Last updated: February 23, 2026
What is NDC 59417-0116?
NDC 59417-0116 corresponds to Bosutinib, marketed under the brand name Bosulif by Pfizer. It is an oral kinase inhibitor used primarily for treating chronic myelogenous leukemia (CML). Approved by the FDA in 2012, Bosutinib is designated for adult patients with Philadelphia chromosome-positive CML who are resistant or intolerant to prior therapy.
Market Overview
Market Size and Demand
The global CML therapeutics market was valued at approximately $3.2 billion in 2022 and is projected to reach $4.8 billion by 2030, growing at a CAGR of around 5.1% [1]. Bosutinib's role as a second-generation TKI positions it as a niche, but crucial, component within this market segment.
Key factors influencing demand include:
-
Patient prevalence: Estimated at 8,000 to 10,000 yearly diagnoses in the U.S., with an increasing population of CML patients experiencing resistance or intolerance to first-line therapies [2].
-
Treatment guidelines: The NCCN recommends TKI options like Bosutinib after failure of first-line treatments such as Imatinib.
-
Market penetration: Competed predominantly with Dasatinib, Nilotinib, and Ponatinib.
Competitive Landscape
| Drug |
Market Share (2022) |
Approved Indications |
Price Range (per 30-day supply) |
| Bosutinib (Bosulif) |
~25% |
Resistant/Intolerant CML |
$12,000 - $16,000 |
| Dasatinib |
~30% |
Frontline, resistant cases |
$11,500 - $15,500 |
| Nilotinib |
~20% |
Frontline, resistant cases |
$12,000 - $17,000 |
| Ponatinib |
~15% |
T315I mutation, resistant cases |
$17,500 - $22,000 |
Note: Market shares are approximate and vary by region.
Regulatory and Market Access Factors
Bosutinib faces pricing pressures from payers, with formulary restrictions favoring lower-cost generics or preferred TKIs. Insurance coverage favors drugs with established efficacy profiles and lower adverse event rates, influencing Bosutinib's sales volume.
Price Projections
Current Pricing (2023)
The average wholesale price (AWP) for Bosutinib is approximately $13,500 per month, equating to $162,000 annually for a typical patient [3].
Projected Price Trends (2024-2030)
| Year |
Estimated AWP (per Month) |
Key Drivers |
| 2024 |
$13,500 - $14,000 |
Inflation, R&D costs, payer negotiations |
| 2025 |
$13,800 - $14,200 |
Patent expiration on key markets, biosimilar entry delayed |
| 2026 |
$14,200 - $14,500 |
Increased market competition, patent challenges |
| 2028 |
$14,500 - $15,000 |
Introduction of lower-cost generics or biosimilars in select regions |
| 2030 |
$15,000 - $16,000 |
Worldwide pricing adjustments, value-based pricing models |
Price Sensitivity Factors
- Patents expiration: Protections in the U.S. expire in 2025, risking increased generic competition.
- Market penetration: Growing adoption could offset price reductions through higher sales volumes.
- Healthcare policies: Increasing push for cost containment could suppress prices.
Revenue Forecasts
Assuming stable demand of approximately 8,000 patients annually in the U.S., with an average annual cost of ~$162,000, the market potential for Bosutinib in the U.S. market is approximately $1.3 billion annually.
Globally, with access in Europe, Asia-Pacific, and Latin America, total revenues could reach $2.5 billion to $3 billion by 2030, assuming steady market share growth.
Key Considerations for Investment and R&D
- Patent expiration timelines influence pricing and market share.
- Innovations in combination therapy could expand indications and elevate pricing.
- Biosimilar entry in 2025 could significantly reduce prices, especially outside the U.S.
Key Takeaways
- NDC 59417-0116 (Bosutinib) is a second-generation TKI with a niche but growing market in resistant or intolerant CML.
- Current prices are around $13,500/month, with trends peaking at $15,000–$16,000 by 2030.
- Revenue potential remains high, but patent cliffs and biosimilar competition pose risks.
- Market growth depends on expanding indications, evolving treatment guidelines, and reimbursement policies.
FAQs
Q1: How soon will patent expiry affect pricing for Bosutinib?
A1: U.S. patents are set to expire in 2025, likely leading to increased generic competition and downward pressure on prices.
Q2: Are biosimilars impacting the Bosutinib market?
A2: Not yet; biosimilars are more relevant for biologic drugs. Bosutinib is a small-molecule kinase inhibitor, so generic versions may enter after patent expiration, potentially reducing prices.
Q3: What regions offer the highest pricing potential for Bosutinib?
A3: The U.S. maintains the highest prices due to insurance structures and market access policies, followed by certain European countries with favorable reimbursement schemes.
Q4: How might new treatment options influence Bosutinib’s market share?
A4: Launch of next-generation TKIs with superior efficacy or safety profiles could reduce Bosutinib’s market share, especially if priced competitively.
Q5: What strategies could protect Bosutinib’s revenue post-patent?
A5: Diversifying indications, developing combination therapies, and securing value-based agreements with payers can mitigate revenue loss.
References
[1] MarketsandMarkets. (2022). Global CML therapeutics market report.
[2] National Cancer Institute. (2021). Chronic Myelogenous Leukemia statistics.
[3] Red Book. (2023). Pharmaceutical Pricing and Market Data.
