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Generated: May 22, 2019

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

There are forty-nine drug master file entries for aripiprazole. Forty-nine 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-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
Generic filers with 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

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

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;ORAL 021436-003 Nov 15, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-003 Nov 15, 2002 AB RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 AB RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Orchid Hlthcare ARIPIPRAZOLE aripiprazole TABLET;ORAL 202683-003 May 23, 2017 AB RX No No ➤ Sign Up ➤ Sign Up ➤ 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 Y ➤ Sign Up
Otsuka ABILIFY aripiprazole SOLUTION;ORAL 021713-001 Dec 10, 2004 DISCN Yes No ➤ Sign Up ➤ Sign Up ➤ 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 INJECTABLE;INTRAMUSCULAR 021866-001 Sep 20, 2006 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET, ORALLY DISINTEGRATING;ORAL 021729-003 Jun 7, 2006 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-001 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Otsuka Pharm Co Ltd ABILIFY MAINTENA KIT aripiprazole FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR 202971-001 Feb 28, 2013 ➤ Sign Up ➤ Sign Up
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for aripiprazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 239 5013-2014 Slovakia ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882/001 - EU/1/13/882/004 20131119
0367141 SPC/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
1675573 122014000057 Germany ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 32/2014 Austria ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
1675573 CA 2014 00026 Denmark ➤ Sign Up PRODUCT NAME: ARIPIPRAZOL; REG. NO/DATE: EU/1/13/882/001-004 20131115
1675573 92427 Luxembourg ➤ Sign Up PRODUCT NAME: ARIPIPRAZOLE
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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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.