Prescription medicine
Eteplirsen Brand names: Exondys
Eteplirsen (Exondys) is a prescription medicine with an FDA approval on record since 2016. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the eteplirsen FDA label on DailyMed (effective August 13, 2025, Sarepta Therapeutics, Inc.); the NDA 206488 record on Drugs@FDA; every eteplirsen label on DailyMed.
Highlights of the record
FDA label of August 13, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEXONDYS 51 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 51 skipping.
Forms and strengths
- 50 mg/ml
Injection.
On the market
- Earliest approval on file
- September 19, 2016 Exondys 51, Sarepta Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- March 14, 2034 Exondys 51 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
- 2,391 through July 30, 2026
What is eteplirsen used for?
From the label: indications and usageEXONDYS 51 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 51 skipping. This indication is approved under accelerated approval based on an increase in dystrophin in skeletal muscle observed in some patients treated with EXONDYS 51 [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. EXONDYS 51 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 51 skipping. […]
FDA pharmacologic class: Antisense Oligonucleotide.
Source: FDA drug label (Exondys 51), Sarepta Therapeutics, Inc., effective August 13, 2025 (SPL set 33bff678-7829-479e-9110-b8e33a0bc0aa), via openFDA; the full label on DailyMed
Is there a generic for eteplirsen (Exondys)?
No generic eteplirsen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Exondys 51 injection, the last expiring on March 14, 2034. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 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 eteplirsen?
The FDA Adverse Event Reporting System holds 2,391 reports that list eteplirsen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 66 are coded as a death and 343 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?
- Other antisense oligonucleotides
- the pharmacologic class, with prices and generics
- Eteplirsen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other