Orange Book product · Brand (NDA)
ACCRUFER
FERRIC MALTOL
At a glance
Jul 25, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2019
7 yr ago
Today
Exclusivity ends · NPP
New patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
Patent 9248148 expires
Listed method-of-use patent (U-2603) expiration.
Mar 29, 2031
in 4 yr 10 mo
Patent 10179120 expires
Listed method-of-use patent (U-2603) expiration.
Jan 06, 2035
in 8 yr 8 mo
Patent 9802973 expires
Listed drug substance patent expiration.
Oct 23, 2035
in 9 yr 6 mo
Pharmaceutical detail
Active ingredient
FERRIC MALTOL
Strength
30MG IRON
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 212320
Product number
001
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.
Marketing exclusivity (1)
- NPPNew patient population exclusivity (3 years)
Dec 19, 2028
in 2 yr 6 mo
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9248148 | Mar 29, 2031 | in 4 yr 10 mo | U-2603 |
| 10179120 | Jan 06, 2035 | in 8 yr 8 mo | U-2603 |
| 9802973 | Oct 23, 2035 | in 9 yr 6 mo | SubstanceProductU-2603 |
