FDA Orange Book · active-ingredient family
Arimoclomol citrate
Arimoclomol citrate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MIPLYFFA · NDA 214927
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
8
Exclusivity periods
Brand (NDA) products · capsule
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MIPLYFFARLD×4 | ZEVRA DENMARK | NDA 214927 | — | Sep 20, 2024 |
Marketing exclusivity (8)
- 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
- 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
- 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
- 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 |
Arimoclomol citrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
