Orange Book product · Brand (NDA)
MIPLYFFA
ARIMOCLOMOL CITRATE
At a glance
Sep 20, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
4
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 20, 2024
1 yr 9 mo ago
Today
Patent 9884058 expires
Listed method-of-use patent (U-4021) expiration.
Jun 26, 2029
in 3 yr 1 mo
Patent 9289472 expires
Listed method-of-use patent (U-4021) expiration.
Aug 11, 2029
in 3 yr 2 mo
Patent 11045460 expires
Listed method-of-use patent (U-4021) expiration.
Aug 19, 2029
in 3 yr 3 mo
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Sep 20, 2029
in 3 yr 4 mo
Exclusivity ends · ODE-496
Orphan-drug exclusivity (7 years)
Sep 20, 2031
in 5 yr 4 mo
Patent 11707456 expires
Listed drug substance patent expiration.
Nov 19, 2041
in 15 yr 8 mo
Pharmaceutical detail
Active ingredient
ARIMOCLOMOL CITRATE
Strength
EQ 47MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 214927
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (2)
- NCENew chemical entity exclusivity (5 years)
Sep 20, 2029
in 3 yr 4 mo
- ODE-496Orphan-drug exclusivity (7 years)
Sep 20, 2031
in 5 yr 4 mo
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9884058 | Jun 26, 2029 | in 3 yr 1 mo | U-4021 |
| 9289472 | Aug 11, 2029 | in 3 yr 2 mo | U-4021 |
| 11045460 | Aug 19, 2029 | in 3 yr 3 mo | U-4021 |
| 11707456 | Nov 19, 2041 | in 15 yr 8 mo | SubstanceProductU-4021 |
