TERIPARATIDE | N021318 | ELI LILLY AND CO
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ORBICULAR PHARMACEUTICAL TECHNOLOGIES PRIVATE LIMITED et al v. ELI LILLY AND COMPANY 1 patentANDA 215844Teriparatide | INSD | 2022-06-02 | Terminated 2022-10-21 | — |
Eli Lilly and Company v. Radius Health, Inc. 1 patentteriparatide [rDNA origin] injection; abaloparatide | D. Del. | 2021-07-08 | Terminated 2021-08-10 | — |
| INSD | 2021-06-29 | Terminated 2021-10-01 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Amneal Pharmaceuticals FDA-2017-P-6274 Amneal Pharmaceuticals filed this citizen petition pursuant to Section 505(j)(2)(C) and Section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA refrain from approving any Abbreviated New Drug Applications for synthetically derived Teriparatide injection products as generic | 505(q) | 2017-10-26 | Denied | Amneal Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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