Is there a generic for Ferric carboxymaltose?

The FDA Orange Book does not currently list an approved generic (ANDA) for Ferric carboxymaltose. It is available as 1 brand (NDA) application.

What is the reference-listed drug for Ferric carboxymaltose?

INJECTAFER (NDA 203565, AM REGENT) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

What patents protect Ferric carboxymaltose?

The Orange Book lists 6 patents against Ferric carboxymaltose products, with the earliest listed expiry in 2027. 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.

Does Ferric carboxymaltose have FDA marketing exclusivity?

Yes. The Orange Book records 4 marketing-exclusivity periods for Ferric carboxymaltose. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

What dosage forms of Ferric carboxymaltose are approved?

Ferric carboxymaltose is approved in the following dosage form: solution.

FDA Orange Book · active-ingredient family

Ferric carboxymaltose

Ferric carboxymaltose: 1 brand, 0 generics; first approved Jul 25, 2013; on patent until Jan 08, 2027.

On patent4 exclusivity periods

Generic status & protection

Protected until Jan 08, 2027 (earliest listed patent expiry).

Earliest patent expiry Jan 08, 2027Latest exclusivity ends May 31, 2026

Brands (NDA)

Generics (ANDA)

Listed patents

Next patent expiry

Jan 08, 2027

in 6 mo

Originator applications

Brand (NDA) products

INJECTAFERRLDRS

AM REGENTNDA 20356520214 strengths

Approved strengths under this FDA application.
Strength	Dosage form	Route	Status	TE
750MG IRON/15ML (50MG IRON/ML)	SOLUTION	INTRAVENOUS	Rx	—
500MG IRON/10ML (50MG IRON/ML)	SOLUTION	INTRAVENOUS	Rx	—
1GM IRON/20ML (50MG IRON/ML)	SOLUTION	INTRAVENOUS	Rx	—
100MG IRON/2ML (50MG IRON/ML)	SOLUTION	INTRAVENOUS	Rx	—

Protection horizon

Patent & exclusivity timeline

Patent expiryExclusivity endToday

Hatch-Waxman

Marketing exclusivity

Marketing exclusivity (4)

I-915New indication exclusivity (3 years)
May 31, 2026
2 mo ago
I-915New indication exclusivity (3 years)
May 31, 2026
2 mo ago
I-915New indication exclusivity (3 years)
May 31, 2026
2 mo ago
I-915New indication exclusivity (3 years)
May 31, 2026
2 mo ago

Orange Book patent file

Listed patents

Listed patents (6)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
11478502	Jan 08, 2027	in 6 mo	U-3472
11433091	Jan 08, 2027	in 6 mo	U-3435
11364260	Jan 08, 2027	in 6 mo	U-3637
8895612	Jan 08, 2027	in 6 mo	U-3115
7612109	Feb 05, 2027	in 7 mo	SubstanceProduct
7754702	Feb 15, 2028	in 1 yr 7 mo	U-2555

FDA approval span

Approval history

First approval

Jul 25, 2013

13 yr 2 mo ago

Most recent approval

Feb 04, 2022

4 yr 6 mo ago

Approvals span 2013–2022 across 1 FDA application.

Brand (NDA) 1100%

Generic (ANDA) 00%

Ferric carboxymaltose — 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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