FDA Orange Book
Is there a generic for Miplyffa?
Miplyffa contains arimoclomol. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Miplyffa (arimoclomol). The Orange Book shows its last listed patent expires November 19, 2041 and its last listed exclusivity ends September 20, 2031.
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Miplyffa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 124MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 47MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 62MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 93MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214927, held by ZEVRA DENMARK AS. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Miplyffa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9884058 | June 26, 2029 | Method of use | U-4021 | 214927 |
| 9289472 | August 11, 2029 | Method of use | U-4021 | 214927 |
| 11045460 | August 19, 2029 | Method of use | U-4021 | 214927 |
| 11707456 | November 19, 2041 | Drug substance, Drug product | U-4021 | 214927 |
Miplyffa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 20, 2029 | 214927 |
| ODE-496 | Orphan drug exclusivity | September 20, 2031 | 214927 |
Miplyffa NDC codes
Questions
Is there a generic for Miplyffa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Miplyffa (arimoclomol). The Orange Book shows its last listed patent expires November 19, 2041 and its last listed exclusivity ends September 20, 2031.
What is the generic name for Miplyffa?
The active ingredient in Miplyffa is arimoclomol, per the FDA Orange Book.
When does the Miplyffa patent expire?
The last patent listed for Miplyffa in the Orange Book expires November 19, 2041. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.