CliffBio
small molecule

BOSULIF

BOSUTINIB MONOHYDRATE

Loss of exclusivityAugust 2034latest FDA-listed patent expiry
CompanyPF PRISM CV

Drug detail

Brand nameBOSULIF
Active ingredientBOSUTINIB MONOHYDRATE
StrengthEQ 100MG BASE
Dosage formTABLET
RouteORAL
ModalitySmall molecule
FDA approvalSeptember 2012
Marketing statusRX

Listed patents

PatentExpiresType
11103497*PEDAugust 2034—
11103497February 2034use U-3217
7767678*PEDMay 2027—
7767678November 2026substance, product
7417148*PEDJune 2026—
7919625*PEDJune 2026—
7919625December 2025product
7417148December 2025use U-3707

Regulatory exclusivity

CodeExpires
PEDMarch 2031
ODE-444September 2030
PEDMarch 2027
I-923September 2026

More from PF PRISM CV

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.

BOSULIF patent cliff — loss of exclusivity August 2034 | CliffBio