ARIPIPRAZOLE | N202971 | OTSUKA PHARMACEUTICAL CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Otsuka Pharmaceutical Co., Ltd. et al v. Alvogen, Inc. et al 6 patentsANDA 216913aripiprazole | D. Del. | 2025-02-14 | Active | — |
Otsuka Pharmaceutical Co., Ltd. et al v. Apotex Inc. et al 6 patentsANDA 219381aripiprazole | D. Del. | 2024-08-30 | Active | — |
| D. Del. | 2024-07-05 | Terminated 2025-10-21 | — | |
Otsuka Pharmaceutical Co., Ltd. et al v. Mylan Laboratories Limited et al 10 patentsANDA 216608aripiprazole | N.D. W. Va. | 2022-11-10 | Terminated 2023-03-07 | — |
| D. Del. | 2022-10-17 | Terminated 2024-05-30 | — | |
| D. Del. | 2022-08-26 | Terminated 2024-05-30 | — | |
Otsuka Pharmaceutical Co., Ltd. et al v. Mylan Laboratories Limited et al 8 patentsANDA 216608aripiprazole | D. Del. | 2022-04-08 | Terminated 2024-05-30 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from E. Rust Consulting, LLC FDA-2025-P-0877 · 8 docket documents Ellen Rust of E. Rust Consulting, LLC filed this petition requesting FDA permission to submit an ANDA under section 505(j) for Aripiprazole Extended-Release Injectable Suspension, 200 mg/mL in ready-to-use pre-filled syringes and vials (300 mg and 400 mg strengths), referencing the RLD ABILIFY MAINT | Suitability | 2025-03-25 | Open | E. Rust Consulting, LLC |
Citizen Petition from Otsuka Pharmaceutical Development and Commercialization... FDA-2015-P-2482 · 12 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 approve or delay approval of Alkermes plc's NDA for aripiprazole lauroxil on two grounds: that approval should be wit | 505(q) | 2015-07-14 | Denied | Otsuka Pharmaceutical Development and Commercialization, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$2860.98
per ea
Lowest NADAC/Unit
$2137.32
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59148001971ABILIFY MAINTENA ER 400 MG VL | $2860.98 | EA | Brand | — | 2026-06-17 |
| 59148024512ABILIFY MAINTENA ER 400 MG VL | $2860.98 | EA | Brand | — | 2026-06-17 |
| 59148007280ABILIFY MAINTENA ER 400 MG SYR | $2854.93 | EA | Brand | — | 2026-06-17 |
| 59148001871ABILIFY MAINTENA ER 300 MG VL | $2142.38 | EA | Brand | — | 2026-06-17 |
| 59148023212ABILIFY MAINTENA ER 300 MG VL | $2142.38 | EA | Brand | — | 2026-06-17 |
| 59148004580ABILIFY MAINTENA ER 300 MG SYR | $2137.32 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.