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Last Updated: February 20, 2020

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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 patent protection?

Aripiprazole is the generic ingredient in six branded drugs marketed by Otsuka Pharm Co Ltd, Otsuka, Amneal Pharms, Apotex Inc, Aurobindo Pharma Ltd, Lannett Co Inc, Vistapharm, Alembic Pharms Ltd, Orchid Hlthcare, Sciegen Pharms Inc, Zydus Pharms, Accord Hlthcare, Ajanta Pharma Ltd, Alkem Labs Ltd, Boscogen, Hetero Labs Ltd V, Macleods Pharms Ltd, Mylan, Prinston Inc, Teva Pharms Usa, Torrent, and Alkermes Inc, and is included in thirty-six NDAs. There are fifty-eight 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 eighty-six patent family members in fifty-seven countries.

There are forty-nine drug master file entries for aripiprazole. Forty-two suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for aripiprazole

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Drug Sales Revenue Trends for aripiprazole

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Recent Clinical Trials for aripiprazole

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

SponsorPhase
University of Colorado, DenverPhase 2
University of California, Los AngelesPhase 4
PRA Health SciencesPhase 1

See all aripiprazole clinical trials

Recent Litigation for aripiprazole

Identify potential future generic entrants

District Court Litigation
Case NameDate
OTSUKA PHARMACEUTICAL CO. LTD. v. ORCHID PHARMA LTD.2016-12-30
OTSUKA PHARMACEUTICAL CO., LTD. v. ALKEM LABORATORIES LIMITED2016-09-26
Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA2016-05-03

See all aripiprazole litigation

PTAB Litigation
PetitionerDate
2016-11-17

See all aripiprazole litigation

Generic filers with tentative approvals for ARIPIPRAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial10MGTABLET, ORALLY DISINTEGRATING; ORAL
  Start Trial  Start Trial30MGTABLET; ORALLY DISINTEGRATING
  Start Trial  Start Trial20MGTABLET, ORALLY DISINTEGRATING; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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-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)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-bis(chloranyl)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)-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
9SC
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
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 D8
Aripiprazole Depot
Aripiprazole solution, 1.0 mg/mL (50:50 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;
aripiprazolum
Aripiprex
Aripirazole
Aristada (aripiprazole lauroxil)
BBL029082
BC208491
BCP04902
BCP9000317
BDBM50130293
BMS-337039
BR-46736
BRD-K70358946-001-06-6
C12564
C23H27Cl2N3O2
CA0141
CAS-129722-12-9
CCG-100891
CEUORZQYGODEFX-UHFFFAOYSA-N
CHEBI:31236
CHEMBL1112
CPD000466383
CS-0766
CTK0H5518
D01164
DB01238
Discmelt
DL-178
DSSTox_CID_26083
DSSTox_GSID_46083
DSSTox_RID_81324
DTXSID3046083
EBD20357
FC0025
FT-0082572
FT-0600352
GTPL34
HMS2051I18
HMS2089M20
HMS2093F22
HMS2230M18
HMS3373D04
HMS3393I18
HMS3657K13
HMS3715J07
HSDB 7320
HY-14546
J-005707
J10066
KB-47438
KS-00000XK7
KS-1030
L001339
LS-142666
MCULE-4329329262
MFCD00892072 (97%)
MLS000759517
MLS001165779
MLS001195621
MLS001424078
MLS006011892
MolPort-002-885-808
NC00141
NCGC00159510-02
NCGC00159510-03
NCGC00159510-04
NCGC00159510-05
NSC-759266
NSC759266
Opc 14597
OPC 14597; OPC 31
OPC 31
OPC-14597
OPC-31
Pharmakon1600-01505851
PubChem18143
RTR-004086
S-4507
S06-0010
s1975
SAM001246750
SBI-0206870.P001
SC-16317
SCHEMBL12961254
SCHEMBL5335696
SCHEMBL8255
SMR000466383
SR-01000759353
SR-01000759353-4
SR-01000759353-6
ST2412627
STK625160
SW197521-3
SY053146
TL8000707
TL80090184
Tox21_111728
Tox21_111728_1
UNII-82VFR53I78
Z1541632800
ZINC1851149
Paragraph IV (Patent) Challenges for ARIPIPRAZOLE
Tradename Dosage Ingredient NDA Submissiondate
ABILIFY SOLUTION;ORAL aripiprazole 021713 2007-12-20
ABILIFY TABLET;ORAL aripiprazole 021436 2006-11-15
ABILIFY TABLET, ORALLY DISINTEGRATING;ORAL aripiprazole 021729 2006-11-15

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 ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-005 Jun 7, 2006 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-003 Sep 29, 2014 RX Yes No   Start Trial   Start Trial Y   Start Trial
Torrent ARIPIPRAZOLE aripiprazole TABLET;ORAL 201519-001 Apr 28, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-001 Nov 13, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-002 Nov 13, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-005 Nov 13, 2017 RX Yes No   Start Trial   Start Trial Y   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 aripiprazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002   Start Trial   Start Trial
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for aripiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 C01675573/01 Switzerland   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: SWISSMEDIC 63177 28.04.2014
0367141 SPC/GB04/039 United Kingdom   Start Trial 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
1675573 C300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 239 5013-2014 Slovakia   Start Trial PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
1675573 PA2014020 Lithuania   Start Trial PRODUCT NAME: ARIPIPRAZOLUM; REGISTRATION NO/DATE: EU/1/13/882 20131115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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