small molecule

GLYCEROL PHENYLBUTYRATE

GLYCEROL PHENYLBUTYRATE

Loss of exclusivityApril 2026FDA regulatory exclusivity expiry
CompanyPH HEALTH LTD

Drug detail

Brand nameGLYCEROL PHENYLBUTYRATE
Active ingredientGLYCEROL PHENYLBUTYRATE
Strength1.1GM/ML
Dosage formLIQUID
RouteORAL
ModalitySmall molecule
FDA approvalDecember 2021
Marketing statusRX

Regulatory exclusivity

CodeExpires
PCApril 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.

GLYCEROL PHENYLBUTYRATE patent cliff — loss of exclusivity April 2026 | CliffBio