ETELCALCETIDE | N208325 | KAI PHARMACEUTICALS INC A WHOLLY OWNED SUBSIDIARY OF AMGEN INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2023-01-12 | Terminated 2023-11-08 | — | |
| D. Del. | 2022-03-25 | Terminated 2023-11-14 | — | |
| D. Del. | 2022-02-22 | Terminated 2023-11-14 | — | |
| D. Del. | 2022-01-10 | Terminated 2023-11-08 | — | |
Amgen Inc. et al v. MSN Laboratories Private Limited et al 6 patentsANDA 215877etelcalcetide | D. Del. | 2021-05-19 | Terminated 2023-11-08 | — |
Amgen Inc. et al v. MSN Laboratories Private Limited, et al. 2 patentsANDA 215840etelcalcetide | D. Del. | 2021-05-06 | Terminated 2023-11-14 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, PC FDA-2017-P-4409 · 5 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require Synergy Pharmaceuticals to revise the approved package insert for Trulance (plecanatide), an NDA 208745 product approved January 19, 2017 for chronic idiopathic constipation in adults. The petitio | Other | 2017-07-25 | Partially Denied | Hyman, Phelps & McNamara, PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.