small molecule

LEGUBETI

ACETYLCYSTEINE LYSINE

Loss of exclusivityFebruary 2027FDA regulatory exclusivity expiry
CompanyGALEPHAR PHARMACEUTICAL RESEARCH INC

Drug detail

Brand nameLEGUBETI
Active ingredientACETYLCYSTEINE LYSINE
StrengthEQ 500MG BASE/PACKET
Dosage formFOR SOLUTION
RouteORAL
ModalitySmall molecule
FDA approvalFebruary 2024
Marketing statusDISCN

Regulatory exclusivity

CodeExpires
NPFebruary 2027

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

LEGUBETI patent cliff — loss of exclusivity February 2027 | CliffBio