small molecule

ROMIDEPSIN

ROMIDEPSIN

Loss of exclusivityDecember 2026FDA regulatory exclusivity expiry
CompanyAMNEAL EU LTD

Drug detail

Brand nameROMIDEPSIN
Active ingredientROMIDEPSIN
Strength27.5MG/5.5ML (5MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalJune 2026
Marketing statusRX

Regulatory exclusivity

CodeExpires
CGTDecember 2026

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the FDA regulatory exclusivity expiry; estimates are projections, not legal advice.