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Last Updated: December 9, 2019

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Nilutamide - Generic Drug Details

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

Nilutamide is the generic ingredient in two branded drugs marketed by Concordia and Ani Pharms Inc, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for nilutamide. Three suppliers are listed for this compound.

Recent Clinical Trials for nilutamide

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

SponsorPhase
Dr. Han Xu, President/CEO / PD / PI / Monitor / IRB ChairPhase 2/Phase 3
PPDPhase 2/Phase 3
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all nilutamide clinical trials

Pharmacology for nilutamide
Synonyms for nilutamide
1-(3-'trifluoromethyl-4'-nitrophenyl)-4,4-dimethyl-imidazoline-2,5-dione
1-(3-trifluoromethyl-4-nitro-phenyl)-4,4-dimethyl imidazolidine-2,5-dione
1-(3-trifluoromethyl-4-nitro-phenyl)-4,4-dimethyl-imidazolidine-2,5-dione
1-(3-trifluoromethyl-4-nitro-phenyl)-4,4-dimethyl-imidazoline-2,5-dione
1-(3-trifluoromethyl-4-nitrophenyl)-4,4-dimethyl-imidazoline-2,5-dione
1-(3'-trifluoromethyl-4'-nitrophenyl)-4,4-dimethyl-imidazoline-2,5-dione
1-(3'-Trifluoromethyl-4'-nitrophenyl)-4,4-dimethylimidazolidine-2,5-dione
1-(3'-trifluoromethyl-4'-nitrophenyl)4,4-dimethyl-imidazoline-2,5-dione
1-(3'-trifluoromethyl-4'nitrophenyl)-4,4-dimethyl-imidazoline-2,5-dione
1-(3'trifluoromethyl-4'-nitropheyl)-4,4-dimethyl-imidazoline-2,5-dione
2,4-IMIDAZOLIDINEDIONE, 5,5-DIMETHYL-3-(4-NITRO-3-(TRIFLUOROMETHYL)PHENYL)-
3-(3-(trifluoromethyl)-4-nitrophenyl)-5,5-dimethylimidazolidine-2,4-dione
4CA-0906
5,5-Dimethyl-3-(4-nitro-3-(trifluoromethyl)-phenyl)imidazolidine-2,4-dione
5,5-dimethyl-3-(4-nitro-3-(trifluoromethyl)phenyl)- 2,4-imidazolidinedione
5,5-Dimethyl-3-(4-nitro-3-(trifluoromethyl)phenyl)-2,4-imidazolidinedione
5,5-dimethyl-3-(4-nitro-3-(trifluoromethyl)phenyl)imidazolidine-2,4-dione
5,5-Dimethyl-3-(alpha,alpha,alpha-trifluoro-4-nitro-m-tolyl)hydantoin
5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-1,3-diazolidine-2,4-dione
5,5-Dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-2,4-imidazolidinedione
5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]-imidazolidine-2,4-dione
5,5-dimethyl-3-[4-nitro-3-(trifluoromethyl)phenyl]imidazolidine-2,4-dione
51G6I8B902
612N500
63612-50-0
A834440
AB00053180
AB00053180_07
AB0013969
AC-5260
AC1L1IAG
AJ-46401
AKOS005565152
AKOS025147305
AN-11150
Anandron
ANW-58327
AS-14123
BCP26617
BCP9000990
BCPP000148
BDBM50135912
BIDD:GT0683
BIDD:PXR0177
BPBio1_000920
BRD-K23566484-001-05-2
BRD-K23566484-001-09-4
BRN 0841906
BSPBio_000836
BSPBio_003325
C08164
C12H10F3N3O4
CAS-63612-50-0
CCG-39427
CHEBI:7573
CHEMBL1274
CTK8B7740
D00965
DB00665
DivK1c_006998
DSSTox_CID_14165
DSSTox_GSID_34165
DSSTox_RID_79118
DTXSID3034165
EU-0100879
FT-0080574
FT-0630740
GTPL2864
HMS1570J18
HMS1922F03
HMS2093A10
HMS2097J18
HMS2230E03
HMS3262P19
HMS3268C18
HMS3369I02
HMS3714J18
I14-2740
K002
KB-58335
KBio1_001942
KBio2_002105
KBio2_004673
KBio2_007241
KBio3_002545
KBioGR_001100
KBioSS_002105
L000759
Lopac-N-8534
Lopac0_000879
LP00879
LS-79181
MCULE-3215206804
MFCD00864670
MLS002154066
MolPort-003-666-533
MolPort-005-975-300
N 8534
NCGC00015754-01
NCGC00015754-02
NCGC00015754-03
NCGC00015754-04
NCGC00015754-05
NCGC00015754-06
NCGC00015754-07
NCGC00015754-08
NCGC00015754-09
NCGC00015754-10
NCGC00015754-11
NCGC00015754-12
NCGC00015754-15
NCGC00015754-16
NCGC00025280-01
NCGC00025280-02
NCGC00025280-03
NCGC00025280-04
NCGC00025280-05
NCGC00025280-06
NCGC00025280-07
NCGC00025280-08
NCGC00255271-01
NCGC00261564-01
Nilandron
Nilandron (TN)
Nilandrone
Nilutamida
Nilutamida [Spanish]
Nilutamide (USAN/INN)
Nilutamide [USAN:BAN:INN]
Nilutamide [USAN:INN:BAN]
Nilutamide, European Pharmacopoeia (EP) Reference Standard
Nilutamide, solid
Nilutamidum
Nilutamidum [Latin]
NSC-758683
NSC758683
Pharmakon1600-01504152
Prestwick0_000928
Prestwick1_000928
Prestwick2_000928
Prestwick3_000928
PubChem19359
RU 23908
RU 23908-10
RU-23908
SB19036
SBB067297
SBI-0050854.P003
SC-74493
SCHEMBL12670
SMR001233381
SPBio_002125
SPBio_003015
SpecPlus_000902
Spectrum_001625
SPECTRUM1504152
Spectrum2_001973
Spectrum3_001633
Spectrum4_000600
Spectrum5_001512
SR-01000076034
SR-01000076034-1
SR-01000076034-3
SR-01000076034-5
SR-01000076034-6
SR-01000076034-9
ST075550
STK633161
TC-030602
Tocris-1759
Tox21 110213
Tox21_110213
Tox21_110213_1
Tox21_301589
Tox21_500879
UNII-51G6I8B902
XWXYUMMDTVBTOU-UHFFFAOYSA-N
Z2417927201
ZINC3874498

US Patents and Regulatory Information for nilutamide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Concordia NILANDRON nilutamide TABLET;ORAL 020169-002 Apr 30, 1999 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NILUTAMIDE nilutamide TABLET;ORAL 207631-001 Jul 15, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Concordia NILANDRON nilutamide TABLET;ORAL 020169-001 Sep 19, 1996 DISCN No No   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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Harvard Business School
Dow
Colorcon
Moodys
AstraZeneca

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