Last updated: February 24, 2026
What is NDC 24208-0290?
NDC 24208-0290 refers to Imatinib Mesylate, marketed as Gleevec (brand name), used primarily for treating chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST), and other cancers. It is developed by Novartis and approved by the FDA since 2001.
Market Size and Usage
Imatinib is a leading targeted therapy with a significant market share in oncology. It has a well-established patient population. Key market data:
- Global Oncology Drugs Market (2022): Valued at approximately USD 250 billion.
- Imatinib Market Share: Estimated at USD 4-6 billion annually in sales globally.
- U.S. Market: Accounts for approximately 50-60% of global sales, roughly USD 2-3 billion annually.
- Patient Population (U.S.): About 10,000-12,000 CML patients receiving treatment, with continued demand from new diagnoses and expanded indications.
Competitive Landscape
Imatinib's primary competitors are other tyrosine kinase inhibitors (TKIs), including:
- Dasatinib (Sprycel)
- Nilotinib (Tasigna)
- Bosutinib (Bosulif)
- Asciminib (Scemblix)
Market entry barriers exist due to patent protections, but patent expirations and biosimilar options may influence prices.
Patent Timeline and Generic Entry
- Original Patent Expiration: 2016 (U.S.); patent protection expired or is expiring in multiple jurisdictions.
- Present Status: Generic versions approved in the U.S. since 2016, with varying market penetration across regions.
- Biosimilar Approvals: Pending or operational in some regions, increasing competition.
Price Trends and Projections
Historical Price Data
- Brand-Name Imatinib (Gleevec): Wholesale acquisition cost (WAC) in the U.S. around USD 8,000–$10,000 per month per patient.
- Post-Patent Generic Pricing (2016–2022): Prices declined by approximately 40–60%, with generics priced around USD 3,000–$5,000 per month.
Price Projections (2023–2028)
| Year |
Estimated Average Price (USD/month) |
Influencing Factors |
| 2023 |
$2,500–$4,000 |
Increased generic and biosimilar penetration, market saturation, price erosion. |
| 2024 |
$2,000–$3,500 |
Continued biosimilar approvals, insurance negotiations, regional variation. |
| 2025 |
$1,800–$3,000 |
Potential new biosimilar entries, patent challenges, pricing strategies. |
| 2026 |
$1,500–$2,500 |
Mature generic market, price stabilization. |
| 2027 |
$1,200–$2,000 |
Market saturation, competitive pricing, payor discounts. |
| 2028 |
$1,000–$1,800 |
Further biosimilar adoption, regional access increases. |
Market Dynamics Impacting Price
- Patent Expiry: Accelerates price declines, especially with generic options.
- Regulatory Approvals: Biosimilar approvals in key markets (EU, US) lead to potential price reductions.
- Reimbursement Policies: Favorable reimbursement can bolster prices; restrictive policies may pressure prices downward.
- Manufacturing and Supply Chain: Affect prices based on production costs and regional availability.
Regional Price Variations
- United States: Highest prices due to reimbursement and insurance coverage, but with downward pressure from generics.
- European Union: Slightly lower prices, faster generic uptake, and regional price controls.
- Emerging Markets: Prices are significantly lower ($500–$1,500/month), often subject to government-negotiated discounts.
Key Market Trends
- The decline of brand-name revenue correlates with patent expirations and biosimilar competition.
- The introduction of biosimilars does not always lead to proportionate price reductions given patent and regulatory complexities.
- Emerging markets continue to present growth opportunities due to expanding healthcare infrastructure and increasing cancer diagnosis and treatment rates.
Summary
The market for NDC 24208-0290 (Imatinib) is shifting from high-cost brand sales toward lower-cost generics and biosimilars. Prices are expected to decline steadily over the next five years, reaching USD 1,000–$1,800/month in developed markets, and lower globally. The overall market remains sizable, driven by existing patient populations and new treatment indications.
Key Takeaways
- Imatinib remains a multi-billion dollar market, primarily driven by the US and Europe.
- Patent expirations have significantly reduced prices, with generics dominating the landscape.
- Future pricing will be influenced heavily by biosimilar and generic market penetration, regional policies, and patent landscapes.
- Price declines of 70–80% are projected globally by 2028 from peak brand-name pricing.
FAQs
Q1: How soon will biosimilars fully compete with the originator?
A: Biosimilar competition is underway in some regions, with full market penetration expected within three to five years, depending on regulatory approvals and market acceptance.
Q2: Does the patent expiry mean the end of Imatinib's market?
A: No; while patent expiry allows generics to enter the market, branded Gleevec retains residual market share especially in regions with slower biosimilar adoption.
Q3: Are there legal or regulatory barriers to biosimilars?
A: Yes; biosimilars must meet regulatory standards similar to innovator drugs, which can delay market entry and influence pricing strategies.
Q4: Will new formulations or combination therapies affect prices?
A: Potentially, but these usually target specific patient subsets and may be priced higher, influencing overall affordability.
Q5: How does regional healthcare policy impact pricing?
A: Policies favoring price controls and negotiated discounts in regions like the EU and emerging markets tend to lower prices compared to the US.
References
[1] Marketdata LLC. (2022). Oncology Drugs Market Share and Sales Data.
[2] IQVIA. (2022). Global Oncology Market Trends.
[3] FDA. (2016). Approvals of Generic Imatinib Products.
[4] Novartis. (2022). Gleevec Patent & Market Information.
