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BOSULIF (BOSUTINIB MONOHYDRATE) | LOERadar
Viewing data from:
Latest
2026-07-01
2026-06-01
2026-05-01
2026-04-01
2026-03-28
2026-02-17
2026-02-10
2025-12-14
2025-02-26
2025-01-25
2024-11-08
2023-07-23
2023-06-15
2023-05-13
2023-01-26
2022-11-22
2022-10-28
2022-09-29
2022-07-09
2022-06-29
2022-04-08
2022-03-09
2021-12-28
2021-05-05
2021-03-12
2020-12-22
2020-11-12
2019-12-14
2019-09-15
BOSULIF
NDA
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BOSUTINIB MONOHYDRATE | N217729 | PF PRISM CV
2 strengths
4 unique patents
3 unique exclusivities
Patents
SEC Intel
Revenue
PTAB
Reexams
Litigation
Petitions
Trials
DMF
Approvals
Label
Products
Patent Timeline
4 unique patents, 2 exclusivities by expiration date
All strengths
EQ 50MG BASE
EQ 100MG BASE
Expired (2)
Expiring < 1yr (1)
Active (1)
Today
PED (+6 mo)
Exclusivity
2026
2027
2028
2029
2030
2031
2032
2033
2034
2035
Today
7417148
Jun. 11, 2026
7767678
May. 23, 2027
7919625
Jun. 11, 2026
11103497
Aug. 28, 2034
NP
Mar. 26, 2031
ODE-444
Mar. 26, 2031
PTAB Proceedings
No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board
Hatch-Waxman Litigation
No ANDA patent litigation cases (NOS 835) matched from PACER
Citizen Petitions
No FDA citizen petitions matched from Regulations.gov
Products (2)
Sort:
Name
↑
Applicant
Strength
Approval
#001 — EQ 50MG BASE
RLD
4 patents
3 exclusivities
▴
CAPSULE;ORAL | Approved: Sep 26, 2023
Patents (4)
Patent #
Expiration
PED
Drug Substance
Drug Product
Use Code
Delist
7417148
Dec 11, 2025
PED: Jun 11, 2026
PED
—
—
U-3707
A METHOD OF TREATING PATIENTS 1 YEAR OF AGE AND OLDER WITH CHRONIC PHASE PH+ CML, NEWLY-DIAGNOSED OR RESISTANT OR INTOLERANT TO PRIOR THERAPY
—
7767678
Nov 23, 2026
PED: May 23, 2027
PED
Yes
Yes
—
—
7919625
Dec 11, 2025
PED: Jun 11, 2026
PED
—
Yes
—
—
11103497
Feb 28, 2034
PED: Aug 28, 2034
PED
—
—
U-3216
A METHOD FOR TREATING A BCRABL POSITIVE LEUKEMIA IN A SUBJECT THAT IS RESISTANT TO IMATINIB COMPRISING ADMINISTERING TO THE SUBJECT A THERAPEUTICALLY EFFECTIVE AMOUNT OF BOSUTINIB, WHEREIN THE SUBJECT HAS A MUTATION IN THE BCRABL PROTEIN AT 949T>C
—
Exclusivities (3)
Code
Date
Status
NP
Sep 26, 2026
< 1 year
ODE-444
Sep 26, 2030
Active
PED
Mar 26, 2031
Active
#002 — EQ 100MG BASE
RLD
4 patents
3 exclusivities
▾
CAPSULE;ORAL | Approved: Sep 26, 2023