Last updated: February 20, 2026
What is the drug associated with NDC 68001-0428?
The National Drug Code (NDC) 68001-0428 corresponds to Gleevec (generic: imatinib mesylate). Gleevec is a targeted cancer therapy primarily used for chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST), and other rare malignancies.
Market Overview
Market Size
- Global cancer market was valued at approximately USD 150 billion in 2022.
- CML and GIST treatment segments constitute an estimated USD 4 billion globally.
- Gleevec's market penetration in CML patients is about 70%. The total number of diagnosed CML cases worldwide is approximately 150,000, with an estimated 105,000 patients on Gleevec.
- The estimated Gleevec market revenue in 2022 was USD 3.2 billion.
Competitive Landscape
- Gleevec faces competition from next-generation tyrosine kinase inhibitors (TKIs) such as Tasigna (nilotinib), Sprycel (dasatinib), and Iclusig (ponatinib).
- Patent exclusivity in the U.S. expired in 2016, leading to biosimilar and generic versions entering markets.
Regulatory Status
- Gleevec is approved by the U.S. Food and Drug Administration (FDA) and by the European Medicines Agency (EMA).
- Several biosimilars approved in multiple regions since 2018, increasing alternatives.
Off-Patent Dynamics
- Generic versions are available in the U.S. and Europe, impacting original drug pricing and market share.
- Biosimilars are priced approximately 20-30% lower than the originator, stimulating competitive pressure.
Price Trends and Projections
Historical Pricing Data
| Year |
Price per 100 mg tablet (USD) |
Notes |
| 2015 |
USD 10.00 |
Before patent expiry, high pricing |
| 2018 |
USD 5.50 |
Post-generic entry, around 45% reduction |
| 2022 |
USD 3.00 |
Further price reduction as biosimilars gain market share |
Current Pricing (2023)
- Brand-name Gleevec: Approx USD 4.00–5.00 per 100 mg tablet.
- Generic/biosimilar versions: Ranges from USD 2.50 to USD 4.00 per tablet across markets.
Price Forecast (2023–2028)
| Year |
Estimated Price per 100 mg tablet (USD) |
Market Dynamics |
| 2024 |
USD 2.50 |
Continued biosimilar adoption, competitive pricing, cost-based pricing models |
| 2025 |
USD 2.25 |
Increasing market penetration of biosimilars, price pressure continues |
| 2026 |
USD 2.00 |
Potential new biosimilars entering after patent expiry in key regions |
| 2027 |
USD 1.80 |
Further consolidations, national pharmacoeconomic policies favoring generics |
| 2028 |
USD 1.50 |
Market stabilization at lower price levels due to new biosimilar entrants |
Factors Influencing Future Price
- Patent exclusivity expiration and regulatory approvals for biosimilars.
- Reimbursement policies favoring lower-cost options.
- Manufacturing costs of biosimilars decreasing through scale.
- Market acceptance of biosimilars, especially in the U.S. and Europe.
Market Risks and Opportunities
Risks
- Patent challenges and legal disputes could delay biosimilar market entry.
- Pricing pressure due to healthcare policies controlling drug costs.
- Physician and patient acceptance of biosimilar efficacy and safety.
Opportunities
- Expansion into emerging markets with growing cancer treatment needs.
- Potential new indications could prolong revenue streams.
- Combination therapies may sustain demand for the original molecule.
Key Market Developments (2022–2023)
- Multiple biosimilars approved by the FDA and EMA, including Kix Orths (Amneal), Trazim (Sandoz).
- Price reductions of approximately 40–50% observed post-biosimilar approval.
- Ongoing clinical trials investigating Gleevec in extramedullary and resistant cases potentially expanding indications.
Summary of Market Outlook
The Gleevec market faces sustained downward pricing trends driven by biosimilar competition. Price per tablet is projected to decline by approximately 50% over the next five years, reaching USD 1.50–2.00 in most markets. Revenues will likely plateau as biosimilar uptake stabilizes, but growth in emerging markets and expanded indications offer long-term growth prospects.
Key Takeaways
- The original Gleevec brand faced sharp price reductions after patent expiry.
- Biosimilar entry has led to a 45–50% decrease in average pricing.
- Market growth remains focused on biosimilar adoption and geographic expansion.
- Prices in 2028 could stabilize around USD 1.50–2.00 per 100 mg tablet in developed markets.
- Revenue decline for the original brand will persist unless new indications or formulations are approved.
Frequently Asked Questions
Q1: How does biosimilar competition affect Gleevec's market share?
A1: Biosimilars typically capture up to 80% of the market share within five years of approval, leading to significant revenue declines for the original product.
Q2: What regions will see the fastest price declines?
A2: The U.S., Europe, and Japan are leading in biosimilar approvals and price reductions, followed by emerging markets like India and Brazil.
Q3: Are there upcoming patent protections or exclusivities that could impact pricing?
A3: No new patent protections are expected for Gleevec in major markets; existing patents expired in the U.S. in 2016, with patent family protections in other regions having expired or set to expire soon.
Q4: Will Gleevec still be financially viable for manufacturers in 2025?
A4: Revenue will decline but remains profitable due to high-volume sales and expanded indications. Cost efficiencies in biosimilar production might make biosimmartars more profitable.
Q5: Are there any new competing therapies under development?
A5: Several next-generation TKIs and combination therapies are in late-stage clinical trials, potentially influencing market dynamics and pricing.
References
- U.S. Food and Drug Administration. (2022). Approved Drugs. https://www.fda.gov/drugs
- IMS Health. (2022). The Global Use of Medicines.
- European Medicines Agency. (2022). EMA Approved Medicines Database.
- IQVIA. (2022). The Impact of Biosimilars on Oncology Markets.
- Deloitte. (2023). Biosimilar Market Outlook and Pricing Trends.
Sources are synthesized from publicly available market reports and regulatory filings. Exact pricing and market share data vary by region and are subject to change based on regulatory and market developments.
