← Patent-cliff monitor small molecule AMONDYS 45 CASIMERSEN
Loss of exclusivity November 2030 latest FDA-listed patent expiry
Drug detail Brand name AMONDYS 45 Active ingredient CASIMERSEN Strength 100MG/2ML (50MG/ML) Dosage form SOLUTION Route INTRAVENOUS Modality Small molecule FDA approval February 2021 Marketing status RX
Listed patents Patent Expires Type 9758783 November 2030 use U-3089 10781450 November 2030 use U-3089 10287586 November 2030 substance, product 9228187 November 2030 substance, product RE48960 February 2029 substance, product
Regulatory exclusivity Code Expires ODE-347 February 2028 NCE February 2026
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.