Bosutinib monohydrate
Bosutinib monohydrate: 2 brands, 2 generics; first approved Sep 04, 2012; generic available.
Generic available: 2 ANDA applications approved.
Brand (NDA) products
- BOSULIFRLDPF PRISM CVNDA 21772920232 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 50MG BASE CAPSULE ORAL Rx — EQ 100MG BASE CAPSULE ORAL Rx — - PF PRISM CVNDA 20334120123 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB EQ 400MG BASE TABLET ORAL Rx AB
Generic (ANDA) products (2)
- BOSUTINIB MONOHYDRATEMSNANDA 2096242026
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 400MG BASE TABLET ORAL Rx AB - BOSUTINIB MONOHYDRATEALEMBICANDA 20954320252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE EQ 100MG BASE TABLET ORAL Rx AB EQ 500MG BASE TABLET ORAL Rx AB
Patent & exclusivity timeline
Marketing exclusivity
- NPNew product exclusivity (3 years)
in 2 mo
- ODE-444Orphan-drug exclusivity (7 years)
in 4 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 4 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 8 mo
- NPNew product exclusivity (3 years)
in 2 mo
- ODE-444Orphan-drug exclusivity (7 years)
in 4 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 4 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 8 mo
- I-923New indication exclusivity (3 years)
in 2 mo
- ODE-444Orphan-drug exclusivity (7 years)
in 4 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 4 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 8 mo
- I-923New indication exclusivity (3 years)
in 2 mo
- ODE-444Orphan-drug exclusivity (7 years)
in 4 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 4 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 8 mo
- I-923New indication exclusivity (3 years)
in 2 mo
- ODE-444Orphan-drug exclusivity (7 years)
in 4 yr 2 mo
- PEDPediatric exclusivity (adds 6 months)
in 4 yr 8 mo
- PEDPediatric exclusivity (adds 6 months)
in 8 mo
Listed patents
| Patent | Expires | In | Type |
|---|---|---|---|
| 7417148 | 8 mo ago | U-3707 | |
| 7919625 | 8 mo ago | Product | |
| 7919625*PED | 2 mo ago | ||
| 7417148*PED | 2 mo ago | ||
| 7767678 | in 3 mo | SubstanceProduct | |
| 7767678*PED | in 10 mo | ||
| 11103497 | in 7 yr 8 mo | U-3216 | |
| 11103497*PED | in 8 yr 2 mo |
Approval history
Approvals span 2012–2026 across 4 FDA applications.
Bosutinib monohydrate: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
