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Last Updated: December 9, 2019

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Ziprasidone hydrochloride - Generic Drug Details

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What are the generic drug sources for ziprasidone hydrochloride and what is the scope of patent protection?

Ziprasidone hydrochloride is the generic ingredient in two branded drugs marketed by Pfizer, Apotex Inc, Aurobindo Pharma Ltd, Cadila, Dr Reddys Labs Inc, Lupin Pharms, Macleods Pharms Ltd, Mylan, Sandoz Inc, Wockhardt Ltd, and Pfizer Inc, and is included in eleven NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Ziprasidone hydrochloride has one hundred and seventeen patent family members in fifty-three countries.

There are twenty-three drug master file entries for ziprasidone hydrochloride. Twenty-four suppliers are listed for this compound.

Summary for ziprasidone hydrochloride
Recent Clinical Trials for ziprasidone hydrochloride

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

SponsorPhase
University of ArizonaPhase 1
Sidney R. Baer, Jr. FoundationPhase 1
Astellas Pharma Global Development, Inc.Phase 2

See all ziprasidone hydrochloride clinical trials

Pharmacology for ziprasidone hydrochloride
Synonyms for ziprasidone hydrochloride
122883-93-6
122883-93-6,138982-67-9(ClH.H2O),146939-27-7(freebase)
138982-67-9
138982-67-9 (hydrochloride monohydrate)
146939-27-7
146939-27-7 (Parent)
216X081ORU
2H-Indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-
2H-Indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, monohydrochloride
2H-Indol-2-one, 5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-, monohydrochloride, monohydrate
2H-Indol-2-one, 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-
2H-Indol-2-one, 5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-, hydrochloride (1:1)
2H-Indol-2-one,5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl_ethyl)-6-chloro-1,3-dihydro-monohydrochloride,monohydrate
4169AH
4770-EP2272537A2
4770-EP2272841A1
4770-EP2275420A1
4770-EP2280010A2
4770-EP2298731A1
4770-EP2298776A1
4770-EP2301936A1
4770-EP2308875A1
4770-EP2316836A1
4CH-010458
4CH-021473
5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)-ethyl)-6-chloro-1,3-dihydro-2H-indol-2-one
5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-2h-indol-2-one
5-(2-(4-(1,2-benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-1,3-dihydro-2H-indole-2-one
5-(2-(4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl)ethyl)-6-chloro-2-indolinone monohydrochloride, monohydrate
5-(2-(4-(benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one
5-(2-(4-(BENZO[D]ISOTHIAZOL-3-YL)PIPERAZIN-1-YL)ETHYL)-6-CHLOROINDOLIN-2-ONE HCL
5-(2-(4-(Benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one hydrochloride
5-(2-(4-(Benzo[d]isothiazol-3-yl)piperazin-1-yl)ethyl)-6-chloroindolin-2-one hydrochloride hydrate
5-[2-(4-Benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one
5-[2-(4-Benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one (Ziprasidone)
5-[2-(4-Benzo[d]isothiazol-3-yl-piperazin-1-yl)-ethyl]-6-chloro-1,3-dihydro-indol-2-one(Norastemizole)
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1, 3-dihydro-2h-indol-2-one hydrochloride
5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one
5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one hydrochloride
5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one hydrochloride monohydrate
5-[2-[4-(1,2-Benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one Hydrochloride Monohydrate, CP-88059-1
5-[2-[4-(1,2-benzisothiazol-3yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2h-indol-2-one hydrochlor
5-[2-[4-(1,2-Benzisothiazol-3yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one hydrochloride
5-[2-[4-(1,2-benzothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydroindol-2-one
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloranyl-1,3-dihydroindol-2-one
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one hydrate hydrochloride
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one hydrochloride
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one;hydrate;hydrochloride
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-indolin-2-one
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-indolin-2-one hydrate hydrochloride
5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-indolin-2-one hydrochloride
5-{2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl}-6-chlor-1,3-dihydro-2h-indol-2-onhydrochlorid
5-{2-[4-(1,2-benzisothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-1,3-dihydro-2H-indol-2-one
5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-1,3-dihydro-2H-indol-2-one
5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-2,3-dihydro-1H-indol-2-one
5-{2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl}-6-chloro-2,3-dihydro-1H-indol-2-one hydrochloride
6UKA5VEJ6X
883Z936
939Z277
982Z679
A808568
AB0013070
AB00639925_05
AB00639925_06
AB00639925-02
AB00639925-04
AB2000113
AC-23360
AC-26998
AC-7053
AC1L1U24
AC1L1U27
AC1L561V
AC1Q3ESU
AC1Q3ESV
AJ-23401
AK-33211
AKOS015848366
AKOS015900383
AKOS015961662
AM90310
AN-16930
AN-32764
AN-9382
ANW-50099
ANW-58715
API0004647
API0004648
API0004649
AS-16359
AX8212731
BC207663
BC643069
BDBM50048803
BIDD:GT0042
BN0799
BR-33211
C-35605
C07568
C21H21ClN4OS
C21H21ClN4OS.HCl
C21H21ClN4OS.HCl[H2O]
C21H22Cl2N4OS
CAS-146939-27-7
CCG-220561
CCG-222329
CHEBI:10119
CHEBI:32314
CHEMBL1375743
CHEMBL1712
CHEMBL708
CP 88-059-01
CP 88,059-1
CP 88059
CP 88059-01
CP 88059-1
CP 88059;CP-88059;CP88059
CP-88,059
CP-88,059-01
CP-88,059-1
CP-88059
CP-88059-01
CP-88059-1
CP-88059-27
CP-880591
CP-8805927
CPD000466328
CS-1071
CS-1198
CS-1887
CTK8B5786
CTK8B7827
CZ0013
CZ0015
D01939
D08687
DB00246
DSSTox_CID_3753
DSSTox_GSID_23753
DSSTox_RID_77186
DTXSID00153762
DTXSID00160855
DTXSID4023753
FT-0600387
FT-0654208
FT-0655916
Geodon
Geodon (TN)
Geodon Hydrochloride Hydrate
Geodon Oral
Geodon;Zeldox
GP6084
GTPL59
H485
HSDB 7745
HY-14542
HY-14542A
HY-17407
I06-0078
I06-078
I14-0766
J-007206
JAL53626GG
KB-243244
KS-1219
L000659
LP01025
LS-172544
LS-173039
LS-83744
ME-2112
MFCD00921885
MLS000759435
MLS006010221
MolPort-003-850-885
MolPort-003-986-316
MolPort-005-934-812
MVWVFYHBGMAFLY-UHFFFAOYSA-N
NCGC00186050-01
NCGC00261710-01
NCGC00263539-01
NCGC00263539-03
NCGC00263539-05
NZDBKBRIBJLNNT-UHFFFAOYSA-N
RTR-031719
S-2230
s1444
SAM001246607
SC-22049
SC-94640
SCHEMBL122875
SCHEMBL122876
SCHEMBL28028
SMR000466328
SMR002204092
SR-01000759387
SR-01000759387-2
ST24023714
ST24044165
SW199027-2
SYN3019
TC-138844
TL8000613
TL8000889
Tox21_112194
Tox21_112194_1
Tox21_113525
Tox21_501025
TR-031719
TRA0084802
UNII-216X081ORU
UNII-6UKA5VEJ6X
UNII-JAL53626GG
VU0286234-2
W-5149
X9542
ZCBZSCBNOOIHFP-UHFFFAOYSA-N
Zeldox
ZINC538550
Zipradon (TN)
ziprasidona
Ziprasidone
Ziprasidone (hydrochloride monohydrate)
Ziprasidone (hydrochloride)
Ziprasidone (INN)
Ziprasidone [INN:BAN]
Ziprasidone for system suitability 1, European Pharmacopoeia (EP) Reference Standard
Ziprasidone for system suitability 2, European Pharmacopoeia (EP) Reference Standard
Ziprasidone HCl
Ziprasidone HCl hydrate
Ziprasidone HCl monohydrate
Ziprasidone hydrochloride (USAN)
Ziprasidone hydrochloride [USAN:USP]
Ziprasidone hydrochloride [USAN]
ZIPRASIDONE HYDROCHLORIDE HYDRATE
Ziprasidone hydrochloride hydrate (JAN)
Ziprasidone hydrochloride monohydrate
Ziprasidone Hydrochloride Monohydrate 1.0 mg/ml in Methanol (as anhydrous free base)
Ziprasidone hydrochloride monohydrate, >=98% (HPLC), solid
Ziprasidone hydrochloride monohydrate, European Pharmacopoeia (EP) Reference Standard
Ziprasidone hydrochloride solution, 1.0 mg/mL in methanol, certified reference material, ampule of 1 mL
ziprasidone hydrochloride, monohydrate
Ziprasidone hydrochloride, United States Pharmacopeia (USP) Reference Standard
Ziprasidone mesylate trihydrate
Ziprasidone solution, 1.0 mg/mL in 1,2-dimethoxyethane, ampule of 1 mL, certified reference material
Ziprasidone, HCl
Ziprasidone.HCl
ziprasidonum
ziprazidone
ZLA0004
zlchem 4
Paragraph IV (Patent) Challenges for ZIPRASIDONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
GEODON CAPSULE;ORAL ziprasidone hydrochloride 020825 2005-02-07

US Patents and Regulatory Information for ziprasidone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 202395-004 Oct 10, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Sandoz Inc ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077562-004 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Wockhardt Ltd ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 090348-004 Sep 5, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sandoz Inc ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077562-001 Jun 1, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Apotex Inc ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 077561-004 Mar 2, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd ZIPRASIDONE HYDROCHLORIDE ziprasidone hydrochloride CAPSULE;ORAL 204117-002 Dec 27, 2016 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

Expired US Patents for ziprasidone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Inc GEODON ziprasidone hydrochloride SUSPENSION;ORAL 021483-001 Mar 29, 2006   Start Trial   Start Trial
Pfizer Inc GEODON ziprasidone hydrochloride SUSPENSION;ORAL 021483-001 Mar 29, 2006   Start Trial   Start Trial
Pfizer GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-002 Feb 5, 2001   Start Trial   Start Trial
Pfizer GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-004 Feb 5, 2001   Start Trial   Start Trial
Pfizer GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-003 Feb 5, 2001   Start Trial   Start Trial
Pfizer GEODON ziprasidone hydrochloride CAPSULE;ORAL 020825-001 Feb 5, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.