CARFILZOMIB | N202714 | ONYX PHARMACEUTICALS INC A WHOLLY OWNED SUB OF AMGEN INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Onyx Therapeutics, Inc. v. Amneal Pharmaceuticals of New York, LLC et al 3 patentscarfilzomib | D. Del. | 2025-09-04 | Active | — |
| D. Del. | 2025-04-24 | Terminated 2025-10-03 | — | |
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc. 3 patentsANDA 209330carfilzomib | D. Del. | 2019-01-11 | Terminated 2019-05-16 | — |
Onyx Therapeutics, Inc. v. MSN Pharmaceuticals, Inc. et al 10 patentsANDA 209526carfilzomib | D. Del. | 2017-12-20 | Terminated 2019-05-08 | — |
Onyx Therapeutics, Inc. v. Dr. Reddys Laboratories, Inc et al. 8 patentsANDA 209422carfilzomib | D. Del. | 2017-12-18 | Terminated 2019-05-16 | — |
| D. Del. | 2017-11-22 | Terminated 2019-05-08 | — | |
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical Inc. 9 patentsANDA 209330carfilzomib | D. Del. | 2016-10-27 | Terminated 2019-05-16 | — |
| D. Del. | 2016-10-24 | Terminated 2023-02-21 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Qilu Pharmaceutical Co., Ltd. FDA-2015-P-1590 Qilu Pharmaceutical Co., Ltd., through its US agent Qilu Pharma, Inc., submitted this suitability petition under section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine that new strengths of 10mg/vial and 30mg/vial of Carfilzomib for injection are suitable f | Suitability | 2015-05-12 | Open | Qilu Pharmaceutical Co. |
Attachment 2 Proposed Package Labeling for Carfilzomib re Suitability Petitio... FDA-2015-P-1590 Qilu Pharmaceutical Co., Ltd. filed a petition requesting approval to market a carfilzomib formulation in the United States, submitting proposed package labeling as part of their suitability petition to demonstrate compliance with FDA requirements for the drug product. | Suitability | 2015-05-12 | Open | Qilu Pharmaceutical Co. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| M-14 | May 22, 2028 | Active |
| PED | Nov 22, 2028 | Active |