small molecule

CARBAGLU

CARGLUMIC ACID

Loss of exclusivityJanuary 2028FDA regulatory exclusivity expiry
CompanyRecordati Rare Diseases Inc.See this company's full patent-cliff portfolio

Drug detail

Brand nameCARBAGLU
Active ingredientCARGLUMIC ACID
Strength200MG
Dosage formTABLET, FOR SUSPENSION
RouteORAL
ModalitySmall molecule
FDA approvalMarch 2010
Marketing statusRX

Regulatory exclusivity

CodeExpires
ODE-345January 2028

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

CARBAGLU patent cliff — loss of exclusivity January 2028 | CliffBio