CARFILZOMIB | A209330 | BRECKENRIDGE PHARMACEUTICAL INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical, Inc. 3 patentsANDA 209330carfilzomib | D. Del. | 2019-01-11 | Terminated 2019-05-16 | — |
Onyx Therapeutics, Inc. v. Breckenridge Pharmaceutical Inc. 9 patentsANDA 209330carfilzomib | D. Del. | 2016-10-27 | Terminated 2019-05-16 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
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.
No patent or exclusivity listings for this strength.