Viewing data from:

ABILIFY ASIMTUFII

NDA

ARIPIPRAZOLE | N217006 | OTSUKA PHARMACEUTICAL CO LTD

2 strengths4 unique patents0 unique exclusivities

Patent Timeline

4 unique patents by expiration date

Active (4)Today

2027

2028

2029

2030

2031

2032

2033

Today

Apr. 23, 2033

Apr. 23, 2033

Apr. 23, 2033

Apr. 23, 2033

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

300 trials from ClinicalTrials.gov, 229 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Reducing Weight Gain and Improving Metabolic Function in Children Being Treated With Antipsychotics NCT00806234	Phase 4	Completed	Johns Hopkins University	127	2009-01 → 2014-03
A Preliminary Study of the Effectiveness and Tolerability of Aripiprazole in Bipolar Depression NCT00363337	Phase 4	Completed	Lindner Center of HOPE	31	2006-08 → 2009-03
A Study of Aripiprazole in Patients With Schizophrenia in General Psychiatric Practices NCT00292409	Phase 3	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	400	2005-03 → 2007-11
Optimizing Outcomes of Treatment-Resistant Depression in Older Adults NCT02960763	Phase 4	Completed	Washington University School of Medicine	742	2017-02-24 → 2021-09-01
Aripiprazole as an Adjunct to Atypical Antipsychotics for Weight Reduction and Improvement in Metabolic Profile NCT02949752	Phase 4	Completed	Institute of Mental Health, Singapore	67	2016-08 → 2020-01-01
Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of Alzheimer's Type NCT01438060	Phase 3	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	232	2000-08 → 2010-07
Effectiveness of Aripiprazole Long-acting Injection in Recent Onset and Chronic Schizophrenia Patients NCT03839251	Phase 4	Completed	Chonbuk National University Hospital	82	2018-06-01 → 2020-09-30
Study to Determine the Pharmacokinetics, Safety & Tolerability of Aripiprazole in Adults With Schizophrenia NCT03150771	Phase 1	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	36	2017-06-14 → 2018-05-02
A Study of Aripiprazole in the Management of Patients With Schizophrenia in the General Psychiatric Practices NCT00237939	Phase 3	Completed	Otsuka Pharmaceutical Development & Commercialization, Inc.	1,200	2002-09 → 2006-11
Effects of Aripiprazole on Cocaine Craving and Self-Administration NCT00373880	Phase 2	Completed	New York State Psychiatric Institute	26	2005-04 → 2008-09

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$1786.44

per ml

Lowest NADAC/Unit

$1773.64

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59148011480ABILIFY ASIMTUFII 960 MG/3.2 ML	$1786.44	ML	Brand	—	2026-06-17
59148010280ABILIFY ASIMTUFII 720 MG/2.4 ML	$1773.64	ML	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$3184.76

Highest Price

$5254.25

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59148-0102-80ABILIFY ASIMTUFII 720MG/2.4ML SYR INJ,SUSP,SA	$3940.69	FSS	Otsuka America Pharmaceutical, Inc.	03/14/2026
59148-0102-80ABILIFY ASIMTUFII 720MG/2.4ML SYR INJ,SUSP,SA	$3184.76	Big4	Otsuka America Pharmaceutical, Inc.	03/14/2026
59148-0114-80ABILIFY ASIMTUFII 960MG/3.2ML SYR INJ,SUSP,SA	$5254.25	FSS	Otsuka America Pharmaceutical, Inc.	03/14/2026
59148-0114-80ABILIFY ASIMTUFII 960MG/3.2ML SYR INJ,SUSP,SA	$4237.47	Big4	Otsuka America Pharmaceutical, Inc.	03/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Abilify Asimtufii (2024)

Total Spending

$63.1M

Total Claims

11,621

Beneficiaries

3,361

Avg Cost/Unit

$1764.24

Spending Trend

$13.2M(2023)→$63.1M(2024)

YoY Change:-1.1%

5yr CAGR:-1.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

Medicare Part B Spending

CMS physician-administered drug spending for Abilify Asimtufii (2024)

Total Spending

$89K

Total Claims

Beneficiaries

ASP Price

$5.89

HCPCS: J0402 — Injection, aripiprazole (abilify asimtufii), 1 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain49 active DMFs12 inactive

40 active API suppliers hold Drug Master Files for this ingredient.

ERREGIERRE SPAARIPIPRAZOLE USP-EP

DMF 187062005

CAMBREX CHARLES CITY INCARIPIPRAZOLE

DMF 187742005

MATRIX PHARMACORP PRIVATE LTDARIPIPRAZOLE USP

DMF 195542006

JUBILANT BIOSYS LTDARIPIPRAZOLE USP

DMF 197392006

ZYDUS LIFESCIENCES LTDARIPIPRAZOLE USP

DMF 198412006

OLON SPAARIPIPRAZOLE

DMF 199202006

TAPI NL BVARIPIPRAZOLE

DMF 199262006

APOTEX INCARIPIPRAZOLE USP

DMF 199572006

TAI HENG INDUSTRY CO LTDARIPIPRAZOLE

DMF 199822006

ORBION PHARMACEUTICALS PRIVATE LTDARIPIPRAZOLE (NON-STERILE BULK API)

DMF 219372008

HETERO LABS LTDARIPIPRAZOLE PROCESS II

DMF 225632009

SUVEN LIFE SCIENCES LTDARIPIPRAZOLE

DMF 228252009

NEULAND LABORATORIES LTDARIPIPRAZOLE USP (ANHYDROUS FORM - B)

DMF 228892009

ALEMBIC PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 233002009

ZAKLADY FARMACEUTYCZNE POLPHARMA SAARIPIPRAZOLE

DMF 233142009

MSN PHARMACHEM PRIVATE LTDARIPIPRAZOLE USP [ROUTE CODE - "AL1"]

DMF 240902010

UNICHEM LABORATORIES LTDARIPIPRAZOLE USP

DMF 240982010

ULKAR KIMYA SANAYII VE TICARET ASARIPIPRAZOLE

DMF 249372011

APITORIA PHARMA PRIVATE LTDARIPIPRAZOLE USP (NON-STERILE DRUG SUBSTANCE)

DMF 249972011

MACLEODS PHARMACEUTICALS LTDARIPIPRAZOLE

DMF 254722012

ZHEJIANG HUAHAI PHARMACEUTICAL CO LTDARIPIPRAZOLE USP

DMF 256852011

WOCKHARDT BIO AGARIPIPRAZOLE

DMF 267432013

ALKEM LABORATORIES LTDARIPIPRAZOLE USP

DMF 279092014

TOPHARMAN SHANDONG CO LTDARIPIPRAZOLE

DMF 285632014

MSN PHARMACHEM PRIVATE LTDARIPIPRAZOLE USP MONOHYDRATE [ROUTE CODE-HA]

DMF 291352015

CADILA PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 296802015

SMS PHARMACEUTICALS LTDARIPIPRAZOLE USP

DMF 299912015

COHANCE LIFESCIENCES LTDARIPIPRAZOLE USP

DMF 301202015

RUYUAN HEC PHARM CO LTDARIPIPRAZOLE NON-STERILE BULK DRUG SUBSTANCE

DMF 309542016

MATRIX PHARMACORP PRIVATE LTDARIPIPRAZOLE MONOHYDRATE

DMF 312572016

HETERO LABS LTDARIPIPRAZOLE PROCESS-I

DMF 314552017

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDARIPIPRAZOLE USP

DMF 324472018

ZAKLADY FARMACEUTYCZNE POLPHARMA SAARIPIPRAZOLE MONOHYDRATE

DMF 332042018

APITORIA PHARMA PRIVATE LTDARIPIPRAZOLE USP (PROCESS II)

DMF 338272019

INDOCO REMEDIES LTDARIPIPRAZOLE USP

DMF 339622019

INTERQUIM SAARIPIPRAZOLE MONOHYDRATE

DMF 349692021

GLAND PHARMA LTDARIPIPRAZOLE MONOHYDRATE – STERILE

DMF 362602021

NEULAND LABORATORIES LTDARIPIPRAZOLE MONOHYDRATE (STERILE)

DMF 364512021

GLAND PHARMA LTDARIPIPRAZOLE LAUROXIL – STERILE

DMF 365222021

REYOUNG CORPORATIONARIPIPRAZOLE

DMF 367232022

SUN PHARMACEUTICAL INDUSTRIES LTDARIPIPRAZOLE USP

DMF 367742022

INTERQUIM SAARIPIPRAZOLE MONOHYDRATE STERILE

DMF 371842022

QILU PHARMACEUTICAL CO LTDARIPIPRAZOLE MONOHYDRATE (STERILE)

DMF 402142024

QILU PHARMACEUTICAL CO LTD (LAOLING SITE)ARIPIPRAZOLE

DMF 403362024

CHROMO LABORATORIES INDIA PRIVATE LTDARIPIPRAZOLE USP

DMF 407382025

SURAJ LABORATORIES PRIVATE LTDARIPIPRAZOLE USP

DMF 414582025

ALEMBIC PHARMACEUTICALS LTDARIPIPRAZOLE MONOHYDRATE

DMF 436242026

VASUDHA PHARMA CHEM LTDARIPIPRAZOLE USP

DMF 437742026

YANGTZE RIVER PHARMACEUTICAL GROUP JIANGSU HAICI BIOLOGICAL PHARMACEUTICAL CO LTDARIPIPRAZOLE NON-STERILE DRUG SUBSTANCE

DMF 438022026

BRISTOL MYERS SQUIBB COInactiveARIPIPRAZOLE TABLETS

DMF 156512001

DR REDDYS LABORATORIES LTDInactiveARIPIPRAZOLE

DMF 184712005

IND SWIFT LABORATORIES LTDInactiveARIPIPRAZOLE

DMF 192032006

SYNTHON BVInactiveARIPIPRAZOLE

DMF 196822006

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveARIPIPRAZOLE

DMF 199492006

CIPLA LTDInactiveARIPIPRAZOLE

DMF 201892007

CADILA PHARMACEUTICALS LTDInactiveARIPIPRAZOLE

DMF 204642007

SMS PHARMACEUTICALS LTDInactiveARIPIPRAZOLE

DMF 223392008

ZHEJIANG JINHUA CONBA BIO-PHARM CO LTDInactiveARIPIPRAZOLE

DMF 259962012

MAPRIMED SAInactiveARIPIPRAZOLE

DMF 269212013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveARIPIPRAZOLE USP

DMF 283412014

AMOLI ORGANICS PVT LTDInactiveARIPIPRAZOLE USP

DMF 291382015

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Apr 9, 2025	SUPPL -1	View Letter (PDF)
Feb 7, 2025	SUPPL -2	View Letter (PDF)
Apr 28, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 720MG/2.4ML (300MG/ML)

RLD

4 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Apr 27, 2023

Patents (4) · 8 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
10517951	Apr 23, 2033	—	—	Yes	—
11097007	Apr 23, 2033	—	—	Yes	—
11638757	Apr 23, 2033	—	—	Yes	—
12016927	Apr 23, 2033	—	—	Yes	—

#002 — 960MG/3.2ML (300MG/ML)

RLD

4 patents0 exclusivities▾

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Apr 27, 2023