Prescription medicine
Golodirsen Brand names: Vyondys
Golodirsen (Vyondys) is a prescription medicine with an FDA approval on record since 2019. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the golodirsen FDA label on DailyMed (effective March 13, 2025, Sarepta Therapeutics, Inc.); the NDA 211970 record on Drugs@FDA; every golodirsen label on DailyMed.
Highlights of the record
FDA label of March 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVYONDYS 53 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
- 50 mg/ml
Injection.
On the market
- Earliest approval on file
- December 12, 2019 Vyondys 53, Sarepta Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- June 28, 2028 Vyondys 53 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
- 435 through July 30, 2026
What is golodirsen used for?
From the label: indications and usageVYONDYS 53 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 VYONDYS 53 [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. VYONDYS 53 is an antisense oligonucleotide 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. […]
FDA pharmacologic class: Antisense Oligonucleotide.
Source: FDA drug label (Vyondys 53), Sarepta Therapeutics, Inc., effective March 13, 2025 (SPL set 35c227d1-5b24-44b0-b5d3-f0f6b1c46bd5), via openFDA; the full label on DailyMed
Is there a generic for golodirsen (Vyondys)?
No generic golodirsen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 1 patent for Vyondys 53 injection, the last expiring on June 28, 2028. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2019 earliest approval on file
- 2028 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 golodirsen?
The FDA Adverse Event Reporting System holds 435 reports that list golodirsen 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 67 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?
- Other antisense oligonucleotides
- the pharmacologic class, with prices and generics
- Golodirsen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other