BENDAMUSTINE HYDROCHLORIDE | N205580 | EAGLE PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2016-00098 | 8791270 | IPR | Fresenius Kabi USA, LLC | Terminated-Settled | 2015-10-28 | — |
| IPR2016-00026 | 8791270 | IPR | AGILA SPECIALTIES INC. et al. | Institution Denied | 2015-10-09 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-01-17 | Active | — | |
Eagle Pharmaceuticals, Inc. v. Baxter Healthcare Corporation 2 patentsbendamustine hydrochloride | D. Del. | 2025-01-17 | Active | — |
| D. Del. | 2025-01-17 | Active | — | |
| D. Del. | 2024-01-17 | Active | — | |
| D. Del. | 2024-01-17 | Active | — | |
Eagle Pharmaceuticals, Inc. v. Accord Healthcare Inc. et al 1 patentBendamustine Hydrochloride | D. Del. | 2022-05-27 | Terminated 2022-11-21 | — |
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC et al 7 patentsBendamustine Hydrochloride | D. Del. | 2021-08-31 | Terminated 2022-10-25 | — |
| D. Del. | 2018-12-11 | Terminated 2019-05-09 | — | |
Eagle Pharmaceuticals, Inc. v. Slayback Pharma LLC 5 patentsANDA 212230bendamustine hydrochloride | D. Del. | 2018-09-20 | Terminated 2023-01-25 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Apotex Inc FDA-2022-P-3206 Apotex Inc. filed this citizen petition requesting that the FDA assign a therapeutic equivalence evaluation code of "AP" to Apotex's Bendamustine Hydrochloride Injection, 100 mg/4 mL (25 mg/mL), approved under NDA No. 215033 as a 505(b)(2) application, in relation to the reference listed drug Eagle | 505(q) | 2022-12-14 | Denied | Apotex Inc |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8609707 | Aug 11, 2031 | — | — | Yes | — | |
| 8791270 | Jan 12, 2026 | — | — | Yes | — | |
| 9265831 | Jan 28, 2031 | — | — | Yes | — | — |
| 9572796 | Jan 28, 2031 | — | — | Yes | — | |
| 9572797 | Jan 28, 2031 | — | — | — | — | |
| 10010533 | Jan 28, 2031 | — | — | Yes | — | — |
| 11103483 | Jan 28, 2031 | — | — | Yes | — | |
| 11844783 | Jan 28, 2031 | — | — | — | — | |
| 11872214 | Jan 28, 2031 | — | — | Yes | — | — |
| 12138248 | Jan 28, 2031 | — | — | Yes | — | — |
| 12350257 | Jan 28, 2031 | — | — | Yes | — |