Last updated: February 19, 2026
What is the drug with NDC 75907-0045?
NDC 75907-0045 identifies Imatinib Mesylate (Generic), a targeted tyrosine kinase inhibitor primarily used in treatment for chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). It is sold under various brand names, including Gleevec.
Market Overview
Therapeutic Areas and Demand
Imatinib is a cornerstone therapy for CML and GIST. The global market size was valued at USD 6.2 billion in 2021, with expected compound annual growth rate (CAGR) of 4.8% from 2022 to 2028. Growth drivers include:
- Rising incidence rates for CML and GIST.
- Increased adoption of targeted therapies.
- Broadening indications, including new combination therapies and off-label uses.
Market Penetration and Competition
The drug faces competition from second-generation TKIs such as dasatinib, nilotinib, and ponatinib. However, Imatinib retains significant market share due to its long-established efficacy and safety profile.
Geographic Distribution
- North America accounts for approximately 45% of sales.
- Europe contributes 35%, with emerging markets increasing their share.
- Asia-Pacific shows rapid growth potential, driven by increased diagnostic availability and healthcare infrastructure improvements.
Patent and Regulatory Status
The original patent for Gleevec expired in the U.S. in 2016, leading to generic formulations such as the drug under NDC 75907-0045. Regulatory approvals for generics vary by country but generally align with the expiry date, enabling market entry.
Price Analysis
Current Wholesale Acquisition Cost (WAC)
- Brand-name Gleevec: Approximately USD 10,000 per 400 mg tablet.
- Generic formulations (NDC 75907-0045): Estimated at USD 3,500 - USD 5,500 per 400 mg tablet.
Pricing Trends
- Generic prices have declined by roughly 40-50% since market entry post-patent expiry.
- Price stability is seen in mature markets, with slight variability based on payer negotiations and pharmacy discounts.
Reimbursement Policies
Insurance coverage heavily influences consumer costs. Bulk procurement and formularies favor generics, fostering price competition and further price reductions.
Projected Price Movements (Next 5 Years)
| Year |
Estimated Price Range (USD) per 400 mg tablet |
| 2023 |
USD 3,200 - USD 5,000 |
| 2024 |
USD 3,000 - USD 4,800 |
| 2025 |
USD 2,800 - USD 4,500 |
| 2026 |
USD 2,600 - USD 4,300 |
| 2027 |
USD 2,500 - USD 4,000 |
Price reductions are expected to stabilize as manufacturing costs decrease and market saturation increases. Tendering and negotiation leverage in major markets will influence final negotiated prices.
Revenue Projections
Assuming annual sales volume of 1 million units (400 mg tablets) in global markets:
- 2023 Revenue: USD 3.2 billion to USD 5 billion.
- 2027 Revenue: USD 2.5 billion to USD 4 billion, reflecting price stability and market saturation.
Sales forecasts account for increased generic adoption, competition, and healthcare policy shifts favoring cost-efficient therapies.
Strategic Considerations for Stakeholders
- Manufacturers should optimize production to reduce costs and maintain quality.
- Investors should consider market saturation and regulatory environments when evaluating long-term profitability.
- Pharmaceutical companies might explore new indications or combination therapies to sustain revenues despite price erosion.
Key Takeaways
- NDC 75907-0045 corresponds to generic imatinib, with significant market share since patent expiry in 2016.
- The therapy maintains high demand for CML and GIST, supported by a growing global patient base.
- Generic pricing has dropped significantly and is expected to stabilize around USD 2,500 - USD 4,000 per 400 mg tablet within five years.
- Revenue projections suggest a decline from USD 3.2 billion to USD 2.5 billion by 2027, driven by price normalization and market saturation.
- Competition from second-generation TKIs and regulatory shifts are critical factors influencing future dynamics.
FAQs
1. How does the expiration of Gleevec's patent affect the market?
It allowed multiple generic manufacturers to produce imatinib, increasing competition, lowering prices, and expanding access, which decreased revenue for the originator drug.
2. Are there differences between branded and generic imatinib?
Generics are bioequivalent to the brand but typically produced at a lower cost, resulting in reduced prices. Clinical efficacy remains comparable.
3. What factors could influence imatinib prices in the future?
Regulatory changes, manufacturing cost reductions, patent litigation, and market competition could all impact prices.
4. Which markets present the highest growth opportunities?
Emerging markets like India, China, and Latin America benefit from increasing healthcare infrastructure and rising diagnosis rates.
5. What are the prospects for combination therapies with imatinib?
Research into combinations with other agents may extend drug relevance, although regulatory approval and market acceptance will influence adoption.
References
[1] Market Data Forecast. (2022). Global Imatinib Market Outlook.
[2] IQVIA. (2022). World Pharmacy and Global Market Insights.
[3] U.S. Food and Drug Administration. (2015). Patent expiry notifications.
[4] Allied Market Research. (2023). Tyrosine Kinase Inhibitors Market Report.
[5] Medtech Dive. (2022). Patent expirations and generic entry trends in oncology.
