Key Patents Covering Bosulif's Formula
Bosulif (bosutinib), a tyrosine kinase inhibitor from Pfizer for chronic myeloid leukemia, is protected by patents on its chemical composition, including the core compound formula (bosutinib monohydrate) and related salts. The primary U.S. composition-of-matter patent is US 7,342,013, which claims the bosutinib compound and its use in treating kinase-related disorders.[1][2]
When Does Bosulif's Main Patent Expire?
US 7,342,013 expires on August 30, 2027, after pediatric exclusivity extension. This patent directly covers the active ingredient's structure, blocking generic copies of the formula until then.[1][3]
Other Patents Protecting the Formula and Variants
- US 7,417,142: Covers bosutinib salts, including the monohydrate form used in Bosulif tablets, expiring April 13, 2029 (with extension).[1][2]
- US 8,486,979: Protects specific crystalline forms of bosutinib monohydrate, expiring March 26, 2029.[1]
Pfizer lists these as Orange Book patents for Bosulif (NDA 203,341), enforced against generics.[2]
Why Are Generic Challengers Targeting These Patents?
Companies like MSN Laboratories and Dr. Reddy's filed ANDAs with Paragraph IV challenges to US 7,342,013 and others, prompting Pfizer lawsuits. Courts upheld most claims, delaying approvals until 2027-2029.[1][3] Hatching exclusivity ends December 2029.[1]
Can Biosimilars or Other Entrants Bypass Formula Patents?
No biosimilars apply, as Bosulif is a small-molecule drug under 505(b)(2)/ANDA pathways. Formula patents block identical generics; alternatives would need new formulations, but none are approved yet.[2]
Sources:
[1]: DrugPatentWatch.com - Bosulif Patents
[2]: FDA Orange Book - Bosulif
[3]: DrugPatentWatch.com - Bosulif Expiry and Litigation