Last updated: March 2, 2026
What is the Drug Associated with NDC 00245-0014?
The National Drug Code (NDC) 00245-0014 corresponds to Imatinib Mesylate (Gleevec). It is a targeted cancer therapy approved by the FDA primarily for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Imatinib is a first-generation tyrosine kinase inhibitor (TKI).
Current Market Size and Dynamics
Market Overview
- Global Market (2022): Estimated at $7 billion, driven by chronic myeloid leukemia (CML) treatments.
- Key Regions: U.S. dominates with approximately 45% market share, followed by Europe and Asia-Pacific.
- Growth Rate: Compound annual growth rate (CAGR) expected at 7% through 2027.
- Drivers of Growth:
- Expanding indications, including detailed use in dermatology, pediatric cancers, and other rare tumors.
- Increasing adoption of personalized medicine.
- Patent expirations leading to generic competition, but recent data shows sustained demand for branded versions.
Competitive Landscape
| Brand Name |
Developer |
Market Share (2022) |
Price (per 400 mg tablet) |
Key Features |
| Gleevec |
Novartis |
~70% |
$200 |
First FDA-approved TKI, established standard of care |
| Generic Imatinib |
Multiple manufacturers |
~25% |
$50–$80 |
Price under pressure but gaining market share |
Patent & Regulatory Environment
- Patent Expiry: The primary patent for Gleevec expired in the U.S. in 2016.
- Generics: Multiple manufacturers introduced biosimilar and generic versions.
- Regulatory Actions: FDA approved several generic versions, leading to price erosion.
Future Price Projections
| Year |
Estimated Average Price (per 400 mg tablet) |
Notes |
| 2023 |
$60–$80 |
Continued generic market penetration |
| 2025 |
$40–$60 |
Brand dominance expected to decline further; possible new formulations |
| 2030 |
$30–$50 |
Price stabilization at lower levels; increased biosimilar competition |
Factors Influencing Price Trends
- Patent Closedown: Loss of exclusivity typically causes a rapid price decline.
- Biosimilar Market Entry: Biosimilar versions are priced at 20-30% below the brand-name.
- Manufacturing Costs: Marginal decreases due to competition.
- New Formulations: Development of extended-release or combination therapies could affect pricing.
- Regulatory Changes: Reimbursement policies that favor biosimilars can influence prices downward.
Market Entry and Investment Considerations
- Emerging Markets: Rapid growth driven by increasing healthcare infrastructure and oncology treatment access.
- Patent Challenges & Litigation: Patent disputes can delay generic entry or extend premium pricing.
- Pipeline Developments: Numerous second- and third-generation TKIs are in clinical development, potentially impacting Imatinib's market share and pricing.
Summary of Price Projections
| Year |
Price Range (per 400 mg tablet) |
Market Dynamics |
| 2023 |
$60–$80 |
Generic competition is intensifying |
| 2025 |
$40–$60 |
Market saturates with biosimilars |
| 2030 |
$30–$50 |
Reduced prices with further biosimilar adoption |
Key Takeaways
- Imatinib (NDC 00245-0014) holds a significant market share within targeted cancer therapies.
- The market is increasingly saturated with generics, causing a notable price decline over time.
- Price erosion is expected to continue, stabilized by new formulations and market competition.
- Emerging markets present growth opportunities but with regulatory and reimbursement variability.
- Patent expiration and biosimilar competition are the primary drivers of future pricing trends.
FAQs
Q1: How does patent expiration affect the price of Imatinib?
Patent expiration enables generic manufacturers to enter the market, leading to price reductions of approximately 50-70%, depending on market competition.
Q2: Are there ongoing clinical trials that could impact Imatinib’s market?
Yes. Multiple trials are exploring second-generation TKIs and combination therapies, which could reduce Imatinib's market share.
Q3: What are the primary factors influencing Imatinib’s future market size?
Emerging biosimilars, regulatory policies, new therapeutic options, and expansion into rare indications.
Q4: How do biosimilars influence the pricing landscape?
They generally sell at 20-30% lower prices than the branded drug, increasing affordability and market penetration.
Q5: What is the outlook for Imatinib in Asia-Pacific markets?
High growth prospects due to expanding healthcare access, but pricing and reimbursement policies vary significantly by country.
References
- MarketWatch. (2022). Global cancer therapeutics market size.
- Novartis. (2022). Gleevec product information.
- IQVIA. (2022). Global oncology market trends.
- FDA. (2016). Approval of generic versions of Gleevec.
- EvaluatePharma. (2022). Oncology drug pipeline and market outlook.
