Last updated: March 21, 2026
What is the Drug Identified as NDC 00228-3316?
NDC 00228-3316 corresponds to Bosulif (bosutinib), developed by Pfizer. It is an oral kinase inhibitor approved for the treatment of Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) in adult patients who are resistant or intolerant to prior therapy. The drug was approved by the FDA in September 2012.
Market Overview
Therapeutic Area and Indications
Bosutinib addresses the chronic phase of Ph+ CML, a rare hematologic cancer accounting for approximately 15% of all leukemia cases. The projected global CML market is expected to grow from USD 1.2 billion in 2022 to USD 1.8 billion by 2027, representing a CAGR of 7.4%.[1]
Competitive Landscape
Bosutinib faces competition primarily from:
- Imatinib (Gleevec): First-line standard, with global sales exceeding USD 4.6 billion in 2022.
- Dasatinib (Sprycel): Second-generation, with sales of USD 2.2 billion.
- Nilotinib (Tasigna): With USD 1.4 billion in 2022 sales.
- Other emerging therapies and generics entering the market post-patent expiry.
Patent Status and Entry Barriers
Pfizer's key patents for Bosulif expire around 2025–2027, allowing for the potential entry of generic versions after this period. Patent litigation and biosimilar development could influence the timeline. Market exclusivity is a critical factor in revenue projections.
Market Penetration and Adoption
Bosutinib is positioned as a second- or third-line therapy for TKI-resistant patients. Its adoption depends on clinical efficacy, safety profile, and physician familiarity. Use constraints are linked to adverse effects such as diarrhea and myelosuppression.
Pricing Data
Current Pricing (U.S. Market)
As of Q4 2022, the wholesale acquisition cost (WAC) per 30-day supply of Bosulif is approximately USD 10,000.[2] This is comparable to other second-generation TKIs.
| Parameter |
Data |
| WAC per 30-day course |
USD 10,000 |
| Average annual treatment cost |
USD 120,000 (assuming 12 months of therapy) |
| Patient out-of-pocket (est.) |
USD 0–USD 4,000 (varies by insurance coverage) |
International Pricing
In Europe, price points are generally 20–30% lower than U.S. prices, with variable reimbursement models by country. In Canada, prices align with hospitals’ negotiated rates, averaging CAD 13,000 per month (~USD 10,000).
Price Projections
Short-term (Next 1–2 Years)
- Stable Pricing: No significant price change expected due to continued demand and existing reimbursement agreements.
- Market Pressure: Entry of generics post-2025 could reduce prices by 20–50% over 2–3 years, depending on market competition and regulatory approval timelines.
Long-term (Next 3–5 Years)
- Post-Patent Decline: Prices are projected to decline 30–50%, assuming generic availability.
- Discounted Prices: Biosimilar or generic versions could enter at 50–70% of original branded price, especially in major markets with large generic penetration.
Impact of Patent Expiry and Market Dynamics
| Year |
Price Reduction Expectation |
Explanation |
| 2025 |
10–20% decrease |
Near key patent expiry; market still consolidating |
| 2026–2027 |
30–50% decrease |
Increased generics/biosimilars availability |
Strategic Considerations
- Pfizer may pursue patent extensions or secure additional formulations.
- Adoption rates could be driven by clinical guidelines shifting towards targeted therapy.
- Price reductions are likely if clinical efficacy is comparable with cheaper generics.
Risks Impacting Market and Price
- Regulatory delays in generic approval.
- Patent litigation outcomes.
- Clinical trial results influencing treatment protocols.
- Competitive entry with superior efficacy or safety.
Key Takeaways
- NDC 00228-3316 (Bosulif) is a branded second-generation TKI targeting resistant or intolerant CML patients.
- Market sales total approximately USD 1–1.2 billion globally as of 2022.
- Current U.S. pricing approximates USD 10,000 per month.
- Generics expected post-2025 could lead to a 30–50% cut in prices within 3 years.
- Patent protections and market dynamics will determine pricing trajectories through 2027.
FAQs
1. What are the main competitors to bosutinib in the CML market?
Imatinib, dasatinib, and nilotinib constitute the main competitors, with second- and third-generation TKI therapies.
2. How might patent expiration affect bosutinib prices?
Patent expiration typically leads to generic entry, significantly reducing prices by 30–50% within 2–3 years.
3. Are there approved biosimilars for bosutinib?
Biosimilar development is limited given its small-molecule status; generics are expected to have greater impact after patent expiry.
4. How does international pricing compare to the U.S.?
Prices in Europe and Canada are approximately 20–30% lower, influenced by different reimbursement systems.
5. What factors could influence future market growth?
Advances in treatment protocols, regulatory approvals of new drugs, patent extensions, and evolving clinical guidelines.
References
[1] GlobalData. (2022). Chronic Myeloid Leukemia Market Analysis.
[2] Medicare Pricing Data. (2022). Bosulif (bosutinib) wholesale acquisition costs.
[3] FDA. (2012). Bosutinib approval announcement.
[4] IQVIA. (2022). Pharmaceutical Market Review.
