AMONDYS 45

PeakRNA

casimersen

NDAINTRAVENOUSSOLUTIONPriority Review
Approved
Feb 2021
Lifecycle
Peak
Competitive Pressure
8/100

Mechanism of Action

45 of dystrophin pre-mRNA resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 45 skipping. Exon 45 skipping is intended to allow for production of an internally truncated dystrophin protein in patients with genetic mutations that…

Pharmacologic Class:

Antisense Oligonucleotide

Indications (1)

Duchenne muscular dystrophy (DMD) in patients

Loss of Exclusivity

LOE Date
Nov 12, 2030
57 months away
Patent Expiry
Nov 12, 2030
Exclusivity Expiry
Feb 25, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
RE48960
Feb 16, 2029
SubstanceProduct
U-3088
10287586
Nov 12, 2030
SubstanceProduct
—
10781450
Nov 12, 2030
U-3089
9228187
Nov 12, 2030
SubstanceProduct
—
9758783
Nov 12, 2030
U-3089
External Resources
DailyMed
Full prescribing information
FDA Drugs@FDA
FDA approval history
RxNorm
Drug nomenclature & identifiers