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ABILIFY MAINTENA KIT Drug Profile

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Which patents cover Abilify Maintena Kit, 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 nine 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-three 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 January 24^th, 2020.

Summary for ABILIFY MAINTENA KIT

International Patents:	243
US Patents:	9
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	126
Clinical Trials:	8
Patent Applications:	4,071
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

See drug prices for ABILIFY MAINTENA KIT

Recent Clinical Trials for ABILIFY MAINTENA KIT

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

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

See all ABILIFY MAINTENA KIT clinical trials

Recent Litigation for ABILIFY MAINTENA KIT

Identify potential future generic entrants

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

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-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 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

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

US Patents and Regulatory Information for ABILIFY MAINTENA KIT

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				Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No			Y
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014		RX	Yes	No			Y

Expired US Patents for ABILIFY MAINTENA KIT

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	202971-001	Feb 28, 2013
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-004	Sep 29, 2014
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-002	Feb 28, 2013

International Patents for ABILIFY MAINTENA KIT

Country	Patent Number	Estimated Expiration
Georgia, Republic of	P20115205
China	103755632
Canada	2689052

Supplementary Protection Certificates for ABILIFY MAINTENA KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1675573	2014C/029	Belgium		PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
1675573	92427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
1675573	122014000057	Germany		PRODUCT NAME: ARIPIPRAZOL; REGISTRATION NO/DATE: EU/1/13/882 20131115