Acid dissociation constants calculated using MoKa v3.0.0
Dissociation level
Dissociation constant
Type (acidic/basic)
pKa1
8.74
Basic
pKa2
6.69
Basic
pKa3
4.74
Basic
Orange Book patent data (new drug applications)
Formulation strength
Trade name
Applicant
Application number
Approval date
Type
Dose form
Route
Patent number
Patent expiration date
Patent use
EQ 100MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
7417148
Dec. 11, 2025
A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 400MG BASE
BOSULIF
PF PRISM CV
N203341
Oct. 27, 2017
RX
TABLET
ORAL
7417148
Dec. 11, 2025
A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 500MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
7417148
Dec. 11, 2025
A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
EQ 100MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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
EQ 100MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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 F317L
EQ 400MG BASE
BOSULIF
PF PRISM CV
N203341
Oct. 27, 2017
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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
EQ 400MG BASE
BOSULIF
PF PRISM CV
N203341
Oct. 27, 2017
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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 F317L
EQ 500MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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
EQ 500MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
11103497
Feb. 28, 2034
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 F317L
Orange Book exclusivity data (new drug applications)
Formulation strength
Trade name
Applicant
Application number
Approval date
Type
Dose form
Route
Exclusivity date
Description
EQ 100MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
Dec. 19, 2024
TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
EQ 400MG BASE
BOSULIF
PF PRISM CV
N203341
Oct. 27, 2017
RX
TABLET
ORAL
Dec. 19, 2024
TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)
EQ 500MG BASE
BOSULIF
PF PRISM CV
N203341
Sept. 4, 2012
RX
TABLET
ORAL
Dec. 19, 2024
TREATMENT OF ADULT PATIENTS WITH NEWLY-DIAGNOSED CHRONIC PHASE (CP) PHILADELPHIA CHROMOSOME-POSITIVE CHRONIC MYELOGENOUS LEUKEMIA (PH+ CML)