FDA Orange Book · active-ingredient family
Ferric derisomaltose
Ferric derisomaltose is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MONOFERRIC · NDA 208171
1
Brand (NDA)
0
Generics (ANDA)
5
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MONOFERRICRLD×3 | PHARMACOSMOS | NDA 208171 | — | Jan 16, 2020 |
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12030962 | Mar 25, 2029 | in 2 yr 10 mo | SubstanceProduct |
| 10414831 | Mar 25, 2029 | in 2 yr 10 mo | SubstanceProduct |
| 11851504 | Mar 25, 2029 | in 2 yr 10 mo | SubstanceProduct |
| 8815301 | Aug 14, 2029 | in 3 yr 2 mo | SubstanceProductU-2734 |
| 11633489 | Jun 22, 2036 | in 10 yr 2 mo | U-3594 |
Ferric derisomaltose — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
