FDA Orange Book
Is there a generic for Monoferric?
Monoferric contains ferric derisomaltose. 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 Monoferric (ferric derisomaltose). The Orange Book shows its last listed patent expires June 22, 2036.
Run it in Rivvi
Map Monoferric and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Monoferric products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 100MG/ML (100MG/ML) | Discontinued | None | 0 | None |
| solution, intravenous | 1GM/10ML (100MG/ML) | Marketed (Rx) | None | 0 | None |
| solution, intravenous | 500MG/5ML (100MG/ML) | Discontinued | None | 0 | None |
NDA 208171, held by PHARMACOSMOS AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Monoferric patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12030962 | March 25, 2029 | Drug substance, Drug product | None | 208171 |
| 10414831 | March 25, 2029 | Drug substance, Drug product | None | 208171 |
| 11851504 | March 25, 2029 | Drug substance, Drug product | None | 208171 |
| 8815301 | August 14, 2029 | Drug substance, Drug product | U-2734 | 208171 |
| 11633489 | June 22, 2036 | Method of use | U-3594 | 208171 |
Monoferric NDC codes
Questions
Is there a generic for Monoferric?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Monoferric (ferric derisomaltose). The Orange Book shows its last listed patent expires June 22, 2036.
What is the generic name for Monoferric?
The active ingredient in Monoferric is ferric derisomaltose, per the FDA Orange Book.
When does the Monoferric patent expire?
The last patent listed for Monoferric in the Orange Book expires June 22, 2036. 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.