CliffBio
small molecule

AMONDYS 45

CASIMERSEN

Loss of exclusivityNovember 2030latest FDA-listed patent expiry
CompanySarepta Therapeutics →View the full company profile on CliffBio

Drug detail

Brand nameAMONDYS 45
Active ingredientCASIMERSEN
Strength100MG/2ML (50MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalFebruary 2021
Marketing statusRX

Listed patents

PatentExpiresType
9758783November 2030use U-3089
10781450November 2030use U-3089
10287586November 2030substance, product
9228187November 2030substance, product
RE48960February 2029substance, product

Regulatory exclusivity

CodeExpires
ODE-347February 2028
NCEFebruary 2026

More from Sarepta Therapeutics

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

AMONDYS 45 patent cliff — loss of exclusivity November 2030 | CliffBio