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Last Updated: April 10, 2020

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CLOZAPINE Drug Profile


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Which patents cover Clozapine, and when can generic versions of Clozapine launch?

Clozapine is a drug marketed by Barr Labs Inc, Mylan, Teva Pharms Usa, Accord Hlthcare, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Mayne Pharma, Par Pharm, Sandoz, Sun Pharm Inds Inc, and Zydus Pharms. and is included in thirteen NDAs.

The generic ingredient in CLOZAPINE is clozapine. There are thirteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the clozapine profile page.

US ANDA Litigation and Generic Entry Outlook for Clozapine

A generic version of CLOZAPINE was approved as clozapine by IVAX SUB TEVA PHARMS on November 26th, 1997.

  Start Trial

Drug patent expirations by year for CLOZAPINE
Drug Prices for CLOZAPINE

See drug prices for CLOZAPINE

Recent Clinical Trials for CLOZAPINE

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

SponsorPhase
University Hospital, Strasbourg, FrancePhase 2
AstraZenecaEarly Phase 1
King's College Hospital NHS TrustEarly Phase 1

See all CLOZAPINE clinical trials

Recent Litigation for CLOZAPINE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Purdue Pharmaceutical v. Actavis Elizabeth LLC2015-05-13
CIMA Labs Inc. v. Barr Laboratories Inc.2008-08-21
Cephalon Inc. v. Barr Pharmaceuticals Inc.2008-07-22

See all CLOZAPINE litigation

Pharmacology for CLOZAPINE
Medical Subject Heading (MeSH) Categories for CLOZAPINE
Synonyms for CLOZAPINE
(E)-8-chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine
1333667-72-3
3-chloro-6-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine
3-chloro-6-(4-methylpiperazin-1-yl)-11H-benzo[b][1,4]benzodiazepine
3-chloro-6-(4-methylpiperazin-1-yl)-5H-benzo[b][1,4]benzodiazepine
3-Hydroxy-2-phenyl-propionic acid 8-methyl-8-aza-bicyclo[3.2.1]oct-3-yl ester
5786-21-0
5H-Dibenzo(b,e)(1,4)diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-
5H-Dibenzo[b,e][1,4]diazepine, 8-chloro-11-(4-methyl-1-piperazinyl)-
6-chloro-10-(4-methylpiperazin-1-yl)-2,9-diazatricyclo[9.4.0.0^{3,8}]pentadeca-1,3(8),4,6,10,12,14-heptaene
6-chloro-10-(4-methylpiperazin-1-yl)-2,9-diazatricyclo[9.4.0.0(3),]pentadeca-1,3,5,7,10,12,14-heptaene
6-chloro-10-(4-methylpiperazin-1-yl)-2,9-diazatricyclo[9.4.0.03,8]pentadeca-1(11),3,5,7,9,12,14-heptaene
786C210
8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo(b,e)(1,4)diazepine
8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]-diazepine
8-Chloro-11-(4-methyl-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine
8-chloro-11-(4-methyl-piperazin-1-yl)-10H-dibenzo[b,e][1,4]diazepine
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine (Clozapine)
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine( Clozepine )
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine(Ciozapine)
8-Chloro-11-(4-methyl-piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine(Clopazine)
8-Chloro-11-(4-methyl)-1-piperazinyl)-5H-dibenzo[b,e][1,4]diazepine
8-chloro-11-(4-methylpiperazin-1-yl)-10H-dibenzo[b,e][1,4]diazepine
8-chloro-11-(4-methylpiperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine
8-Chloro-11-(4-methylpiperazino)-5H-dibenzo[b,e][1,4]diazepine
A10236
AB00052158_15
AB00052158_16
AB00052158-13
AB00052158-14
AB0013069
AB1009321
AKOS005064444
AKOS026749900
ANW-42470
AOB5635
Asaleptin
Azaleptine
BCP25196
BDBM22869
BDBM50001884
BG0154
Bio1_000436
Bio1_000925
Bio1_001414
Bio2_000310
Bio2_000790
BRD-K37289225-001-09-1
BRD-K37289225-001-23-2
BRN 0764984
C 6305
C-36335
C06924
C18H19ClN4
CAS-5786-21-0
CC0176
CCG-39881
CCRIS 9171
CHEBI:3766
CHEBI:92657
CHEMBL42
Clorazil
Clozapin
Clozapina
Clozapina [INN-Spanish]
Clozapine (Clozaril)
Clozapine (JAN/USP/INN)
Clozapine [USAN:INN:BAN]
Clozapine [USAN:USP:INN:BAN]
Clozapine 1.0 mg/ml in Acetonitrile
Clozapine for peak identification, European Pharmacopoeia (EP) Reference Standard
Clozapine resolution mixture
Clozapine Resolution Mixture, United States Pharmacopeia (USP) Reference Standard
Clozapine solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
CLOZAPINE, 8-CHLORO-11-(4-METHYL-PIPERAZIN-1-YL)-5H-DIBENZO[B,E][1,4]DIAZEPINE
Clozapine, British Pharmacopoeia (BP) Reference Standard
Clozapine, drug standard, 1.0 mg/mL in methanol
Clozapine, European Pharmacopoeia (EP) Reference Standard
Clozapine, solid
Clozapine, United States Pharmacopeia (USP) Reference Standard
Clozapine(Clozaril)
Clozapinum
Clozapinum [INN-Latin]
CLOZARIL
Clozaril (TN)
CPD000058365
CS-0644
CTK6I2968
D-107
D00283
DB-053121
DB00363
DivK1c_000343
DSSTox_CID_2855
DSSTox_GSID_22855
DSSTox_RID_76759
DTXSID5022855
EINECS 227-313-7
EN300-52510
EU-0100276
Fazaclo
Fazaclo ODT
FT-0082373
FT-0600382
GP7633
GTPL38
H482
HF 1854
HF-1854
HMS1361P12
HMS1569E21
HMS1791P12
HMS1921C16
HMS1989P12
HMS2089L13
HMS2092I16
HMS2096E21
HMS2235E19
HMS3259J17
HMS3260H14
HMS3266A10
HMS3371H05
HMS3402P12
HMS3414F09
HMS3657E15
HMS3678F09
HMS3713E21
HMS3742K03
HMS501B05
HSDB 6478
HY-14539
Iprox
J60AR2IKIC
KBio1_000343
KBio2_000310
KBio2_000599
KBio2_002878
KBio2_003167
KBio2_005446
KBio2_005735
KBio3_000619
KBio3_000620
KBio3_002979
KBioGR_000310
KBioGR_001336
KBioSS_000310
KBioSS_000599
KS-1166
L000195
L013417
Leponex
Lepotex
LEX-123
Lopac-C-6305
LP00276
LS-60881
LX 100-129
MCULE-3665900006
MFCD00153785
MLS000028472
MLS001077282
NC00667
NCGC00015254-01
NCGC00015254-02
NCGC00015254-03
NCGC00015254-04
NCGC00015254-05
NCGC00015254-06
NCGC00015254-07
NCGC00015254-08
NCGC00015254-09
NCGC00015254-10
NCGC00015254-11
NCGC00015254-12
NCGC00015254-13
NCGC00015254-14
NCGC00015254-15
NCGC00015254-16
NCGC00015254-17
NCGC00015254-18
NCGC00015254-20
NCGC00022902-02
NCGC00022902-04
NCGC00022902-05
NCGC00022902-06
NCGC00022902-07
NCGC00022902-08
NCGC00022902-09
NCGC00022902-10
NCGC00022902-11
NCGC00022902-12
NCGC00022902-13
NCGC00188978-01
NCGC00260961-01
NINDS_000343
NSC-757429
NSC757429
Opera_ID_482
Pharmakon1600-01500685
Prestwick_693
Prestwick0_000350
Prestwick1_000350
Q221361
QZUDBNBUXVUHMW-UHFFFAOYSA-N
REGID_for_CID_2818
s2459
SAM002548976
SAM002589962
SBI-0050264.P004
SC-12183
SC-26976
SCHEMBL33323
SCHEMBL8397
SMR000058365
SPBio_000798
SPBio_002340
Spectrum_000139
SPECTRUM1500685
Spectrum2_000919
Spectrum3_001828
Spectrum4_000898
SR-01000000096
SR-01000000096-2
SR-01000000096-4
SR-01000000096-5
SR-01000000096-8
SW220247-1
TC-063560
Tocris-0444
Tox21_110113
Tox21_110113_1
Tox21_500276
UNII-J60AR2IKIC
Versacloz
W-105432
W-2845
W-801
Z1245633277
ZINC19796155
ZINC3872123
Paragraph IV (Patent) Challenges for CLOZAPINE
Tradename Dosage Ingredient NDA Submissiondate
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-18
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2011-04-08
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2008-06-05
FAZACLO ODT TABLET, ORALLY DISINTEGRATING;ORAL clozapine 021590 2008-04-28

US Patents and Regulatory Information for CLOZAPINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Zydus Pharms CLOZAPINE clozapine TABLET;ORAL 209480-004 Dec 6, 2017 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz CLOZAPINE clozapine TABLET;ORAL 074546-001 Aug 30, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan CLOZAPINE clozapine TABLET;ORAL 075417-002 May 27, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz CLOZAPINE clozapine TABLET;ORAL 074546-002 Aug 30, 1996 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan CLOZAPINE clozapine TABLET;ORAL 075417-005 Apr 15, 2010 AB RX No No   Start Trial   Start Trial   Start Trial
Barr Labs Inc CLOZAPINE clozapine TABLET, ORALLY DISINTEGRATING;ORAL 090308-003 Apr 9, 2018 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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Serving leading biopharmaceutical companies globally:

McKinsey
Mallinckrodt
Colorcon
Express Scripts
Johnson and Johnson
Merck

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