Is there a generic for Ferric citrate?

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ferric citrate, referencing the brand AURYXIA. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

What is the reference-listed drug for Ferric citrate?

AURYXIA (NDA 205874, KERYX BIOPHARMS) is the reference-listed drug, the approved product a generic applicant must show its version is the same as.

What patents protect Ferric citrate?

The Orange Book lists 3 patents against Ferric citrate products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

What dosage forms of Ferric citrate are approved?

Ferric citrate is approved in the following dosage form: tablet.

FDA Orange Book · active-ingredient family

Ferric citrate

Ferric citrate: 1 brand, 1 generic; first approved Sep 05, 2014; generic available.

Generic available

Generic status & protection

Generic available: 1 ANDA application approved.

Earliest patent expiry Apr 21, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Apr 21, 2026

4 mo ago

Brand (NDA) products

Originator applications

AURYXIARLDRS
KERYX BIOPHARMSNDA 2058742014
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 210MG IRON TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 210MG IRON	TABLET	ORAL	Rx	AB

Generic (ANDA) products (1)

Abbreviated applications

FERRIC CITRATE
TEVA PHARMS USAANDA 2125632026
Approved strengths under this FDA application.
Strength Dosage form Route Status TE
EQ 210MG IRON TABLET ORAL Rx AB

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
EQ 210MG IRON	TABLET	ORAL	Rx	AB

Patent & exclusivity timeline

Protection horizon

Patent expiryExclusivity endToday

Listed patents

Orange Book patent file

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
8093423	Apr 21, 2026	4 mo ago	U-1577
10300039	Jul 21, 2030	in 4 yr	U-2549
9387191	Jul 21, 2030	in 4 yr	Product

Approval history

FDA approval span

First approval

Sep 05, 2014

12 yr 2 mo ago

Most recent approval

Mar 11, 2026

6 mo ago

Approvals span 2014–2026 across 2 FDA applications.

Brand (NDA) 150%

Generic (ANDA) 150%

Ferric citrate: frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

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