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ABILIFY MAINTENA KIT Drug Profile

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When do Abilify Maintena Kit patents expire, and when can generic versions of Abilify Maintena Kit launch?

Abilify Maintena Kit is a drug marketed by Otsuka Pharm Co Ltd and is included in one NDA. There are ten patents protecting this drug.

This drug has two hundred and forty-three patent family members in thirty-eight countries.

The generic ingredient in ABILIFY MAINTENA KIT is aripiprazole. There are forty-nine drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the aripiprazole profile page.

US ANDA Litigation and Generic Entry Outlook for Abilify Maintena Kit

A generic version of ABILIFY MAINTENA KIT was approved as aripiprazole by ALEMBIC PHARMS LTD on April 28^th, 2015.

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Summary for ABILIFY MAINTENA KIT

International Patents:	243
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	129
Clinical Trials:	8
Patent Applications:	4,048
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ABILIFY MAINTENA KIT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ABILIFY MAINTENA KIT
DailyMed Link:	ABILIFY MAINTENA KIT at DailyMed

Drug patent expirations by year for ABILIFY MAINTENA KIT

Recent Clinical Trials for ABILIFY MAINTENA KIT

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Sponsor	Phase
Otsuka Beijing Research Institute	Phase 1
Otsuka Pharmaceutical Co., Ltd.	Phase 4
Chonbuk National University Hospital	Phase 4

See all ABILIFY MAINTENA KIT clinical trials

Recent Litigation for ABILIFY MAINTENA KIT

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District Court Litigation

Case Name	Date
OTSUKA PHARMACEUTICAL CO., LTD. v. STASON INDUSTRIAL CORP.	2016-02-01
OTSUKA PHARMACEUTICAL CO. LTD. v. TEVA PHARMACEUTICALS USA, INC.	2014-10-10
OTSUKA PHARMACEUTICAL CO., LTD. v. ZYDUS PHARMACEUTICALS USA INC.	2014-05-16

See all ABILIFY MAINTENA KIT litigation

PTAB Litigation

Petitioner	Date
	2017-06-09

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Synonyms for ABILIFY MAINTENA KIT

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-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)-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
A11801
A19454
AB0008434
AB00639935_10
AB00639935_11
AB00639935-09
AB07660
AB1006698
Abilify
Abilify (TN)
Abilify Digital
Abilify Discmelt
Abilify Maintena
Abilify MyCite
Abilify OD
Abilitat
AC-1554
ACMC-20emtv
ACT03221
AK-46736
AKOS005558247
AM20090766
AOB5922
aripiprazol
Aripiprazole
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-abilify
aripiprazole; 7-(4-(4-(2,3-dichlorophenyl)-1-piperazinyl)butoxy)-3,4-dihydrocarbostyril
aripiprazolum
Aripiprex
Aripirazole
Aristada (aripiprazole lauroxil)
BBL029082
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
FT-0082572
FT-0600352
GTPL34
HMS2051I18
HMS2089M20
HMS2093F22
HMS2230M18
HMS3373D04
HMS3393I18
HMS3657K13
HMS3715J07
HMS3744A13
HSDB 7320
HY-14546
J-005707
J10066
KS-00000XK7
KS-1030
L001339
LS-142666
MCULE-4329329262
MFCD00892072
MLS000759517
MLS001165779
MLS001195621
MLS001424078
MLS006011892
NC00141
NCGC00159510-02
NCGC00159510-03
NCGC00159510-04
NCGC00159510-05
NSC-759266
NSC759266
Opc 14597
OPC 31
OPC-14597
OPC-31
Pharmakon1600-01505851
PubChem18143
Q411188
RTR-004086
S-4507
s1975
SAM001246750
SBI-0206870.P001
SC-16317
SCHEMBL12961254
SCHEMBL5335696
SCHEMBL8255
SMR000466383
SR-01000759353
SR-01000759353-4
SR-01000759353-6
ST2412627
STK625160
SW197521-3
SY053146
Tox21_111728
Tox21_111728_1
UNII-82VFR53I78
Z1541632800
ZINC1851149

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

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Glossary

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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 MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	Start Trial	Start Trial				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
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	Start Trial	Start Trial	Y			Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013		RX	Yes	Yes	Start Trial	Start Trial		Y		Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	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
>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 ABILIFY MAINTENA KIT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014	Start Trial	Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013	Start Trial	Start Trial
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-003	Sep 29, 2014	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

International Patents for ABILIFY MAINTENA KIT

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Country	Patent Number	Estimated Expiration
Chile	2010000405	Start Trial
Israel	153838	Start Trial
China	1845721	Start Trial
Russian Federation	2279429	Start Trial
Australia	2004285448	Start Trial
Hong Kong	1210468	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	32/2014	Austria	Start Trial	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 (MITTEILUNG) 20131119
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
1675573	122014000057	Germany	Start Trial	PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115
0367141	C300161	Netherlands	Start Trial	PRODUCT NAME: ARIPIPRAZOLUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/04/276/001-005;006-010;011-015;016-020 20040604
0367141	C00367141/01	Switzerland	Start Trial	FORMER REPRESENTATIVE: BOHEST AG, CH
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description