CliffBio
small molecule

BOSUTINIB MONOHYDRATE

BOSUTINIB MONOHYDRATE

Loss of exclusivityDecember 2026FDA regulatory exclusivity expiry
CompanyAlembic →See this company's full patent-cliff portfolio

Drug detail

Brand nameBOSUTINIB MONOHYDRATE
Active ingredientBOSUTINIB MONOHYDRATE
StrengthEQ 500MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalMay 2025
Marketing statusRX

Regulatory exclusivity

CodeExpires
PCDecember 2026

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