Petition	Type	Filed	Status	Petitioner
Citizen Petition from Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceuti... FDA-2014-P-1354 · 4 docket documents Otsuka Pharmaceutical Development & Commercialization, Inc. filed this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA refuse to accept for substantive review an NDA submitted by Alkermes plc for aripiprazole lauroxil, arguing that the applicatio	505(q)	2014-09-11	Denied	Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceutical Development & Commercialization, Inc.)

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

5 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Study of Aripiprazole Lauroxil in Subjects With Schizophrenia or Schizoaffective Disorder NCT02636842	Phase 1	Completed	Alkermes, Inc.	47	2015-12 → 2016-06
A Study of Aripiprazole Lauroxil or Paliperidone Palmitate for the Treatment of Schizophrenia NCT03345979	Phase 3	Completed	Alkermes, Inc.	200	2017-11-15 → 2019-03-12
An Open-Label Study of Aripiprazole Lauroxil in Subjects With Stable Schizophrenia NCT02320032	Phase 1	Completed	Alkermes, Inc.	140	2014-12 → 2016-04
A Study of Aripiprazole Lauroxil (Also Known as ARISTADA TM) in Subjects With Schizophrenia NCT02634320	Phase 4	Completed	Alkermes, Inc.	51	2015-12 → 2017-07-11
Aripiprazole Lauroxil for Preventing Psychotic Relapse After an Initial Schizophrenia Episode NCT04203056	Phase 4	Terminated	University of California, Los Angeles	15	2019-12-16 → 2022-10-01

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$1005.89

per ml

Lowest NADAC/Unit

$988.98

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
65757040203ARISTADA ER 662 MG/2.4 ML SYRN	$1005.89	ML	Brand	—	2026-06-17
65757040303ARISTADA ER 882 MG/3.2 ML SYRN	$1001.01	ML	Brand	—	2026-06-17
65757040103ARISTADA ER 441 MG/1.6 ML SYRN	$991.81	ML	Brand	—	2026-06-17
65757040403ARISTADA ER 1,064 MG/3.9 ML SYR	$988.98	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 | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$1089.78

Highest Price

$3619.96

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
65757-0403-03ARISTADA 882MG/3.2ML INJ KIT	$3000.76	FSS	Alkermes, Inc.	07/31/2026
65757-0403-03ARISTADA 882MG/3.2ML INJ KIT	$2195.84	Big4	Alkermes, Inc.	07/31/2026
65757-0401-03ARISTADA 441MG/1.6ML INJ KIT	$1500.39	FSS	Alkermes, Inc.	07/31/2026
65757-0401-03ARISTADA 441MG/1.6ML INJ KIT	$1089.78	Big4	Alkermes, Inc.	07/31/2026
65757-0402-03ARISTADA 662MG/2.4ML INJ KIT	$2252.26	FSS	Alkermes, Inc.	07/31/2026
65757-0402-03ARISTADA 662MG/2.4ML INJ KIT	$1638.42	Big4	Alkermes, Inc.	07/31/2026
65757-0404-03ARISTADA 1064MG/3.9ML INJ KIT	$3619.96	FSS	Alkermes, Inc.	07/31/2026
65757-0404-03ARISTADA 1064MG/3.9ML INJ KIT	$2656.76	Big4	Alkermes, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Aristada (2024)

Total Spending

$269.1M

Total Claims

90,057

Beneficiaries

13,102

Avg Cost/Unit

$976.79

Spending Trend

$160.4M(2019)→$203.1M(2020)→$230.4M(2021)→$256.9M(2022)→$272.9M(2023)→$269.1M(2024)

YoY Change:-0.4%

5yr CAGR:+2.9%

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 Aristada (2024)

Total Spending

$1.5M

Total Claims

992

Beneficiaries

211

ASP Price

$3.17

Spending Trend

$177K(2019)→$845K(2020)→$1.1M(2021)→$1.4M(2022)→$1.4M(2023)→$1.5M(2024)

YoY Change:+1.7%

5yr CAGR:+4.8%

HCPCS: J1944 — Injection, aripiprazole lauroxil, (aristada), 1 mg

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

API Supply Chain4 active DMFs

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

ZAKLADY FARMACEUTYCZNE POLPHARMA SAARIPIPRAZOLE LAUROXIL

DMF 315312018

MSN PHARMACHEM PRIVATE LTDARIPIPRAZOLE LAUROXIL

DMF 321472017

NEULAND LABORATORIES LTDARIPIPRAZOLE LAUROXIL

DMF 326832018

INTERQUIM SAARIPIPRAZOLE LAUROXIL

DMF 399542024

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

Approval Letters

8 letters from Drugs@FDA

Date	Submission	Document
Feb 7, 2025	SUPPL -31	View Letter (PDF)
Mar 31, 2021	SUPPL -21	View Letter (PDF)
Aug 28, 2020	SUPPL -17	View Letter (PDF)
Jan 30, 2018	SUPPL -9	View Letter (PDF)
Jun 7, 2017	SUPPL -4	View Letter (PDF)
Mar 2, 2017	SUPPL -6	View Letter (PDF)
Aug 18, 2016	SUPPL -3	View Letter (PDF)
Oct 13, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 441MG/1.6ML (275.63MG/ML)

RLD

17 patents0 exclusivities▴

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Oct 5, 2015

Patents (17) · 15 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8431576	Oct 26, 2030	—	Yes	—	—	—
8796276	Jun 24, 2030	—	—	—		—
9034867	Nov 7, 2032	—	—	Yes		—
9193685	Oct 24, 2033	—	—	Yes		—
9452131	Mar 19, 2035	—	—	—		—
10112903	Jun 24, 2030	—	Yes	—		—
10226458	Mar 19, 2032	—	—	—		—
10238651	Mar 19, 2035	—	—	—		—
10813928	Mar 19, 2035	—	—	—		—
11097006	Oct 24, 2033	—	—	Yes		—
11273158	Apr 6, 2039	—	—	—		—
11406632	Mar 19, 2035	—	—	—		—
11969469	Oct 24, 2033	—	—	Yes	—	—
12251381	Apr 6, 2039	—	—	—		—
12311027	Sep 19, 2033	—	—	Yes		—
12629366Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Dec 6, 2032	—	—	Yes		—
12653822Newly listed — daily FDA feed, not yet in monthly Orange Book edition	Mar 19, 2035	—	—	—		—

#002 — 662MG/2.4ML (275.83MG/ML)

RLD

18 patents0 exclusivities▾

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Oct 5, 2015

#003 — 882MG/3.2ML (275.63MG/ML)

RLD

18 patents0 exclusivities▾

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Oct 5, 2015

#004 — 1064MG/3.9ML (272.82MG/ML)

RLD

17 patents0 exclusivities▾

SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR | Approved: Jun 5, 2017