arimoclomol citrate · Zevra Denmark · NDA 214927
Miplyffa
Earliest generic entry, as listed · earliest of 4 marketed strengths
19 Nov 2041
Blocked by patent: US 11707456.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11707456 | drug substance, drug product, use U-4021 · sets the listed date | 19 Nov 2041 |
| US 11045460 | use U-4021 | 19 Aug 2029 |
| US 9289472 | use U-4021 | 11 Aug 2029 |
| US 9884058 | use U-4021 | 26 Jun 2029 |
Exclusivities · 2 unexpired
| ODE-496 | orphan drug (7 years) | 20 Sep 2031 |
| NCE | new chemical entity (5 years) | 20 Sep 2029 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 214927 · 001 · RLD | capsule, oral | EQ 47MG BASE | 19 Nov 2041 |
| 214927 · 002 · RLD | capsule, oral | EQ 62MG BASE | 19 Nov 2041 |
| 214927 · 003 · RLD | capsule, oral | EQ 93MG BASE | 19 Nov 2041 |
| 214927 · 004 · RLD | capsule, oral | EQ 124MG BASE | 19 Nov 2041 |