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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.

Summary for aripiprazole

International Patents:	886
US Patents:	58
Tradenames:	6
Applicants:	22
NDAs:	36
Drug Master File Entries:	49
Suppliers / Packagers:	42
Bulk Api Vendors:	126
Clinical Trials:	344
Patent Applications:	6,245
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for aripiprazole
Drug Sales Revenues:	Drug sales revenues for aripiprazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for aripiprazole
DailyMed Link:	aripiprazole at DailyMed

See drug prices for aripiprazole

See drug sales revenues for aripiprazole

Recent Clinical Trials for aripiprazole

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

Sponsor	Phase
University of Colorado, Denver	Phase 2
University of California, Los Angeles	Phase 4
PRA Health Sciences	Phase 1

See all aripiprazole clinical trials

Recent Litigation for aripiprazole

Identify potential future generic entrants

District Court Litigation

Case Name	Date
OTSUKA PHARMACEUTICAL CO. LTD. v. ORCHID PHARMA LTD.	2016-12-30
OTSUKA PHARMACEUTICAL CO., LTD. v. ALKEM LABORATORIES LIMITED	2016-09-26
Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA	2016-05-03

See all aripiprazole litigation

PTAB Litigation

Petitioner	Date
	2016-11-17

See all aripiprazole litigation

Generic filers with tentative approvals for ARIPIPRAZOLE

Applicant	Application No.	Strength	Dosage Form
		10MG	TABLET, ORALLY DISINTEGRATING; ORAL
		30MG	TABLET; ORALLY DISINTEGRATING
		20MG	TABLET, 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

Drug Class

Atypical Antipsychotic

Medical Subject Heading (MeSH) Categories for aripiprazole

Antipsychotic Agents

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

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
Otsuka	ABILIFY	aripiprazole	TABLET, ORALLY DISINTEGRATING;ORAL	021729-003	Jun 7, 2006
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-001	Nov 15, 2002
Otsuka	ABILIFY	aripiprazole	SOLUTION;ORAL	021713-001	Dec 10, 2004
Otsuka	ABILIFY	aripiprazole	TABLET;ORAL	021436-006	Nov 15, 2002
Otsuka Pharm Co Ltd	ABILIFY MAINTENA KIT	aripiprazole	FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR	202971-001	Feb 28, 2013

International Patents for aripiprazole

Country	Patent Number	Estimated Expiration
Morocco	33727
Norway	20050661
Brazil	0208986
Taiwan	I315669
European Patent Office	2734973
Taiwan	200524638

Supplementary Protection Certificates for aripiprazole

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