FERRIC CITRATE | N205874 | KERYX BIOPHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-07-31 | Terminated 2021-11-15 | — | |
| D. Del. | 2019-05-10 | Terminated 2020-10-05 | — | |
Keryx Biopharmaceuticals, Inc. et al v. Chemo Research S.L. et al 14 patentsANDA 212738Ferric Citrate | D. Del. | 2019-02-01 | Terminated 2021-03-26 | — |
Keryx Biopharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. 13 patentsANDA 212563Ferric Citrate | D. Del. | 2018-12-19 | Terminated 2020-05-04 | — |
Keryx Biopharmaceuticals, Inc. et al v. Lupin Ltd. et al 14 patentsANDA 212537Ferric Citrate | D. Del. | 2018-12-13 | Terminated 2020-10-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Keryx Biopharmaceuticals, Inc. FDA-2018-P-3284 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 |
Citizen Petition from Sidley Austin LLP (Vifor Fresenius Medical Care Renal P... FDA-2017-P-4334 Sidley Austin LLP, on behalf of Vifor Fresenius Medical Care Renal Pharma Ltd., submitted a citizen petition under 21 C.F.R. § 10.30 on June 30, 2017, requesting that the FDA refuse to approve Keryx Biopharmaceuticals' supplemental NDA for Auryxia (ferric citrate) seeking to add an indication for tr | 505(q) | 2017-07-24 | Withdrawn | Sidley Austin LLP (Vifor Fresenius Medical Care Renal Pharma Ltd) |
Citizen Petition from Sidley Austin LLP (Vifor Fresenius Medical Care Renal P... FDA-2017-P-4023 Sidley Austin LLP, on behalf of Vifor Fresenius Medical Care Renal Pharma Ltd., filed this citizen petition under 21 C.F.R. § 10.30 requesting that the FDA refuse to approve Keryx Biopharmaceuticals' supplemental NDA for Auryxia (ferric citrate) for treatment of iron deficiency anemia in non-dialysi | 505(q) | 2017-07-03 | Withdrawn | Sidley Austin LLP (Vifor Fresenius Medical Care Renal Pharma Ltd) |
Source: Regulations.gov. FDA citizen petitions matched by application number.