What Diseases Are Listed in Bosulif Patents?
Bosulif (bosutinib), a tyrosine kinase inhibitor from Pfizer, targets chronic myeloid leukemia (CML). Its core patents cover methods of treating CML, particularly Philadelphia chromosome-positive (Ph+) CML in adults with resistant or intolerant cases.[1] US Patent 7,342,013 (expires 2024, with pediatric exclusivity to 2025) claims bosutinib for "inhibiting BCR-ABL kinase" in CML patients.[2]
Does Coverage Extend Beyond CML?
Primary patents focus on CML subtypes:
- Newly diagnosed Ph+ CML in chronic phase.
- Resistant or intolerant Ph+ CML after other therapies.
No broad claims for other diseases like acute myeloid leukemia or solid tumors appear in key patents; bosutinib's FDA approval is CML-only.[1][2] Some later patents (e.g., US 8,680,100, expires 2027) refine CML dosing but stick to leukemia indications.[3]
When Do Key Bosulif Patents Expire?
| Patent | Number | Expiration | Coverage Notes |
|--------|--------|------------|---------------|
| Composition of matter | US 7,342,013 | Jan 2024 (pediatric extension to 2025) | Bosutinib for BCR-ABL inhibition in CML [2] |
| Method of treatment | US 8,476,399 | May 2027 | CML chronic phase dosing [3] |
| Formulation | US 9,505,737 | Various to 2032 | Improved bioavailability for CML [3] |
Generics face Paragraph IV challenges; several ANDAs target 2025 entry post-pediatric exclusivity.[3]
Are There Patents for Other Indications or Combinations?
Secondary patents cover CML combos (e.g., with hydroxyurea) but not new diseases. No listed coverage for non-CML cancers or non-oncology uses in DrugPatentWatch data.[3] Ongoing litigation (e.g., Pfizer vs. generics) centers on CML method claims.[3]
How Does This Affect Generic Competition?
Bosulif exclusivity ends ~2025 for core CML use, opening biosimilar/ANDA pathways despite formulation patents lingering to 2032. Check DrugPatentWatch.com for latest Paragraph IV filings and settlement details.[3]
Sources
[1] FDA Label for Bosulif
[2] US Patent 7,342,013
[3] DrugPatentWatch.com - Bosulif