FERRIC CITRATE | A212563 | TEVA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Keryx Biopharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. 13 patentsANDA 212563Ferric Citrate | D. Del. | 2018-12-19 | Terminated 2020-05-04 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Keryx Biopharmaceuticals, Inc. FDA-2018-P-3284 · 22 docket documents Keryx Biopharmaceuticals, Inc. filed this citizen petition under 21 USC 355 requesting that FDA recognize that Auryxia (ferric citrate) oral tablets qualifies for five years of new chemical entity exclusivity and three years of exclusivity for a new indication approved in 2017, require ANDAs referen | 505(q) | 2018-08-27 | Denied | Keryx Biopharmaceuticals, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.