FDA Orange Book · active-ingredient family
Bosutinib monohydrate
Bosutinib monohydrate is approved as 2 brand and 1 generic application in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
2
Brand (NDA)
1
Generics (ANDA)
8
Listed patents
20
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BOSULIFRLD×2 | PF PRISM CV | NDA 217729 | — | Sep 26, 2023 | |
| BOSULIFRLD×3 | PF PRISM CV | NDA 203341 | AB | Sep 04, 2012 |
Generic (ANDA) products (1)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BOSUTINIB MONOHYDRATE×2 | ALEMBIC | ANDA 209543 | AB | May 23, 2025 |
Marketing exclusivity (20)
- NPNew product exclusivity (3 years)
Sep 26, 2026
in 3 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
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
- NPNew product exclusivity (3 years)
Sep 26, 2026
in 3 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
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
- I-923New indication exclusivity (3 years)
Sep 26, 2026
in 3 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
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
- I-923New indication exclusivity (3 years)
Sep 26, 2026
in 3 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
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
- I-923New indication exclusivity (3 years)
Sep 26, 2026
in 3 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
- PEDPediatric exclusivity (adds 6 months)
Mar 26, 2027
in 9 mo
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7417148 | Dec 11, 2025 | 6 mo ago | U-3707 |
| 7919625 | Dec 11, 2025 | 6 mo ago | Product |
| 7919625*PED | Jun 11, 2026 | 8 d ago | |
| 7417148*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*PED | Aug 28, 2034 | in 8 yr 4 mo |
Bosutinib monohydrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
