Orange Book product · Brand (NDA)
BOSULIF
BOSUTINIB MONOHYDRATE
At a glance
Sep 04, 2012
Approved
Brand (NDA)
Application
AB
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 04, 2012
14 yr ago
Patent 7417148 expires
Listed method-of-use patent (U-1283) expiration.
Dec 11, 2025
6 mo ago
Patent 7417148 expires
Listed method-of-use patent (U-3708) expiration.
Dec 11, 2025
6 mo ago
Patent 7417148 expires
Listed method-of-use patent (U-3707) expiration.
Dec 11, 2025
6 mo ago
Patent 7919625 expires
Listed drug product patent expiration.
Dec 11, 2025
6 mo ago
Patent 7417148*PED expires
Listed listed patent expiration.
Jun 11, 2026
8 d ago
Patent 7919625*PED expires
Listed listed patent expiration.
Jun 11, 2026
8 d ago
Today
Exclusivity ends · I-923
New indication exclusivity (3 years)
Sep 26, 2026
in 3 mo
Patent 7767678 expires
Listed drug substance patent expiration.
Nov 23, 2026
in 5 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
Patent 7767678*PED expires
Listed listed patent expiration.
May 23, 2027
in 11 mo
Exclusivity ends · ODE-444
Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 4 mo
Exclusivity ends · PED
Pediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 10 mo
Patent 11103497 expires
Listed method-of-use patent (U-3216) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 11103497 expires
Listed method-of-use patent (U-3217) expiration.
Feb 28, 2034
in 7 yr 10 mo
Patent 11103497*PED expires
Listed listed patent expiration.
Aug 28, 2034
in 8 yr 4 mo
Pharmaceutical detail
Active ingredient
BOSUTINIB MONOHYDRATE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 203341
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (4)
- I-923New indication exclusivity (3 years)
Sep 26, 2026
in 3 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
- ODE-444Orphan-drug exclusivity (7 years)
Sep 26, 2030
in 4 yr 4 mo
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2031
in 4 yr 10 mo
Listed patents (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7417148 | Dec 11, 2025 | 6 mo ago | U-1283 |
| 7417148 | Dec 11, 2025 | 6 mo ago | U-3708 |
| 7417148 | Dec 11, 2025 | 6 mo ago | U-3707 |
| 7919625 | Dec 11, 2025 | 6 mo ago | Product |
| 7417148*PED | Jun 11, 2026 | 8 d ago | |
| 7919625*PED | Jun 11, 2026 | 8 d ago | |
| 7767678 | Nov 23, 2026 | in 5 mo | SubstanceProduct |
| 7767678*PED | May 23, 2027 | in 11 mo | |
| 11103497 | Feb 28, 2034 | in 7 yr 10 mo | U-3216 |
| 11103497 | Feb 28, 2034 | in 7 yr 10 mo | U-3217 |
| 11103497*PED | Aug 28, 2034 | in 8 yr 4 mo |
