ARIPIPRAZOLE | N021436 | OTSUKA PHARMACEUTICAL CO LTD
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2017-00287 | 9125939 | IPR | Alkermes Pharma Ireland Limited et al. | Institution Denied | 2016-11-17 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2014-12-24 | Terminated 2017-09-29 | — | |
| D.N.J. | 2014-07-11 | Terminated 2018-03-05 | — | |
OTSUKA PHARMACEUTICAL CO., LTD. v. SUN PHARMACEUTICAL INDUSTRIES LTD. et al 3 patentsANDA 78614aripiprazole | D.N.J. | 2014-07-07 | Terminated 2016-03-10 | — |
OTSUKA PHARMACEUTICAL CO., LTD. v. WOCKHARDT BIO AG et al 2 patentsANDA 20607aripiprazole | D.N.J. | 2014-03-28 | Terminated 2014-11-03 | — |
OTSUKA PHARMACEUTICAL CO., LTD. v. ZYDUS PHARMACEUTICALS USA, INC. et al 1 patentANDA 090472aripiprazole | D.N.J. | 2010-06-04 | Terminated 2010-11-15 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from E. Rust Consulting, LLC FDA-2025-P-0877 · 8 docket documents E. Rust Consulting, LLC filed this amendment to an ANDA suitability petition for aripiprazole extended-release injectable suspension in prefilled syringes and single-dose vials at 300 mg and 400 mg strengths, requesting a full waiver from pediatric study requirements under the Pediatric Research Equ | Suitability | 2025-04-17 | Open | E. Rust Consulting, LLC |
Citizen Petition from David Behar FDA-2025-P-0986 · 3 docket documents David Behar, M.D., a board-certified psychiatrist, filed this citizen petition requesting that the FDA place aripiprazole 5 mg over-the-counter for treatment of irritability and disruptive mood dysregulation disorder, currently approved only by prescription. The petition also requests that manufactu | Other | 2025-03-28 | Open | David Behar |
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. |
Rakoczy Molino Mazzochi Siwik LLP - Citizen Petition FDA-2008-P-0330 · 5 docket documents Law firm Rakoczy Molino Mazzochi Siwik LLP filed this citizen petition requesting that FDA determine whether Otsuka Pharmaceutical discontinued ABILIFY DISCMELT (Aripiprazole) Orally Disintegrating Tablets in 20 mg and 30 mg strengths, approved under NDA 21-729, for reasons unrelated to safety and e | 505(q) | 2008-06-11 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$26.29
per ea
Lowest NADAC/Unit
$18.60
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59148001013ABILIFY 20 MG TABLET | $26.29 | EA | Brand | $0.1711 | 2026-06-17 |
| 59148001113ABILIFY 30 MG TABLET | $26.21 | EA | Brand | $0.1670 | 2026-06-17 |
| 59148000713ABILIFY 5 MG TABLET | $18.66 | EA | Brand | $0.1074 | 2026-06-17 |
| 59148000613ABILIFY 2 MG TABLET | $18.65 | EA | Brand | $0.1045 | 2026-06-17 |
| 59148000913ABILIFY 15 MG TABLET | $18.62 | EA | Brand | $0.1289 | 2026-06-17 |
| 59148000813ABILIFY 10 MG TABLET | $18.60 | EA | Brand | $0.0980 | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.