CARIPRAZINE HYDROCHLORIDE | N204370 | ABBVIE INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-10-30 | Active | — | |
Allergan USA, Inc. et al v. Aurobindo Pharma Limited et al 2 patentsANDA 213932, 213982, 213984cariprazine | D. Del. | 2019-12-20 | Terminated 2022-06-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from HQ Pharma (Shanghai) Co., Ltd. FDA-2026-P-2443 HQ Pharma (Shanghai) Co., Ltd. filed this citizen petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA revise the Draft Guidance on Cariprazine Hydrochloride (RLD number 204370) to include product-specific guidance for cariprazine hydrochloride capsules at 0.5 mg and 0.75 mg s | Other | 2026-03-10 | Open | HQ Pharma (Shanghai) Co. |
Suitability Petition from HQ Pharma (Shanghai) Co., Ltd. FDA-2025-P-0332 HQ Pharma (Shanghai) Co., Ltd. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to pursue an Abbreviated New Drug Application for cariprazine hydrochloride orally disintegrating tablets in strengths of 1.5 mg, 3 mg, 4.5 mg, | Suitability | 2025-01-23 | Open | HQ Pharma (Shanghai) Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-14 | Dec 18, 2028 | Active |
| NPP | Dec 18, 2028 | Active |
| PED | Jun 18, 2029 | Active |