Prescription medicine
Casimersen Brand names: Amondys
Casimersen (Amondys) is a prescription medicine with an FDA approval on record since 2021. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the casimersen FDA label on DailyMed (effective January 9, 2026, Sarepta Therapeutics, Inc.); the NDA 213026 record on Drugs@FDA; every casimersen label on DailyMed.
Highlights of the record
FDA label of January 9, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageAMONDYS 45 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 45 skipping.
Forms and strengths
- 50 mg/ml
Injection.
On the market
- Earliest approval on file
- February 25, 2021 Amondys 45, Sarepta Theraps Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- November 12, 2030 Amondys 45 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
- 851 through July 30, 2026
What is casimersen used for?
From the label: indications and usageAMONDYS 45 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 45 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with AMONDYS 45 [see Clinical Studies ( 14 )]. Continued approval for this indication may be contingent upon verification of a clinical benefit in confirmatory trials. AMONDYS 45 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 45 skipping. […]
FDA pharmacologic class: Antisense Oligonucleotide.
Source: FDA drug label (AMONDYS 45), Sarepta Therapeutics, Inc., effective January 9, 2026 (SPL set e9e5fd44-eeda-4580-bba1-a734828bbcc3), via openFDA; the full label on DailyMed
Is there a generic for casimersen (Amondys)?
No generic casimersen is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 5 patents for Amondys 45 injection: the compound patent runs to November 12, 2030. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2021 earliest approval on file
- 2030 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 casimersen?
The FDA Adverse Event Reporting System holds 851 reports that list casimersen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 119 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
- Casimersen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other