PIMAVANSERIN TARTRATE | N207318 | ACADIA PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ACADIA Pharmaceuticals Inc. v. Zydus Lifesciences Limited et al 5 patentsANDA 214502pimavanserin tartrate | D. Del. | 2025-02-14 | Active | — |
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 5 patentsANDA 214493, 214502pimavanserin | D. Del. | 2020-07-30 | Terminated 2023-04-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Zydus Pharmaceuticals (USA), Inc FDA-2024-P-3881 Zydus Pharmaceuticals (USA), Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA determine that Pimavanserin Tablets, 34 mg is suitable for submission in an Abbreviated New Drug Application, with th | Suitability | 2024-08-14 | Open | Zydus Pharmaceuticals (USA) |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-2514 Zydus Pharmaceuticals (USA) Inc. filed this petition on May 22, 2024, requesting that the FDA determine whether NUPLAZID (pimavanserin) tablets, 17 mg (NDA N207318), held by Acadia Pharmaceuticals Inc., was withdrawn from commercial sale for reasons of safety or effectiveness or for commercial reaso | 505(q) | 2024-05-23 | Denied | Zydus Pharmaceuticals (USA) Inc. |
Suitability Petition from Zydus Pharmaceuticals (USA) Inc FDA-2024-P-0435 Zydus Pharmaceuticals (USA) Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that Pimavanserin Tablets 34 mg is suitable for submission in an Abbreviated New Drug Application, with ACADIA PHARMACEUTICALS INC' | Suitability | 2024-01-23 | Open | Zydus Pharmaceuticals (USA) Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
ACADIA Pharmaceuticals added a regulatory exclusivity designation (M-14 code) to NUPLAZID (pimavanserin tartrate) for NDA 207318.
New: New record
ACADIA Pharmaceuticals added pediatric exclusivity to NUPLAZID (pimavanserin tartrate) for NDA 207318, granting six months of regulatory exclusivity extension.
New: New record
New: New record
New: New record