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Last Updated: October 20, 2019

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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 fifty patents protecting this drug and three Paragraph IV challenges.

This drug has four hundred and twenty-eight patent family members in fifty-one countries.

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

Drug patent expirations by year for ABILIFY
Drug Prices for ABILIFY

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Drug Sales Revenue Trends for ABILIFY

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Recent Clinical Trials for ABILIFY

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

SponsorPhase
New York State Institute for Basic ResearchPhase 2
Rutgers, The State University of New JerseyPhase 2
New Jersey Governor’s Council for Medical Research and Treatment of AutismPhase 2

See all ABILIFY clinical trials

Recent Litigation for ABILIFY

Identify potential future generic entrants

District Court Litigation
Case NameDate
OTSUKA PHARMACEUTICAL CO. LTD. v. ORCHID PHARMA LTD.2016-12-30
OTSUKA PHARMACEUTICAL CO., LTD. v. ALKEM LABORATORIES LIMITED2016-09-26
Otsuka Pharmaceutical Co. v. Zydus Pharmaceuticals USA2016-05-03

See all ABILIFY litigation

PTAB Litigation
PetitionerDate
Alkermes Pharma Ireland Limited2016-11-17

See all ABILIFY litigation

Pharmacology for ABILIFY
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-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 (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
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

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   Start Trial   Start Trial Y   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002 AB RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Otsuka Pharm Co Ltd ABILIFY MYCITE KIT aripiprazole TABLET;ORAL 207202-004 Nov 13, 2017 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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-005 Nov 15, 2002   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-006 Nov 15, 2002   Start Trial   Start Trial
Otsuka ABILIFY aripiprazole TABLET;ORAL 021436-004 Nov 15, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for ABILIFY
Drugname Dosage Strength RLD Date
➤ Subscribe Oral Solution 1 mg/mL ➤ Subscribe   Start Trial
➤ Subscribe Orally Disintegrating Tablets 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for ABILIFY

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1675573 C300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 300669 Netherlands   Start Trial PRODUCT NAME: ARIPIPRAZOLE; REGISTRATION NO/DATE: EU/1/13/882 20131115
1675573 2014C/029 Belgium   Start Trial PRODUCT NAME: ARIPIPRAZOLE; AUTHORISATION NUMBER AND DATE: EU/1/13/882 20131119
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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McKinsey
Boehringer Ingelheim
AstraZeneca
Express Scripts
Johnson and Johnson
Mallinckrodt

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