FERRIC CARBOXYMALTOSE | N203565 | AMERICAN REGENT INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-01490 | 7754702 | IPR | Pharmacosmos A/S | Final Written Decision | 2015-06-24 | — |
| IPR2015-01495 | 8895612 | IPR | Pharmacosmos A/S | Institution Denied | 2015-06-24 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2026-05-01 | Active | — | |
PHARMACOSMOS HOLDING A/S et al v. DR. REDDY'S LABORATORIES, LTD. et al 2 patentsANDA 218848ferric carboxymaltose | D.N.J. | 2026-05-01 | Active | — |
VIFOR (INTERNATIONAL) AG et al v. XIROMED PHARMA ESPANA, S.L. et al 6 patentsANDA 220469ferric carboxymaltose | D.N.J. | 2025-11-21 | Active | — |
Vifor (International) AG et al v. Orbicular Pharmaceutical Technologies Private Limited 6 patentsANDA 212136ferric carboxymaltose | D.N.J. | 2025-10-20 | Active | — |
Vifor (International) AG et al v. Orbicular Pharmaceutical Technologies Pvt. Ltd. 5 patentsANDA 212136ferric carboxymaltose | D.N.J. | 2025-09-08 | Active | — |
Vifor (International) AG et al v. Orbicular Pharmaceutical Technologies Private Limited 6 patentsANDA 212136ferric carboxymaltose | D. Del. | 2025-08-21 | Terminated 2025-10-17 | — |
Vifor (International) AG et al v. Orbicular Pharmaceutical Technologies Pvt. Ltd. 5 patentsANDA 212136ferric carboxymaltose | D. Del. | 2025-05-02 | Terminated 2025-09-05 | — |
VIFOR (INTERNATIONAL) AG et al v. MSN LABORATORIES PRIVATE LIMITED et al 6 patentsANDA 219580ferric carboxymaltose | D.N.J. | 2025-04-25 | Terminated 2025-07-16 | — |
Vifor (International) AG et al v. Apotex Inc. et al 6 patentsANDA 219993ferric carboxymaltose | D. Del. | 2025-02-20 | Active | — |
AMERICAN REGENT, INC. v. MSN LABORATORIES PRIVATE LIMITED et al 1 patentANDA 219580ferric carboxymaltose | D.N.J. | 2024-11-22 | Active | — |
| D.N.J. | 2024-06-07 | Terminated 2024-06-07 | — | |
| D.N.J. | 2020-02-14 | Terminated 2020-02-24 | — | |
VIFOR (INTERNATIONAL) AG et al v. MYLAN LABORATORIES LTD. 5 patentsANDA 212572ferric carboxymaltose | D.N.J. | 2020-02-14 | Terminated 2020-02-24 | — |
| D.N.J. | 2019-08-02 | Terminated 2020-02-06 | — | |
| D.N.J. | 2019-06-18 | Terminated 2021-12-29 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Hyman, Phelps & McNamara, P.C. FDA-2025-P-6222 · 11 docket documents Law firm Hyman, Phelps & McNamara, P.C. filed this citizen petition requesting that the FDA require submission of a Prior Approval Supplement with bioequivalence testing when sponsors of carbohydrate-iron complex products such as ferric carboxymaltose, ferric derisomaltose, ferumoxytol, iron dextran | Other | 2025-11-17 | Open | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Scott E. Olitsky FDA-2025-P-1084 · 3 docket documents Scott E. Olitsky, a physician with Hereditary Hemorrhagic Telangiectasia, filed this citizen petition pursuant to 21 CFR § 10.30 requesting that the FDA issue a black box warning for ferric carboxymaltose regarding the risk of severe hypophosphatemia and its downstream complications including osteom | Other | 2025-04-15 | Open | Scott E. Olitsky |
Citizen Petition from Axinn Veltrop and Harkrider LLP FDA-2022-P-0144 · 32 docket documents On February 3, 2022, Chad A. Landmon of Axinn Veltrop and Harkrider LLP submitted a citizen petition requesting that the FDA deny supplemental New Drug Applications for Injectafer (ferric carboxymaltose injection) for labeling changes based on the FAIR-HF and CONFIRM-HF trials unless intended to str | Other | 2022-02-10 | Partially Denied | Axinn Veltrop and Harkrider LLP |
Citizen Petition from Sidley Austin LLP on behalf of Vifor Pharma FDA-2020-P-0158 · 6 docket documents Sidley Austin LLP, on behalf of Vifor Pharma, filed this citizen petition in January 2020 requesting that the FDA clarify that the ANDA pathway under Section 505(j) is inappropriate for follow-on harder-to-copy complex drugs and that approvals for such drugs must instead proceed under Section 505(b) | 505(q) | 2020-01-10 | Open | Vifor Pharma |
Citizen Petition from Luitpold Pharmaceuticals Inc. (Sheppard, Mullin, Richte... FDA-2013-P-1294 · 5 docket documents On September 30, 2013, Luitpold Pharmaceuticals Inc., through counsel at Sheppard Mullin Richter & Hampton LLP, filed a citizen petition requesting that the FDA approve any New Drug Application or supplement for injectable iron products treating iron deficiency anemia outside chronic kidney disease | 505(q) | 2013-11-15 | Denied | Luitpold Pharmaceuticals Inc. (Sheppard, Mullin, Richter & Hampton LLP) |
Source: Regulations.gov. FDA citizen petitions matched by application number.