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Generated: April 26, 2018

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Aripiprazole - Generic Drug Details

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

Aripiprazole
is the generic ingredient in five branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Silarx Pharms Inc, Alembic Pharms Ltd, Orchid Hlthcare, Accord Hlthcare, Ajanta Pharma Ltd, Aurobindo Pharma Ltd, Hetero Labs Ltd V, Macleods Pharms Ltd, Prinston Inc, Santos Biotech, Sciegen Pharms Inc, Teva Pharms Usa, Torrent Pharms Ltd, and Alkermes Inc, and is included in twenty-eight NDAs. There are fifty-four patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Aripiprazole has eight hundred and six patent family members in fifty-four countries.

There are forty-five drug master file entries for aripiprazole. Forty-one suppliers are listed for this compound. There are four tentative approvals for this compound.
Pharmacology for aripiprazole
Medical Subject Heading (MeSH) Categories for aripiprazole
Synonyms for aripiprazole
129722-12-9
2(1H)-Quinolinone, 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-
2(1H)-Quinolinone, 7-[4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-
24-29-3
4811-EP2269990A1
4811-EP2272841A1
4811-EP2298731A1
4811-EP2298776A1
4811-EP2301936A1
7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydro-2(1H)-quinolinone
7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril
7-(4-(4-(2,3-Dichlorophenyl)-1-piperazinyl)butyloxy)-3,4-dihydro-2(1H)-quinolinone
7-(4-(4-(2,3-DICHLOROPHENYL)PIPERAZIN-1-YL)BUTOXY)-3,4-DIHYDROQUINOLIN-2(1H)-ONE
7-(4-[4-(2,3-DICHLORO-PHENYL)-PIPERAZIN-1-YL]-BUTOXY)-3,4-DIHYDRO-1H-QUINOLIN-2-ONE
7-(4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy)-3,4-dihydrocarbostyril
7-(4-[4-(2,3-DICHLOROPHENYL)PIPERAZIN-1-YL]BUTOXY)-1,2,3,4-TETRAHYDROQUINOLIN-2-ONE
7-(4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy)-3,4-dihydroquinolin-2(1H)-one
7-[4-(4-(2,3-Dichlorophenyl)piperazin-1-yl)butoxy]-3,4-dihydro-2(1H)-quinolinone
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydro-2(1H)-quinolinone
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril
7-[4-[4-(2,3-Dichlorophenyl)-1-piperazinyl]butoxy]-3,4-dihydrocarbostyril; 7-{4-[4-(2,3-Dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one
7-[4-[4-(2,3-Dichlorophenyl)-1-Piperazinyl]Butoxy]3,4-Dihydro-2(1H)-Quinolinone
7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-1H-quinolin-2-one
7-[4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy]-3,4-dihydro-quinolin-2(1H)-one
7-{4-[-4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril
7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3, 4-dihydrocarbostyril
7-{4-[4-(2,3-dichlorophenyl)-1-piperazinyl]butoxy}-3,4-dihydrocarbostyril
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-1,2,3,4-tetrahydroquinolin-2-one
7-{4-[4-(2,3-dichlorophenyl)piperazin-1-yl]butoxy}-3,4-dihydroquinolin-2(1H)-one
7-{4-[4-(2,3-dichlorophenyl)piperazino]butoxy}-3,4-dihydro-2(1H)-quinolinone
722A129
82VFR53I78
A19454
AB0008434
AB00639935_10
AB00639935_11
AB00639935-09
AB07660
AB1006698
Abilify
Abilify (TN)
Abilify Digital
Abilify Discmelt
Abilify Maintena
Abilify Maintena Kit
Abilify MyCite
Abilify OD
Abilitat
AC-1554
AC1L1TXZ
AC1Q3T38
ACMC-20emtv
ACT03221
AJ-32089
AK-46736
AKOS005558247
ALKS-9070
ALKS-9072
ALKS9070/ALKS9072
AM20090766
AN-902
AOB5922
aripiprazol
Aripiprazole (Abilify)
Aripiprazole (JAN/USAN/INN)
Aripiprazole [USAN:INN:BAN]
Aripiprazole [USAN]
Aripiprazole 1.0 mg/ml in Acetonitrile
Aripiprazole Depot
Aripiprazole hydrate
Aripiprazole solution, 1.0 mg/mL (1:1 Methanol/Water with 1% 1N HCl), ampule of 1 mL, certified reference material
Aripiprazole solution, 1.0 mg/mL in acetonitrile, ampule of 1 mL, certified reference material
Aripiprazole-d8
Aripiprazole;
Aripiprazole/escitalopram fixed-dose combination
aripiprazolum
Aripiprex
Aripirazole
Arpizol
Asprito
BBL029082
BC208491
BCP9000317
BDBM50130293
Bio-0004
BMS-337039
BR-46736
Bristol-Myers Squibb brand of aripiprazole
C12564
C23H27Cl2N3O2
CA0141
CAS-129722-12-9
CCG-100891
CEUORZQYGODEFX-UHFFFAOYSA-N
CHEBI:31236
CHEMBL1112
CPD000466383
CS-0766
CTK0H5518
D01164
D0H3HM
D0P8CI
D0Y2GK
DB01238
DEHYDROARIPIPRAZOL
Discmelt
Discmelt (TN)
DL-178
DSSTox_CID_26083
DSSTox_GSID_46083
DSSTox_RID_81324
DTXSID3046083
EBD20357
FC0025
FT-0082572
FT-0600352
GTPL34
HE017185
HE328075
HMS2051I18
HMS2089M20
HMS2093F22
HMS2230M18
HMS3373D04
HMS3393I18
HMS3657K13
HSDB 7320
HY-14546
J-005707
J10066
KB-47438
KS-00000XK7
KS-1030
L001339
LP071262
LS-142666
MCULE-4329329262
MFCD00892072
MLS000759517
MLS001165779
MLS001195621
MLS001424078
MLS006011892
MolPort-002-885-808
NC00141
NCGC00159510-02
NCGC00159510-03
NCGC00159510-04
NCGC00159510-05
NSC-759266
NSC759266
Opc 14597
OPC 31
OPC-14597
OPC-31
Otsuka brand of aripiprazole
Pharmakon1600-01505851
Pripiprazole
PubChem18143
RTR-004086
S-4507
S06-0010
s1975
SAM001246750
SBI-0206870.P001
SC-16317
SCHEMBL12961254
SCHEMBL5335696
SCHEMBL8255
SMR000466383
ST2412627
STK625160
TL8000707
TL80090184
Tox21_111728
Tox21_111728_1
UNII-82VFR53I78
Z1541632800
ZINC1851149
Tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
➤ Sign Up➤ Sign Up10MGTABLET, ORALLY DISINTEGRATING; ORAL
➤ Sign Up➤ Sign Up30MGTABLET; ORALLY DISINTEGRATING
➤ Sign Up➤ Sign Up20MGTABLET, ORALLY DISINTEGRATING; ORAL

US Patents and Regulatory Information for aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-003 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-006 Nov 13, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ 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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Expired US Patents for aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-002 Jun 7, 2006 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for aripiprazole

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,999,952 Aripiprazole complex formulation and method ➤ Sign Up
9,439,582 Communication system with remote activation ➤ Sign Up
8,952,013 Controlled release sterile injectable aripiprazole formulation and method ➤ Sign Up
9,006,248 5-HT.sub.1A receptor subtype agonist ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for aripiprazole

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/GB04/039 United Kingdom ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE OR A SALT THEREOF; REGISTERED: UK EU/1/04/276/001 20040604; UK EU/1/04/276/002 20040604; UK EU/1/04/276/003 20040604; UK EU/1/04/276/004 20040604; UK EU/1/04/276/005 20040604; UK EU/1/04/276/006 20040604; UK EU/1/04/276/007 20040604; UK EU/1/04/276/008 20040604; UK EU/1/04/276/009 20040604; UK EU/1/04/276/010 20040604; UK EU/1/04/276/011 20040604; UK EU/1/04/276/012 20040604; UK EU/1/04/276/013 20040604; UK EU/1/04/276/014 20040604; UK EU/1/04/276/015 20040604; UK EU/1/04/276/016 20040604; UK EU/1/04/276/017 20040604; UK EU/1/04/276/018 20040604; UK EU/1/04/276/019 20040604; UK EU/1/04/276/020 20040604
2014020 Lithuania ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573/01 Switzerland ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
0669 Netherlands ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Johnson and Johnson
Argus Health
Merck
Daiichi Sankyo
US Army
QuintilesIMS
Dow
Moodys

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