Prescription medicine
Migalastat Brand names: Galafold
Migalastat (Galafold) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the migalastat FDA label on DailyMed (effective August 28, 2025, Amicus Therapeutics US, LLC); the NDA 208623 record on Drugs@FDA; every migalastat label on DailyMed.
Highlights of the record
FDA label of August 28, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageGALAFOLD is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ( GLA ) variant based on in vitro assay data [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1) ].
Forms and strengths
- 123 mg
Capsule.
On the market
- Earliest approval on file
- August 10, 2018 Galafold, Amicus Therap Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 11, 2042 Galafold capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 534 through July 30, 2026
What is migalastat used for?
From the label: indications and usageGALAFOLD is indicated for the treatment of adults with a confirmed diagnosis of Fabry disease and an amenable galactosidase alpha gene ( GLA ) variant based on in vitro assay data [see Dosage and Administration (2.1) and Clinical Pharmacology (12.1) ]. This indication is approved under accelerated approval based on reduction in kidney interstitial capillary cell globotriaosylceramide (KIC GL-3) substrate [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. […]
Source: FDA drug label (Galafold), Amicus Therapeutics US, LLC, effective August 28, 2025 (SPL set 66dbd928-0f1c-48b1-a832-54e4abd9f1db), via openFDA; the full label on DailyMed
Is there a generic for migalastat (Galafold)?
No generic migalastat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 66 patents for Galafold capsules: the compound patent runs to March 17, 2039, and the last listed entry to January 11, 2042. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2042 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the migalastat label say about other medicines?
The migalastat label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Caffeine | drug interactions | Drugs on GALAFOLD Co-administration of GALAFOLD with caffeine decreases migalastat AUC and C max [see Clinical Pharmacology (12.3) ] which may reduce GALAFOLD efficacy. |
Source: FDA drug label (Galafold), Amicus Therapeutics US, LLC, effective August 28, 2025 (SPL set 66dbd928-0f1c-48b1-a832-54e4abd9f1db), via openFDA; the full label on DailyMed
What do FAERS reports show for migalastat?
The FDA Adverse Event Reporting System holds 534 reports that list migalastat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 71 are coded as a death and 172 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Migalastat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other