small molecule

BLUDIGO

INDIGOTINDISULFONATE SODIUM

Loss of exclusivityDecember 2037latest FDA-listed patent expiry
CompanyPROVEPHARM SAS

Drug detail

Brand nameBLUDIGO
Active ingredientINDIGOTINDISULFONATE SODIUM
Strength40MG/5ML (8MG/ML)
Dosage formSOLUTION
RouteINTRAVENOUS
ModalitySmall molecule
FDA approvalJuly 2022
Marketing statusRX

Listed patents

PatentExpiresType
10927258December 2037substance
11499050December 2037substance
11845867November 2036substance

Regulatory exclusivity

CodeExpires
NCEJuly 2027

Source: FDA Orange Book, layered on the CliffBio company graph. Cliff dates are the latest FDA-listed patent expiry; estimates are projections, not legal advice.

BLUDIGO patent cliff — loss of exclusivity December 2037 | CliffBio