TOLVAPTAN | N022275 | OTSUKA PHARMACEUTICAL CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2024-06-21 | Terminated 2026-01-09 | — | |
| D. Del. | 2023-06-30 | Terminated 2023-09-27 | — | |
Otsuka Pharmaceutical Co., Ltd. v. Teva Pharmaceuticals, Inc. et al 3 patentsANDA 216933tolvaptan | D. Del. | 2022-04-22 | Terminated 2024-09-23 | — |
| D. Del. | 2022-03-10 | Terminated 2022-06-21 | — | |
| D. Del. | 2021-06-23 | Terminated 2024-08-07 | — | |
| D. Del. | 2018-06-29 | Terminated 2018-10-01 | — | |
| D. Del. | 2014-06-20 | Terminated 2015-09-23 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Otsuka Pharmaceutical Development & Commercialization, ... FDA-2019-P-4002 · 3 docket documents Otsuka Pharmaceutical Co., Ltd. filed this citizen petition under FDCA sections 505(j) and 505(q) requesting that FDA determine SAMSCA (tolvaptan) 60 mg tablets should be deemed withdrawn for safety reasons and refuse to approve any pending ANDAs with SAMSCA 60 mg as the reference listed drug, or su | 505(q) | 2019-08-26 | Denied | Otsuka Pharmaceutical Development & Commercialization, Inc. |
Citizen Petition from Gordon Johnston Regulatory Consultants LLC FDA-2016-P-0974 · 5 docket documents Gordon Johnston Regulatory Consultants LLC filed this petition on behalf of an interested party requesting that the FDA determine whether SAMSCA (Tolvaptan) Tablets, 60 mg, (NDA 022275) held by Otsuka America Pharma was voluntarily withdrawn from sale for reasons of safety or efficacy, as the produc | 505(q) | 2016-04-06 | Granted | Gordon Johnston Regulatory Consultants LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.