TOLVAPTAN | N204441 | OTSUKA PHARMACEUTICAL CO LTD
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Otsuka Pharmaceutical Co., Ltd. v. MSN Pharmaceuticals Inc. et al 3 patentsANDA 219581tolvaptan | D. Del. | 2026-04-30 | Active | — |
| D. Del. | 2026-03-05 | Terminated 2026-04-15 | — | |
Otsuka Pharmaceutical Co., Ltd. v. Zenara Pharma Private Limited 3 patentsANDA 220377tolvaptan | D. Del. | 2026-02-19 | Active | — |
Otsuka Pharmaceutical Co., Ltd. v. Alkem Laboratories Ltd. 3 patentsANDA 220147tolvaptan | D. Del. | 2025-03-13 | Terminated 2026-01-22 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Clark Anderson FDA-2020-P-0763 · 5 docket documents Clark Anderson, an emeritus professor of medicine, filed this citizen petition on February 2, 2020, requesting that the FDA revoke approval of tolvaptan (NDA 204441) for treating autosomal dominant polycystic kidney disease. Anderson contends that the drug's efficacy is negligible due to flawed clin | Other | 2020-02-13 | Denied | Clark Anderson |
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under FDCA sections 505(j) and 505(q) requesting that FDA determine SAMSCA (tolvaptan) 60 mg tablets should be deemed withdrawn for safety reasons and refuse to approve any pending ANDAs with SAMSCA 60 mg as the reference listed drug, or su | 505(q) | 2019-08-26 | Denied | Otsuka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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.