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FERRIC CITRATE

ANDA

FERRIC CITRATE | A212563 | TEVA PHARMACEUTICALS USA INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: AURYXIA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Keryx Biopharmaceuticals, Inc. et al v. Teva Pharmaceuticals USA, Inc. 1:2018cv02012 13 patentsANDA 212563Ferric Citrate	D. Del.	2018-12-19	Terminated 2020-05-04	—

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

API Supply Chain10 active DMFs

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

PANION AND BF BIOTECH INCFERRIC CITRATE

DMF 160562002

NURAY CHEMICALS PVT LTDFERRIC CITRATE

DMF 281752014

TAPI NL BVFERRIC CITRATE

DMF 290832015

LUPIN MANUFACTURING SOLUTIONS LTDFERRIC CITRATE

DMF 303472016

BIOPHORE INDIA PHARMACEUTICALS PVT LTDFERRIC CITRATE

DMF 308352016

WEST BENGAL CHEMICAL INDUSTRIES LTDFERRIC CITRATE

DMF 321742017

COHANCE LIFESCIENCES LTDFERRIC CITRATE

DMF 336742019

APICORE LLC (A WHOLLY OWNED SUB OF RK PHARMA INC)FERRIC CITRATE

DMF 356222025

LUPIN MANUFACTURING SOLUTIONS LTDFERRIC CITRATE (PROCESS-B)

DMF 376052023

PANION AND BF BIOTECH INCFERRIC CITRATE (PROCESS 2)

DMF 408372024

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 9, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 210MG IRON

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Mar 11, 2026

No patent or exclusivity listings for this strength.