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Generated: November 12, 2018

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Primidone - Generic Drug Details

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What are the generic drug sources for primidone and what is the scope of primidone freedom to operate?

Primidone is the generic ingredient in two branded drugs marketed by Nuro Pharma, Valeant, Amneal Pharm, Anda Repository, Dr Reddys Labs Ltd, Hikma Intl Pharms, Impax Labs, Lannett, Oxford Pharms, and Watson Labs, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for primidone. Sixteen suppliers are listed for this compound.

Pharmacology for primidone
Medical Subject Heading (MeSH) Categories for primidone
Synonyms for primidone
125-33-7
125P337
13AFD7670Q
2-Deoxyphenobarbital
2-Desoxyphenobarbital
4,4'-(Hexamethylenedioxy)dibenzamidine
4,5H)-Pyrimidinedione, 5-ethyldihydro-5-phenyl-
4,6(1H,5H)-Pyrimidinedione, 5-ethyldihydro-5-phenyl-
5-24-08-00102 (Beilstein Handbook Reference)
5-Aethyl-5-phenyl-hexahydropyrimidin-4,6-dion
5-Aethyl-5-phenyl-hexahydropyrimidin-4,6-dion [German]
5-ethyl-5-phenyl-1,2,3,5-tetrahydropyrimidine-4,6-dione
5-ethyl-5-phenyl-1,3-diazinane-4,6-dione
5-ethyl-5-phenyl-hexahydropyrimidine-4,6-dione
5-Ethyl-5-phenyldihydro-4,6(1H,5H)-pyrimidinedione
5-Ethyl-5-phenyldihydro-4,6(1H,5H)-pyrimidinedione #
5-ethyl-5-phenyldihydropyrimidine-4,6(1H,5H)-dione
5-Ethyl-5-phenylhexahydropyrimidine-4,6-dione
5-Ethyldihydro-5-phenyl-4,5H)-pyrimidinedione
5-Ethyldihydro-5-phenyl-4,6(1H,5H)-pyrimidinedione
5-ethyldihydro-5-phenyl-4,6[1H,5H]-pyrimidinedione
5-ethylhe xahydro-4,6-dioxo-5-phenylpyrimidine
5-Ethylhexahydro-4,6-dioxo-5-phenylpyrimidine
5-Ethylhexahydro-5-phenylpyrimidine-4,6-dione
5-Phenyl-5-aethylhexahydropyrimidindion-(4,6)
5-Phenyl-5-aethylhexahydropyrimidindion-(4,6) [German]
5-Phenyl-5-ethyl-hexahydropyrimidine-4,6-dione
A805374
AB00052079
AB00052079_15
AB00052079_16
AB00052079-14
AB0013274
AB2000396
AC1L1J82
AKOS003368409
AN-22963
ANW-42020
API0003929
Apo-Primidone
Apo-Primidone (TN)
Apotex Brand of Primidone
Astra Brand of Primidone
AstraZeneca Brand of Primidone
BC682375
BG0404
BIDD:GT0319
Biomol-NT_000261
BPBio1_000859
BPBio1_000954
BRD-K32247306-001-05-4
BRN 0218034
BSPBio_000866
BSPBio_002225
C07371
CAS-125-33-7
CC-33920
CCG-39231
CCRIS 54
CHEBI:8412
CHEMBL856
CPD000058501
CS-2381
CTK8B3224
Cyral
D00474
D0U5RT
DB00794
Desitin Brand of Primidone
Desoxyphenobarbital
Desoxyphenobarbitone
DivK1c_000324
DQMZLTXERSFNPB-UHFFFAOYSA-N
DR000411
Draxis Brand of Primidone
DSSTox_CID_3510
DSSTox_GSID_23510
DSSTox_RID_77058
DTXSID7023510
EINECS 204-737-0
EU-0101021
FT-0603328
GTPL5338
H808
HE288366
HE303716
Hexadiona
hexamidine (the antispasmodic)
Hexamidine (the antispasmodic)
Hexamidine(the antispasmodic)
HMS1570L08
HMS1920J20
HMS2092A21
HMS2097L08
HMS2236G03
HMS3259K04
HMS3263M03
HMS3266H18
HMS3369J12
HMS3655L05
HMS501A06
Holsten Brand of Primidone
HSDB 3169
HY-B0339
I06-0632
IDI1_000324
J-005215
K-1838
KBio1_000324
KBio2_001312
KBio2_003880
KBio2_006448
KBio3_001725
KBioGR_000969
KBioSS_001312
KS-00000XM8
KS-5217
Lepimidin
Lepsiral
Liskantin
Liskantin (TN)
Lopac-P-7295
Lopac0_001021
LP01021
LS-48
Majsolin
MCULE-2519004832
Medi-Pets
Midone
Milepsin
Misodine
Misolyne
Mizodin
Mizolin
MLS000028593
MLS001055411
MLS001074125
MolPort-001-783-659
Myidone
Mylepsin
Mylepsinum
Mylepsinum (TN)
Mysedon
Mysoline
Mysoline (TN)
Mysoline;Neurosyn;Mylepsin
NC00532
NCGC00015834-01
NCGC00015834-02
NCGC00015834-03
NCGC00015834-04
NCGC00015834-05
NCGC00015834-06
NCGC00015834-07
NCGC00015834-08
NCGC00015834-09
NCGC00015834-10
NCGC00015834-11
NCGC00015834-12
NCGC00015834-13
NCGC00015834-14
NCGC00015834-15
NCGC00015834-16
NCGC00015834-17
NCGC00015834-19
NCGC00016377-01
NCGC00023254-02
NCGC00023254-04
NCGC00023254-05
NCGC00023254-06
NCGC00023254-07
NCGC00023254-08
NCGC00023254-09
NCGC00023254-10
NCGC00257146-01
NCGC00259497-01
NCGC00261706-01
NCI-C56360
Neurosyn
NINDS_000324
NSC 41701
NSC-41701
NSC-757291
NSC41701
NSC757291
Opera_ID_1083
P 7295
P1906
Pharmakon1600-01500501
Pms Primidone
Prestwick0_000933
Prestwick1_000933
Prestwick2_000933
Prestwick3_000933
Prilepsin
Primacione
Primaclone
Primacone
Primakton
Primidon
Primidon Holsten
Primidona
Primidona [INN-Spanish]
Primidone (JP15/USP/INN)
Primidone (JP17/USP/INN)
Primidone (Mysoline)
Primidone (primaclone)
Primidone [USAN:INN:BAN:JAN]
Primidone [USP:INN:BAN:JAN]
Primidone for peak identification, European Pharmacopoeia (EP) Reference Standard
Primidone Methanol Solution
Primidone, analytical standard
Primidone, European Pharmacopoeia (EP) Reference Standard
Primidone, United States Pharmacopeia (USP) Reference Standard
Primidone(Mysoline)
Primidonum
Primidonum [INN-Latin]
Primoline
Prysoline
Prysoline (TN)
Pyrimidone ''Medi-pets''
Pyrimidone 'Medi-pets'
Pyrimidone "Medi-pets"
Pyrimidone (Medi-pets)
Pyrimidone Medi-pets
Resimatil
Resimatil (TN)
Roe 101
s1965
SAM002554925
Sanofi-Synthelabo Brand of Primidone
SBB017254
SBI-0050994.P004
SC-18998
SCHEMBL34221
Sertan
Sertan (TN)
SMP1_000135
SMR000058501
SPBio_001325
SPBio_003035
Spectrum_000832
SPECTRUM1500501
Spectrum2_001293
Spectrum3_000553
Spectrum4_000485
Spectrum5_001144
SR-01000003162
SR-01000003162-2
ST076725
Tocris-0830
Tox21_110238
Tox21_110238_1
Tox21_201948
Tox21_303194
Tox21_501021
TR-003816
UNII-13AFD7670Q
WLN: T6MV DVMTJ C2 CR
Xcel Brand of Primidone
ZB000454
Zeneca Brand of Primidone
ZINC1979

US Patents and Regulatory Information for primidone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Ltd PRIMIDONE primidone TABLET;ORAL 040862-002 Oct 3, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Hikma Intl Pharms PRIMIDONE primidone TABLET;ORAL 040667-002 Jul 27, 2006 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Valeant MYSOLINE primidone TABLET;ORAL 009170-002 Approved Prior to Jan 1, 1982 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lannett PRIMIDONE primidone TABLET;ORAL 084903-001 Approved Prior to Jan 1, 1982 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Lannett PRIMIDONE primidone TABLET;ORAL 084903-002 May 24, 2001 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Impax Labs PRIMIDONE primidone TABLET;ORAL 040717-001 Feb 12, 2008 DISCN No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Anda Repository PRIMIDONE primidone TABLET;ORAL 040626-002 Sep 29, 2005 AB RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Mallinckrodt
Citi
Cipla
Boehringer Ingelheim
Johnson and Johnson
Merck
Cerilliant
Moodys

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