FDA Orange Book
Generic for Injectafer
Injectafer contains ferric carboxymaltose. 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
Yes. The generic name for Injectafer is ferric carboxymaltose. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Injectafer products the Orange Book lists.
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Injectafer products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG IRON/2ML (50MG IRON/ML) | Marketed (Rx) | AP | 1 | AP |
| solution, intravenous | 1GM IRON/20ML (50MG IRON/ML) | Marketed (Rx) | AP | 1 | AP |
| solution, intravenous | 500MG IRON/10ML (50MG IRON/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 750MG IRON/15ML (50MG IRON/ML) | Marketed (Rx) | AP | 1 | AP |
NDA 203565, held by AMERICAN REGENT INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic ferric carboxymaltose
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN PHARMACEUTICALS INC | 217769 | AP (A-rated, therapeutically equivalent) | June 25, 2026 | 100MG IRON/2ML (50MG IRON/ML) |
| MYLAN PHARMACEUTICALS INC | 217076 | AP (A-rated, therapeutically equivalent) | June 25, 2026 | 1GM IRON/20ML (50MG IRON/ML) |
| MYLAN LABORATORIES LTD | 212572 | AP (A-rated, therapeutically equivalent) | June 25, 2026 | 750MG IRON/15ML (50MG IRON/ML) |
Injectafer patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11478502 | January 8, 2027 | Method of use | U-3472 | 203565 |
| 11478502 | January 8, 2027 | Method of use | U-3473 | 203565 |
| 11478502 | January 8, 2027 | Method of use | U-3474 | 203565 |
| 11433091 | January 8, 2027 | Method of use | U-3435 | 203565 |
| 11433091 | January 8, 2027 | Method of use | U-3436 | 203565 |
| 11433091 | January 8, 2027 | Method of use | U-3437 | 203565 |
| 11433091 | January 8, 2027 | Method of use | U-3438 | 203565 |
| 11364260 | January 8, 2027 | Method of use | U-3637 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3115 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3050 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3116 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-1620 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3051 | 203565 |
| 11433091 | January 8, 2027 | Method of use | U-3634 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3635 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3316 | 203565 |
| 8895612 | January 8, 2027 | Method of use | U-3315 | 203565 |
| 7612109 | February 5, 2027 | Drug substance, Drug product | None | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-2555 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-2557 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-2556 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-3636 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-3313 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-3314 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-3312 | 203565 |
| 7754702 | February 15, 2028 | Method of use | U-1432 | 203565 |
Injectafer exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-915 | New indication | May 31, 2026 | 203565 |
Injectafer NDC codes
Questions
Is there a generic for Injectafer?
Yes. The generic name for Injectafer is ferric carboxymaltose. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Injectafer products the Orange Book lists.
What is the generic name for Injectafer?
The active ingredient in Injectafer is ferric carboxymaltose, per the FDA Orange Book.
When does the Injectafer patent expire?
The last patent listed for Injectafer in the Orange Book expires February 15, 2028. 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.