FDA Orange Book
Is there a generic for Accrufer?
Accrufer contains ferric maltol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Accrufer (ferric maltol). The Orange Book shows its last listed patent expires October 23, 2035 and its last listed exclusivity ends December 19, 2028.
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Accrufer products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | 30MG IRON | Marketed (Rx) | None | 0 | None |
NDA 212320, held by SHIELD TX UK LTD. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Accrufer patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9248148 | March 29, 2031 | Method of use | U-2603 | 212320 |
| 10179120 | January 6, 2035 | Method of use | U-2603 | 212320 |
| 9802973 | October 23, 2035 | Drug substance, Drug product | U-2603 | 212320 |
Accrufer exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | December 19, 2028 | 212320 |
Accrufer NDC codes
Questions
Is there a generic for Accrufer?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Accrufer (ferric maltol). The Orange Book shows its last listed patent expires October 23, 2035 and its last listed exclusivity ends December 19, 2028.
What is the generic name for Accrufer?
The active ingredient in Accrufer is ferric maltol, per the FDA Orange Book.
When does the Accrufer patent expire?
The last patent listed for Accrufer in the Orange Book expires October 23, 2035. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.