Question 1

Is there a generic for Ferric maltol?

Accepted Answer

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

Question 2

What is the reference-listed drug for Ferric maltol?

Accepted Answer

ACCRUFER (NDA 212320, SHIELD TX) 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 maltol?

Accepted Answer

The Orange Book lists 3 patents against Ferric maltol products, with the earliest listed expiry in 2031. 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 maltol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 1 marketing-exclusivity period for Ferric maltol. 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 maltol are approved?

Accepted Answer

Ferric maltol is approved in the following dosage form: capsule.

Patent	Expires	In	Type
9248148	Mar 29, 2031	in 4 yr 10 mo	U-2603
10179120	Jan 06, 2035	in 8 yr 8 mo	U-2603
9802973	Oct 23, 2035	in 9 yr 6 mo	SubstanceProductU-2603

Ferric maltol

Brand (NDA) products · capsule

Marketing exclusivity (1)

Listed patents (3)

Ferric maltol — frequently asked questions

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.