Orange Book product · Brand (NDA)
MONOFERRIC
FERRIC DERISOMALTOSE
At a glance
Jan 16, 2020
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 16, 2020
6 yr 6 mo ago
Today
Patent 10414831 expires
Listed drug substance patent expiration.
Mar 25, 2029
in 2 yr 10 mo
Patent 11851504 expires
Listed drug substance patent expiration.
Mar 25, 2029
in 2 yr 10 mo
Patent 12030962 expires
Listed drug substance patent expiration.
Mar 25, 2029
in 2 yr 10 mo
Patent 8815301 expires
Listed drug substance patent expiration.
Aug 14, 2029
in 3 yr 2 mo
Patent 11633489 expires
Listed method-of-use patent (U-3594) expiration.
Jun 22, 2036
in 10 yr 2 mo
Pharmaceutical detail
Active ingredient
FERRIC DERISOMALTOSE
Strength
1GM/10ML (100MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 208171
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10414831 | Mar 25, 2029 | in 2 yr 10 mo | SubstanceProduct |
| 11851504 | Mar 25, 2029 | in 2 yr 10 mo | SubstanceProduct |
| 12030962 | 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 |
