Question 1

Is there a generic for Ferric carboxymaltose?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ferric carboxymaltose?

Accepted Answer

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

Question 3

What patents protect Ferric carboxymaltose?

Accepted Answer

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.

Question 4

Does Ferric carboxymaltose have FDA marketing exclusivity?

Accepted Answer

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.

Question 5

What dosage forms of Ferric carboxymaltose are approved?

Accepted Answer

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

Patent	Expires	In	Type
11478502	Jan 08, 2027	in 7 mo	U-3472
11433091	Jan 08, 2027	in 7 mo	U-3435
11364260	Jan 08, 2027	in 7 mo	U-3637
8895612	Jan 08, 2027	in 7 mo	U-3115
7612109	Feb 05, 2027	in 8 mo	SubstanceProduct
7754702	Feb 15, 2028	in 1 yr 8 mo	U-2555

Ferric carboxymaltose

Brand (NDA) products · solution

Marketing exclusivity (4)

Listed patents (6)

Ferric carboxymaltose — frequently asked questions

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