Viewing data from:

FERRIC CARBOXYMALTOSE

ANDA

FERRIC CARBOXYMALTOSE | A212572 | MYLAN LABORATORIES LTD

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: INJECTAFER(TE code: AP)

Hatch-Waxman Litigation

2 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
PHARMACOSMOS HOLDING A/S et al v. MYLAN LABORATORIES LTD. 2:2026cv04946 2 patentsANDA 212572ferric carboxymaltose	D.N.J.	2026-05-01	Active	—
VIFOR (INTERNATIONAL) AG et al v. MYLAN LABORATORIES LTD. 3:2020cv01647 5 patentsANDA 212572ferric carboxymaltose	D.N.J.	2020-02-14	Terminated 2020-02-24	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain12 active DMFs1 inactive

12 active API suppliers hold Drug Master Files for this ingredient.

LEK PHARMACEUTICALS DDFERRIC CARBOXYMALTOSE

DMF 324372018

MATRIX PHARMACORP PRIVATE LTDFERRIC CARBOXYMALTOSE

DMF 330382018

FORMOSA LABORATORIES INCFERRIC CARBOXYMALTOSE

DMF 354422020

BRIGHTGENE BIO-MEDICAL TECHNOLOGY CO LTDFERRIC CARBOXYMALTOSE

DMF 373892022

INTERQUIM SAFERRIC CARBOXYMALTOSE

DMF 380062024

CHONGQING CARELIFE PHARMACEUTICAL CO LTDFERRIC CARBOXYMALTOSE

DMF 380622023

DR REDDYS LABORATORIES LTDFERRIC CARBOXYMALTOSE

DMF 382042023

APICORE LLCFERRIC CARBOXYMALTOSE

DMF 405532024

ZHEJIANG LIAOYUAN PHARMACEUTICALS CO LTDFERRIC CARBOXYMALTOSE

DMF 415972025

ZHEJIANG KINGLAND PHARMACEUTICAL CO LTDFERRIC CARBOXYMALTOSE

DMF 421392025

KREATIVE ORGANICS PRIVATE LTDFERRIC CARBOXYMALTOSE

DMF 423022025

SNJ LABS PVT LTDFERRIC CARBOXYMALTOSE

DMF 426382025

APICORE LLCInactiveFERRIC CARBOXYMALTOSE

DMF 367952022

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 22, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 750MG IRON/15ML (50MG IRON/ML)

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Jun 25, 2026

No patent or exclusivity listings for this strength.