small molecule

BRONCHITOL

MANNITOL

Loss of exclusivityOctober 2027FDA regulatory exclusivity expiry
CompanyPHARMAXIS EUROPE LTD

Drug detail

Brand nameBRONCHITOL
Active ingredientMANNITOL
Strength40MG
Dosage formPOWDER
RouteINHALATION
ModalitySmall molecule
FDA approvalOctober 2020
Marketing statusRX

Regulatory exclusivity

CodeExpires
ODE-327October 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.

BRONCHITOL patent cliff — loss of exclusivity October 2027 | CliffBio