Data updated: Mar 10, 2026
MIPLYFFA
ARIMOCLOMOL CITRATE
Approved 2024-09-20
1
Indication
--
Phase 3 Trials
1
Priority Reviews
1
Years on Market
Details
- Status
- Prescription
- First Approved
- 2024-09-20
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MIPLYFFA Approval History
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What MIPLYFFA Treats
1 FDA approvalsOriginally approved for its first indication in 2024 .
- Other (1)
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MIPLYFFA FDA Label Details
ProMIPLYFFA Patents & Exclusivity
Latest Patent: Aug 2029
Exclusivity: Sep 2031
Patents (48 active)
US11045460
Expires Aug 19, 2029
US9289472
Expires Aug 11, 2029
US9884058
Expires Jun 26, 2029
+ 38 more patents
Exclusivity
NCE
Until Sep 2029
ODE-496
Until Sep 2031
NCE
Until Sep 2029
ODE-496
Until Sep 2031
NCE
Until Sep 2029
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.