ARIPIPRAZOLE | N021713 | OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
OTSUKA PHARMACEUTICAL CO., LTD. v. SILARX PHARMACEUTICALS, INC. 1 patentANDA 204171aripiprazole | D.N.J. | 2012-09-14 | Terminated 2014-05-05 | — |
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 |
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.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8759350 | Mar 2, 2027 | — | — | — | — |