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 | — |
Otsuka Pharmaceutical Co., Ltd. et al v. Mylan Laboratories Limited et al 10 patentsANDA 216608aripiprazole | WVND | 2022-11-10 | Terminated 2023-03-07 | — |
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 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 |
Citizen Petition from Otsuka Pharmaceutical Development and Commercialization... FDA-2015-P-2482 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 |
Citizen Petition from Otsuka Pharmaceutical Company Ltd., (Otsuka Pharmaceuti... FDA-2014-P-1354 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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.