small molecule

PROVAYBLUE

METHYLENE BLUE

Loss of exclusivityJanuary 2027FDA regulatory exclusivity expiry
CompanyPROVEPHARM SAS

Drug detail

Brand namePROVAYBLUE
Active ingredientMETHYLENE BLUE
Strength50MG/10ML (5MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalApril 2016
Marketing statusRX

Regulatory exclusivity

CodeExpires
M-303January 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.

PROVAYBLUE patent cliff — loss of exclusivity January 2027 | CliffBio