Prescription medicine
Viltolarsen Brand names: Viltepso
Viltolarsen (Viltepso) is a prescription medicine with an FDA approval on record since 2020. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the viltolarsen FDA label on DailyMed (effective July 16, 2025, NS Pharma, Inc.); the NDA 212154 record on Drugs@FDA; every viltolarsen label on DailyMed.
Highlights of the record
FDA label of July 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping.
Forms and strengths
- 250 mg
Injection (solution).
On the market
- Earliest approval on file
- August 12, 2020 Viltepso, Nippon Shinyaku; Drugs@FDA’s file, where older or withdrawn approvals can be missing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 3, 2034 Viltepso injection; 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
- 165 through July 30, 2026
What is viltolarsen used for?
From the label: indications and usageVILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. […]
Source: FDA drug label (Viltepso), NDA212154 (Nippon Shinyaku), as published by NS Pharma, Inc., effective July 16, 2025 (SPL set 1ffff9a8-6d6a-4dcb-8493-1b6cc3a5d123), via openFDA; the full label on DailyMed
Is there a generic for viltolarsen (Viltepso)?
No generic viltolarsen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 2 patents for Viltepso injection: the compound patent runs to April 3, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2020 earliest approval on file
- 2034 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 viltolarsen?
The FDA Adverse Event Reporting System holds 165 reports that list viltolarsen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 7 are coded as a death and 40 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Viltolarsen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other