PIMAVANSERIN TARTRATE | N210793 | ACADIA PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited et al 3 patentsANDA 214782pimavanserin tartrate | D. Del. | 2022-10-21 | Active | — |
| D. Del. | 2022-10-21 | Terminated 2023-12-29 | — | |
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 4 patentsANDA 214493Pimavanserin tartrate | D. Del. | 2022-10-21 | Terminated 2023-04-05 | — |
ACADIA Pharmaceuticals Inc. v. MSN Laboratories Private Limited et al 2 patentsANDA 214925pimavanserin tartrate | D. Del. | 2020-07-30 | Terminated 2024-01-11 | — |
ACADIA Pharmaceuticals Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 5 patentsANDA 214493, 214502pimavanserin | D. Del. | 2020-07-30 | Terminated 2023-04-05 | — |
ACADIA Pharmaceuticals Inc. v. Hetero Labs Limited et al 3 patentsANDA 214828pimavanserin tartrate | D. Del. | 2020-07-30 | Terminated 2021-05-03 | — |
ACADIA Pharmaceuticals Inc. v. Aurobindo Pharma Limited et al 4 patentsANDA 214782pimavanserin tartrate | D. Del. | 2020-07-24 | Terminated 2024-05-07 | — |
| D. Del. | 2020-07-24 | Terminated 2024-05-07 | — |
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 · 7 docket documents 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 | Granted | Zydus Pharmaceuticals (USA), Inc |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. FDA-2024-P-2514 · 4 docket documents 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FDA determine whether NUPLAZID (pimavanserin) tablets, 17 mg (NDA N207318), held by Acadia Pharmaceuticals Inc., was withdrawn from commercial sale for reasons of safety or effectiveness or for commercial reaso | 505(q) | 2024-05-23 | Granted | Zydus Pharmaceuticals (USA) Inc. |
Suitability Petition from Zydus Pharmaceuticals (USA) Inc FDA-2024-P-0435 · 4 docket documents 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 | Denied | Zydus Pharmaceuticals (USA) Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$170.50
per ea
Lowest NADAC/Unit
$170.50
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63090034030NUPLAZID 34 MG CAPSULE | $170.50 | EA | Brand | — | 2026-03-18 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 7601740 | Apr 29, 2030PED: Oct 29, 2030 | PED | Yes | Yes | — | — |
| 7659285 | Aug 24, 2026 | — | — | — | — | |
| 7732615 | Jun 3, 2028PED: Dec 3, 2028 | PED | Yes | Yes | — | — |
| 10449185 | Aug 27, 2038PED: Feb 27, 2039 | PED | — | Yes | — | — |
| 10646480 | Aug 27, 2038PED: Feb 27, 2039 | PED | — | Yes | — | — |
| 10849891 | Aug 27, 2038PED: Feb 27, 2039 | PED | — | Yes | — | |
| 11452721 | Aug 27, 2038PED: Feb 27, 2039 | PED | — | Yes | — | — |
| Code | Date | Status |
|---|---|---|
| M-14 | Apr 27, 2029 | Active |
| PED | Oct 27, 2029 | Active |