Prescription medicine
Omaveloxolone Brand names: Skyclarys
Omaveloxolone (Skyclarys) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the omaveloxolone FDA label on DailyMed (effective April 6, 2026, Biogen); the NDA 216718 record on Drugs@FDA; every omaveloxolone label on DailyMed.
Highlights of the record
FDA label of April 6, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageSKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
Forms and strengths
- 50 mg
Capsule.
On the market
- Earliest approval on file
- February 28, 2023 Skyclarys, Biogen Us; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- April 24, 2033 Skyclarys 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
- 1,695 through July 30, 2026
What is omaveloxolone used for?
From the label: indications and usageSKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older. SKYCLARYS is indicated for the treatment of Friedreich's ataxia in adults and adolescents aged 16 years and older.
Source: FDA drug label (SKYCLARYS), Biogen, effective April 6, 2026 (SPL set 2709e870-df3d-f30f-e063-6394a90aeda1), via openFDA; the full label on DailyMed
What does the patient leaflet for omaveloxolone say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking SKYCLARYS?Do not drink grapefruit juice or eat grapefruit. These may change the amount of SKYCLARYS in your blood.
From the patient leaflet: How should I store SKYCLARYS?Store SKYCLARYS at room temperature between 68°F to 77°F (20°C to 25°C) Keep SKYCLARYS and all medicines out of the reach of children.
Source: FDA drug label (SKYCLARYS), Biogen, effective April 6, 2026 (SPL set 2709e870-df3d-f30f-e063-6394a90aeda1), via openFDA; the full label on DailyMed
Is there a generic for omaveloxolone (Skyclarys)?
No generic omaveloxolone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 7 patents for Skyclarys capsules: the compound patent runs to April 24, 2033. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2033 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for omaveloxolone?
The FDA Adverse Event Reporting System holds 1,695 reports that list omaveloxolone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 80 are coded as a death and 428 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?
- Omaveloxolone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other