FERRIC CITRATE | N205874 | KERYX BIOPHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2019-07-31 | Terminated 2021-11-15 | — | |
| D. Del. | 2019-05-23 | Terminated 2019-09-09 | — | |
| 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 Latham & Watkins LLP FDA-2023-P-3878 · 4 docket documents Par Pharmaceutical, Inc., represented by Latham & Watkins LLP, filed this citizen petition under 21 C.F.R. §§ 10.25(a) and 10.30 requesting that the FDA update its public list of Paragraph IV Certifications to reflect Par's ANDA 208217 for ferric citrate tablets 210 mg, which Par claims was the sole | 505(q) | 2023-09-11 | Withdrawn | Latham & Watkins LLP |
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. |
Citizen Petition from Sidley Austin LLP (Vifor Fresenius Medical Care Renal P... FDA-2017-P-4334 · 41 docket documents 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 | Denied | 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 · 40 docket documents 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.
Highest NADAC/Unit
$7.48
per ea
Lowest NADAC/Unit
$6.37
per ea
Brand NDCs
1
Generic NDCs
1
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 59922063101AURYXIA 210 MG TABLET | $7.48 | EA | Brand | $6.37 | 2026-02-18 |
| 00378289520FERRIC CITRATE 210 MG TABLET | $6.37 | EA | Generic | — | 2026-04-22 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.