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ABILIFY Drug Profile

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Which patents cover Abilify, and when can generic versions of Abilify launch?

Abilify is a drug marketed by Otsuka and Otsuka Pharm Co Ltd and is included in six NDAs. There are forty-eight patents protecting this drug and three Paragraph IV challenges.

This drug has four hundred and twenty-four patent family members in forty-nine countries.

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

Summary for ABILIFY

International Patents:	424
US Patents:	15
Applicants:	2
NDAs:	6
Suppliers / Packagers:	10
Bulk Api Vendors:	112
Clinical Trials:	59
Patent Applications:	3,527
Formulation / Manufacturing:	see details
Drug Prices:	see details
DailyMed Link:	ABILIFY at DailyMed

Pharmacology for ABILIFY

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for ABILIFY

Antipsychotic Agents

Synonyms for ABILIFY

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 (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

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

US Patents and Regulatory Information for ABILIFY

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	207202-006	Nov 13, 2017		RX	Yes	No			Y
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-005	Nov 15, 2002	AB	RX	Yes	Yes
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-004	Nov 13, 2017		RX	Yes	No			Y
Otsuka Pharm Co Ltd	ABILIFY MYCITE KIT	aripiprazole	TABLET;ORAL	207202-002	Nov 13, 2017		RX	Yes	Yes			Y

Expired US Patents for ABILIFY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-004	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-002	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	INJECTABLE;INTRAMUSCULAR	021866-001	Sep 20, 2006

Paragraph IV (Patent) Challenges for ABILIFY

Drugname	Dosage	Strength	RLD	Submissiondate
	Oral Solution	1 mg/mL		2007-12-20
	Orally Disintegrating Tablets	10 mg, 15 mg, 20 mg and 30 mg		2006-11-15
	Tablets	2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg		2006-11-15

Non-Orange Book US Patents for ABILIFY

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
8,604,041	Method of treating panic disorder
8,623,874	Method of treating neurodegenerative diseases
8,680,105	Method of treating down's syndrome
8,030,312	5-HT1A receptor subtype agonist

International Patents for ABILIFY

Country	Document Number	Estimated Expiration
Ukraine	85235
Norway	20041383
South Korea	20030096332
Hungary	0500638

Supplementary Protection Certificates for ABILIFY

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
427	Luxembourg		PRODUCT NAME: ARIPIPRAZOLE
0669	Netherlands		PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
C/GB04/039	United Kingdom		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