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  1. pharmadog
  2. ›drugs
  3. ›Bosutinib
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bosutinib

Marketedupdated 3mo ago
by Alembic Pharmaceuticals Inc
Approved
community read0 votes

🐶 often sniffed alongside

top 4
  • tagApproval48 co-mentions · 24 sources
  • drugBosulif47 co-mentions · 24 sources
  • drugBOSUTINIB MONOHYDRATE24 co-mentions · 24 sources
  • tagSmall Molecule24 co-mentions · 24 sources

all catalysts(0)

nothing on the calendar yet

Trials studying bosutinib

  • phase3Study of Efficacy of CML-CP Patients Treated With ABL001 Versus Bosutinib, Previously Treated With 2 or More TKIscompletedn=233
  • phase2iPSC-based Drug Repurposing for ALS Medicine (iDReAM) Studycompletedn=46
  • phase4Asciminib Roll-over Studyrecruitingn=347
  • phase3A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CPactive not recruitingn=405
  • phase2Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)recruitingn=720
  • phase2Bosutinib in Pediatric Patients With Newly Diagnosed Chronic Phase or Resistant/Intolerant Ph + Chronic Myeloid Leukemiaactive not recruitingn=60
  • phase3Study of Olverembatinib (HQP1351) in Patients With CP-CMLrecruitingn=285
  • phase1WI231696: Bosutinib, Palbocicilib and Fulvestrant for HR+HER2- Advanced Breast Cancer Refractory to a CDK4/6 Inhibitorcompletedn=19
more trials →

Patent cliff

source: FDA Orange Book
first barrier falls
Sep 26, 2026
37 days

Earliest of all listed patents + FDA exclusivities. Generic / biosimilar entry typically only becomes possible AFTER both patent and exclusivity barriers expire.

patents (40)

  • Aug 28, 2034patentUS 11103497*PED
  • Aug 28, 2034patentUS 11103497*PED
  • Aug 28, 2034patentUS 11103497*PED
  • Aug 28, 2034patentUS 11103497*PED
  • Aug 28, 2034patentUS 11103497*PED
  • Feb 28, 2034method-of-use (U-3217)US 11103497
  • Feb 28, 2034method-of-use (U-3217)US 11103497
  • Feb 28, 2034method-of-use (U-3217)US 11103497
  • Feb 28, 2034method-of-use (U-3217)US 11103497
  • Feb 28, 2034method-of-use (U-3217)US 11103497
  • May 23, 2027patentUS 7767678*PED276d
  • May 23, 2027patentUS 7767678*PED276d
  • May 23, 2027patentUS 7767678*PED276d
  • May 23, 2027patentUS 7767678*PED276d
  • May 23, 2027patentUS 7767678*PED276d
  • Nov 23, 2026compositionUS 776767895d
  • Nov 23, 2026compositionUS 776767895d
  • Nov 23, 2026compositionUS 776767895d
  • Nov 23, 2026compositionUS 776767895d
  • Nov 23, 2026compositionUS 776767895d
  • Jun 11, 2026patentUS 7417148*PED
  • Jun 11, 2026patentUS 7417148*PED
  • Jun 11, 2026patentUS 7417148*PED
  • Jun 11, 2026patentUS 7417148*PED
  • Jun 11, 2026patentUS 7417148*PED
  • Jun 11, 2026patentUS 7919625*PED
  • Jun 11, 2026patentUS 7919625*PED
  • Jun 11, 2026patentUS 7919625*PED
  • Jun 11, 2026patentUS 7919625*PED
  • Jun 11, 2026patentUS 7919625*PED
  • Dec 11, 2025method-of-use (U-3708)US 7417148
  • Dec 11, 2025method-of-use (U-3708)US 7417148
  • Dec 11, 2025method-of-use (U-3707)US 7417148
  • Dec 11, 2025method-of-use (U-3707)US 7417148
  • Dec 11, 2025method-of-use (U-3708)US 7417148
  • Dec 11, 2025formulationUS 7919625
  • Dec 11, 2025formulationUS 7919625
  • Dec 11, 2025formulationUS 7919625
  • Dec 11, 2025formulationUS 7919625
  • Dec 11, 2025formulationUS 7919625

FDA exclusivities (20)

  • Mar 26, 2031PEDPediatric (6mo bonus)4.6y
  • Mar 26, 2031PEDPediatric (6mo bonus)4.6y
  • Mar 26, 2031PEDPediatric (6mo bonus)4.6y
  • Mar 26, 2031PEDPediatric (6mo bonus)4.6y
  • Mar 26, 2031PEDPediatric (6mo bonus)4.6y
  • Sep 26, 2030ODE-444Orphan Drug (7y)4.1y
  • Sep 26, 2030ODE-444Orphan Drug (7y)4.1y
  • Sep 26, 2030ODE-444Orphan Drug (7y)4.1y
  • Sep 26, 2030ODE-444Orphan Drug (7y)4.1y
  • Sep 26, 2030ODE-444Orphan Drug (7y)4.1y
  • Mar 26, 2027PEDPediatric (6mo bonus)218d
  • Mar 26, 2027PEDPediatric (6mo bonus)218d
  • Mar 26, 2027PEDPediatric (6mo bonus)218d
  • Mar 26, 2027PEDPediatric (6mo bonus)218d
  • Mar 26, 2027PEDPediatric (6mo bonus)218d
  • Sep 26, 2026I-923Indication (3y)37d
  • Sep 26, 2026NPNP37d
  • Sep 26, 2026I-923Indication (3y)37d
  • Sep 26, 2026I-923Indication (3y)37d
  • Sep 26, 2026NPNP37d

News(0)

no news has mentioned this drug yet

brand
Bosutinib
generic
bosutinib
indication
Chronic Myelocytic Leukemia (CML, Chronic Myeloid Leukemia)
phase
marketed
Data sources
ClinicalTrials.gov
last refreshed 46m ago
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