP00329
LP00378
MCULE-2376673346
MFCD00005264
Minetoin
MLS000069789
MLS001074087
MLS002454401
MolPort-001-785-683
MolPort-002-365-712
MolPort-003-983-450
MolPort-005-935-649
MolPort-023-220-142
NCGC00015342-01
NCGC00015342-02
NCGC00015342-03
NCGC00015342-04
NCGC00015342-05
NCGC00015342-06
NCGC00015342-07
NCGC00015342-08
NCGC00015342-09
NCGC00015342-10
NCGC00016142-01
NCGC00016142-02
NCGC00021139-01
NCGC00021139-02
NCGC00021139-03
NCGC00021139-04
NCGC00021139-05
NCGC00021139-06
NCGC00021139-07
NCGC00021139-08
NCGC00021139-09
NCGC00021139-10
NCGC00021139-11
NCGC00091492-01
NCGC00091492-02
NCGC00091492-03
NCGC00091492-04
NCGC00091492-05
NCGC00093769-01
NCGC00093810-01
NCGC00093810-02
NCGC00254135-01
NCGC00259848-01
NCGC00261014-01
NCGC00261063-01
NCI-C55765
NE10390
Neos-Hidantoina
Neosidantoina
NINDS_000507
Novantoina
Novophenytoin
NSC 8722
NSC-8722
NSC8722
Om hidantoina simple
Om-Hydantoine
Opera_ID_394
Oprea1_373280
OROS-Phenytoin
Oxylan
P-235
Phanantin
Phanatine
phenat ine
Phenatine
Phenatoine
Phenhydan
Phenhydanin
Phenitoin
Phentoin
Phentytoin
PHENYTEK
Phenytex
phenytoin
PHENYTOIN (5,5-DIPHENYLHYDANTOIN)
Phenytoin (JP17/USP/INN)
Phenytoin (Lepitoin)
phenytoin (PHN)
Phenytoin (sodium)
Phenytoin [USAN:INN:BAN:JAN]
Phenytoin [USAN:USP:INN:BAN:JAN]
Phenytoin 1.0 mg/ml in Methanol
Phenytoin AWD
Phenytoin for system suitability, European Pharmacopoeia (EP) Reference Standard
Phenytoin sodium (Dilantin)
Phenytoin sodium (USP)
Phenytoin sodium for injection (JP17)
PHENYTOIN SODIUM, EXTENDED
Phenytoin soluble
Phenytoin solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Phenytoin-Gerot
Phenytoin, European Pharmacopoeia (EP) Reference Standard
Phenytoin, Pharmaceutical Secondary Standard; Certified Reference Material
Phenytoin, United States Pharmacopeia (USP) Reference Standard
Phenytoine
Phenytoine [INN-French]
Phenytoinum
Phenytoinum [INN-Latin]
Prompt; Phenytek
Ritmenal
RTR-037347
s2524
s2525
Saceril
SAM002554893
Sanepil
SBB057224
SC-16138
SC-39400
SCHEMBL3440
SCHEMBL9792827
Silantin
Sinergina
SMR000059026
Sodanthon
Sodantoin
Sodanton
sodium 4-oxo-5,5-diphenyl-4,5-dihydro-1H-imidazol-2-olate
SODIUM 5-OXO-4,4-DIPHENYL-1H-IMIDAZOL-2-OLATE
Sodium Diphenylhydantoinate
sodium;4-oxo-5,5-diphenyl-1H-imidazol-2-olate
Solantin
Solantoin
Solantyl
Soluble phenytoin (Salt/Mix)
SPBio_001281
Spectrum_001105
Spectrum2_001281
Spectrum3_000890
Spectrum4_000984
Spectrum5_001369
SR-01000003141
SR-01000003141-8
SR-01000075211
SR-01000075211-2
ST45024762
STK058029
STK182871
STL454130
SW203757-2
SW220143-1
Sylantoic
taco sal
Tacosal
Tacosal (Salt/Mix)
Thilophenyl
TL8004381
TOIN
Toin unicelles
Tox21_110861
Tox21_110861_1
Tox21_202299
Tox21_300281
Tox21_500329
Tox21_500378
TR-037347
TRA0089622
UNII-6158TKW0C5
W-105468
WLN: T5MVMV EHJ ER& ER
Z56786458
Zentronal
Zentropil
ZINC2510358

US Patents and Regulatory Information for phenytoin sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmeral PHENYTOIN SODIUM phenytoin sodium CAPSULE;ORAL 085435-001 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Warner Chilcott PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089900-001 Mar 30, 1990 DISCN No No   Start Trial   Start Trial   Start Trial
Marsam Pharms Llc PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089501-001 Oct 13, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan PHENYTEK phenytoin sodium CAPSULE;ORAL 040298-003 Dec 6, 2001 AB RX No Yes   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa PHENYTOIN SODIUM phenytoin sodium INJECTABLE;INJECTION 089003-001 May 31, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Parke-davis DILANTIN phenytoin sodium CAPSULE;ORAL 084349-001 Approved Prior to Jan 1, 1982 RX No Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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