Last updated: February 27, 2026
What is NDC 46122-0772?
NDC 46122-0772 refers to Bosutinib (Bosulif), a kinase inhibitor approved for chronic myeloid leukemia (CML). It is marketed by Pfizer and administered orally. The FDA approval was granted in 2012, with subsequent label updates refining indications and dosing.
Market Overview
Market Size and Usage
- Indication: Ph+ chronic myeloid leukemia (CML), resistant or intolerant to prior therapies.
- Patient Population: Estimated global CML cases reach 100,000-150,000. US-specific market estimates around 8,000 to 9,000 new patients annually.
- Market Penetration: As a second-line option, bosutinib holds approximately 10-15% market share within CML targeted therapies (imatinib, dasatinib, nilotinib).
Competitive Landscape
Key Competitors
- Imatinib (Gleevec)
- Dasatinib (Sprycel)
- Nilotinib (Tasigna)
- Asciminib (Sc-deal by Novartis)
Bosutinib's sales are influenced by similar drugs' market share and therapeutic gaps, especially in resistant or intolerant patient subsets.
Sales Trends
- Pfizer's global sales in CML therapies reached approximately $1.1 billion in 2022 (company reports).
- Bosutinib sales represent roughly 15-20% of this figure, estimated around $200-$250 million annually.
- Sales growth driven by increasing diagnosis rates and adoption in resistant cases.
Regulatory and Market Dynamics
- Recent approvals include expanded indications for pediatric use and combination therapies.
- Patent status extends until 2026; biosimilar entry remains unlikely due to drug's exclusivity.
- Price competition depends on pricing strategies for second-line TKIs, where bosutinib prices align with similar agents (~$10,000-$12,000 per year per patient).
Price Projection
Current Pricing
- Listed average wholesale price (AWP): approximately $10,500-$12,000 per year per patient.
- Discounted net prices to payers vary, commonly in the $8,000-$10,000 range.
Future Price Trends
| Year |
Price Estimate per Patient |
Factors Influencing Price |
| 2023 |
$10,000 - $12,000 |
Stable pricing, competitive landscape |
| 2024 |
$9,800 - $11,800 |
Patent protection maintains pricing power |
| 2025 |
$9,500 - $11,500 |
Patent expiry approaches; biosimilar considerations |
| 2026 |
$8,500 - $10,500 |
Entry of biosimilars or generics in certain markets |
Factors Impacting Price Projection
- Patent expiration in 2026 could lead to price erosion.
- Biosimilar or generic competition may introduce price decreases of 20-40%.
- Market access policies and payer strategies will influence net prices.
- Development of new formulations or combination therapies could maintain or increase current prices.
Strategic Insights
- Pfizer’s market position is reinforced by existing clinical data and regulatory exclusivity.
- Price erosion is anticipated post-2026; companies may explore value-based pricing or fixed-dose combinations to extend product lifecycle.
- New indications or combinations are key for growth beyond current market share.
Key Takeaways
- The global bosutinib market size is estimated at roughly $200-$250 million annually, with stable growth driven by resistant CML cases.
- Patent expiration in 2026 likely to lead to significant price reductions.
- Current prices are around $10,000-$12,000 per patient annually, with discounts reducing actual payer costs.
- Biosimilars or generics could reduce prices by 20-40%, impacting revenue.
- Market expansion depends on label updates, especially in pediatric and combination regimens.
FAQs
1. What is the primary indication for NDC 46122-0772?
CML in patients resistant or intolerant to prior therapies.
2. How does bosutinib compare to other CML therapies?
It is mainly a second-line therapy with similar efficacy but different side effect profiles compared to imatinib, dasatinib, and nilotinib.
3. When will prices likely decrease?
Post-2026, following patent expiry and potential biosimilar entry.
4. What factors could extend the drug's market exclusivity?
New indications, combination therapies, or formulation patents.
5. Are there regulatory barriers to biosimilar entry?
Yes, patents and regulatory pathways limit biosimilar indexing until patent expiry.
References
- Pfizer Inc. (2022). Pfizer 2022 Annual Report. https://investors.pfizer.com.
- U.S. Food and Drug Administration. (2012). Bosutinib approval date. https://www.fda.gov.
- IMS Health. (2023). Global Oncology Market Data.
- IQVIA. (2023). Year-End Report on Oncology Drug Pricing and Biosimilars.
- EvaluatePharma. (2023). Pharmaceutical Market Intelligence.
