Prescription medicine
Ferric maltol Brand names: Accrufer
Ferric maltol (Accrufer) is a prescription medicine with an FDA approval on record since 2019. No generic is listed; pharmacies paid $10.09 per Accrufer 30 mg capsule in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the ferric maltol FDA label on DailyMed (effective January 2, 2026, Shield TX (UK) Ltd); the NDA 212320 record on Drugs@FDA; every ferric maltol label on DailyMed.
Highlights of the record
FDA label of January 2, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
Forms and strengths
- 30 mg
Capsule.
On the market
- Earliest approval on file
- July 25, 2019 Accrufer, Shield Tx; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- October 23, 2035 Accrufer capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $10.09 per capsule Accrufer 30 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,038 through July 30, 2026
What is ferric maltol used for?
From the label: indications and usageACCRUFER is indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older. ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adult and pediatric patients 10 years of age and older.
FDA pharmacologic class: Parenteral Iron Replacement and Phosphate Binder.
Source: FDA drug label (ACCRUFER), Shield TX (UK) Ltd, effective January 2, 2026 (SPL set 367ac157-2d25-4f34-99ce-b126e0f03851), via openFDA; the full label on DailyMed
Is there a generic for ferric maltol (Accrufer)?
No generic ferric maltol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Accrufer capsules: the compound patent runs to October 23, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2035 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for ferric maltol (Accrufer)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.09 per Accrufer 30 mg capsule, up 6% from $9.54 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Accrufer 30 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Accrufer 30 mg capsule | Brand | $10.09 per capsule | $302.55 | +6% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the ferric maltol label say about other medicines?
The ferric maltol label names 2 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Ciprofloxacin | drug interactions | Oral Medications Concomitant use of ACCRUFER may decrease the bioavailability of some drugs, including mycophenolate, ethinyl estradiol, ciprofloxacin and doxycycline [see Clinical Pharmacology ( 12.3 )]. |
| Doxycycline | drug interactions | Oral Medications Concomitant use of ACCRUFER may decrease the bioavailability of some drugs, including mycophenolate, ethinyl estradiol, ciprofloxacin and doxycycline [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (ACCRUFER), Shield TX (UK) Ltd, effective January 2, 2026 (SPL set 367ac157-2d25-4f34-99ce-b126e0f03851), via openFDA; the full label on DailyMed
What do FAERS reports show for ferric maltol?
The FDA Adverse Event Reporting System holds 1,038 reports that list ferric maltol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 37 are coded as a death and 84 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other parenteral iron replacements
- the pharmacologic class, with prices and generics
- Ferric maltol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other