TIPIRACIL HYDROCHLORIDE; TRIFLURIDINE | N207981 | TAIHO ONCOLOGY INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-10-20 | Terminated 2024-04-03 | — | |
Taiho Pharmaceutical Co., Ltd. et al v. MSN Laboratories Private Ltd. et al 1 patentANDA 214024trifluridine and tipiracil (α,α,α-trifluorothymidine (FTD) and 5-chloro-6-[(2-iminopyrrolidine-1-yl)methyl]pyrimidine-2,4(1H,3H)-dione hydrochloride) | D. Del. | 2023-01-03 | Active | — |
Taiho Pharmaceutical Co., Ltd. et al v. Eugia Pharma Specialities, Ltd. et al 2 patentsANDA 213893trifluridine and tipiracil | D. Del. | 2022-12-20 | Terminated 2024-04-03 | — |
| D. Del. | 2022-11-10 | Terminated 2024-04-11 | — | |
Taiho Pharmaceutical Co., Ltd. et al v. MSN Laboratories Private Ltd. et al 1 patentANDA 214036trifluridine and tipiracil | D. Del. | 2021-06-09 | Active | — |
Taiho Pharmaceutical Co., Ltd. et al v. Natco Pharma Ltd. et al 3 patentsANDA 214008trifluridine and tipiracil | D. Del. | 2019-12-30 | Terminated 2024-04-11 | — |
| D. Del. | 2019-12-23 | Terminated 2025-01-31 | — | |
| D. Del. | 2019-12-20 | Terminated 2024-04-02 | — | |
Taiho Pharmaceutical Co., Ltd. et al v. Eugia Pharma Specialities Ltd. et al 2 patentsANDA 213893trifluridine and tipiracil | D. Del. | 2019-12-19 | Terminated 2024-04-03 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Kleinfeld Kaplan Becker (on behalf of Taiho Oncology, I... FDA-2022-P-0155 · 5 docket documents Kleinfeld Kaplan Becker filed this citizen petition on behalf of Taiho Oncology, Inc., the NDA holder for Lonsurf (trifluridine and tipiracil) tablets. Taiho requests that FDA refuse to approve any ANDA for generic trifluridine and tipiracil tablets that omit the pharmacokinetic information and dosa | 505(q) | 2022-02-10 | Granted | Taiho Oncology, Inc. |
Citizen Petition from Foley & Lardner LLP on behalf of Taiho Oncology, Inc. FDA-2020-P-1312 · 4 docket documents Foley & Lardner LLP on behalf of Taiho Oncology, Inc. filed this petition under Section 505(b) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any ANDA or 505(b)(2) application for a generic version of Lonsurf Tablets (trifluridine/tipiracil) that carves ou | 505(q) | 2020-05-01 | Open | Taiho Oncology, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.