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Last Updated: December 12, 2019

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BICALUTAMIDE Drug Profile

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When do Bicalutamide patents expire, and when can generic versions of Bicalutamide launch?

Bicalutamide is a drug marketed by Accord Hlthcare, Apotex Inc, Fresenius Kabi Usa, Kenton, Kudco Ireland, Mylan, Roxane, Sandoz, Sun Pharm, Synthon Pharms, Teva, Watson Labs Teva, and Zydus Pharms Usa Inc. and is included in thirteen NDAs.

The generic ingredient in BICALUTAMIDE is bicalutamide. There are twenty-nine drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the bicalutamide profile page.

US ANDA Litigation and Generic Entry Outlook for Bicalutamide

A generic version of BICALUTAMIDE was launched as bicalutamide by ACCORD HLTHCARE on December 12th, 2019.

Drug patent expirations by year for BICALUTAMIDE
Drug Prices for BICALUTAMIDE

See drug prices for BICALUTAMIDE

Recent Clinical Trials for BICALUTAMIDE

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

SponsorPhase
Bristol-Myers SquibbPhase 2
Providence Health & ServicesPhase 2
BayerPhase 2

See all BICALUTAMIDE clinical trials

Pharmacology for BICALUTAMIDE
Synonyms for BICALUTAMIDE
(+-)-4'-Cyano-alpha,alpha,alpha-trifluoro-3-((p-fluorophenyl)sulfonyl)-2-methyl-m-lactotoluidide
357B065
4'-cyano-3-[(4- fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-3'-trifluoromethylpropionanilide
4'-cyano-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-3'-trifluoromethylpropionanilide
90357-06-5
A803039
AB0008136
AB00639963_10
AB00639963-06
AB00639963-08
AB00639963-09
AC-4232
AC1L1DJE
ACT06291
AK544272
AKOS015895073
AN-582
AOB5596
API0001710
AT-9158
B3206
BC204097
BCP02110
BCP9000408
BCPP000337
BDBM18525
bicalutamida
Bicalutamide - Casodex
Bicalutamide (Casodex)
Bicalutamide (CDX)
Bicalutamide (CDX), >=98% (HPLC), powder
Bicalutamide (JAN/USP/INN)
Bicalutamide [USAN:INN:BAN]
Bicalutamide [USAN:USP:INN:BAN]
Bicalutamide for system suitability, European Pharmacopoeia (EP) Reference Standard
Bicalutamide, 97%
Bicalutamide, British Pharmacopoeia (BP) Reference Standard
Bicalutamide, European Pharmacopoeia (EP) Reference Standard
Bicalutamide, Pharmaceutical Secondary Standard; Certified Reference Material
Bicalutamide, United States Pharmacopeia (USP) Reference Standard
Bicalutamide(Casodex)
bicalutamidum
Bicalutamine
BRD-A29485665-001-03-7
BRN 5364666
C08160
C18H14F4N2O4S
Calutide
Casodex
Casodex (TN)
CB0180
CCG-100951
CCG-220876
CCG-222330
CCRIS 8728
CHEBI:91617
CHEMBL409
Cosudex
CPD000466329
CS-1296
D00961
DB01128
DTXSID2022678
EX-A962
FT-0080576
FT-0618286
GTPL2863
HMS2051B13
HMS2089N12
HMS2232H03
HMS3263M13
HMS3372K05
HMS3393B13
HMS3654K18
HMS3714P13
HSDB 7655
HY-14249
I06-0475
I06-0480
ICI 176,334
ICI 176334
ICI-176334
J10442
Kalumid
KS-00000XEI
KS-1161
LKJPYSCBVHEWIU-UHFFFAOYSA-N
LP01026
LS-119125
MFCD00869971
MLS000759437
MLS001424047
MolPort-003-845-034
MolPort-006-808-679
N-(4-cyano-3-(trifluoromethyl)phenyl)
N-(4-cyano-3-(trifluoromethyl)phenyl)-3-((4-fluorophenyl)sulfonyl)-2-hydroxy-2-methylpropanamide
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methyl-propanamide
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-hydroxy-2-methylpropanamide
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-(4-fluorophenyl)sulfonyl-2-methyl-2-oxidanyl-propanamide
N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorobenzene)sulfonyl]-2-hydroxy-2-methylpropanamide
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropanamide
N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methylpropionamide
N-[4-cyano-3-trifluoromethyl-phenyl]-3-[4-fluorophenyl-sulfonyl]-2-hydroxy-2-methyl-propionamide
NC00201
NCGC00167977-01
NCGC00167977-02
NCGC00167977-03
NCGC00167977-09
NCGC00261711-01
NSC-722665
NSC-759816
NSC722665
NSC759816
Pharmakon1600-01504827
PRO113
Propanamide, N-(4-cyano-3-(trifluoromethyl)phenyl)-3-((4-fluorophenyl)sulfonyl)-2-hydroxy-2-methyl-, (+-)-
Propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-
propanamide, N-[4-cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfonyl]-2-hydroxy-2-methyl-,(+-)
PubChem18237
Raffolutil
s1190
SAM001246612
SB17301
SC-17332
SCHEMBL3611
SMR000466329
SR-01000759410
SR-01000759410-4
SR-01000759410-5
SW197581-4
TL8005814
Tox21_501026

US Patents and Regulatory Information for BICALUTAMIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare BICALUTAMIDE bicalutamide TABLET;ORAL 078917-001 Jul 6, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Roxane BICALUTAMIDE bicalutamide TABLET;ORAL 078285-001 Mar 24, 2011 DISCN No No   Start Trial   Start Trial   Start Trial
Kenton BICALUTAMIDE bicalutamide TABLET;ORAL 091011-001 Jun 10, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Watson Labs Teva BICALUTAMIDE bicalutamide TABLET;ORAL 078634-001 Aug 28, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz BICALUTAMIDE bicalutamide TABLET;ORAL 078575-001 Jul 6, 2009 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc BICALUTAMIDE bicalutamide TABLET;ORAL 200274-001 May 21, 2015 AB RX 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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