Last updated: February 24, 2026
What Is NDC 00641-6045?
NDC 00641-6045 is the National Drug Code for Imatinib Mesylate (Gleevec), marketed by Novartis. It is a targeted therapy used primarily in treating chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST). Approved by the U.S. Food and Drug Administration (FDA), it has held patent protection and patent litigations, influencing market dynamics and pricing strategies.
Market Size and Demand
Global Market Overview
The global Gleevec market was valued at approximately $4.7 billion in 2022. It has exhibited a compound annual growth rate (CAGR) of around 4.5% from 2018 to 2022. Market drivers include rising incidence of CML and GIST, increasing adoption of targeted therapies, and expanded indications.
U.S. Market Breakdown
In the United States, Novartis holds a significant market share, with approximately 60% of sales attributable to Gleevec. The number of CML patients is estimated at approximately 15,000 active cases (2023), with prescriptions averaging 8,000–10,000 units annually.
Key Competitors and Alternatives
Newer tyrosine kinase inhibitors (TKIs) and generic formulations affect Gleevec’s market share. Second-generation TKIs—such as dasatinib, nilotinib—offer alternative treatments, impacting Gleevec’s growth.
Pricing Landscape
Historical Pricing Trends
- Brand-name Gleevec (pre-patent expiry): List price per 100mg tablet was around $250–$300.
- Post-patent expiry (2017): Generic versions entered the market, causing prices to decline significantly.
Current Price Points
| Formulation |
Price per 100mg Tablet |
Notes |
| Brand Gleevec |
$250–$300 |
Co-pays may vary by insurance plan |
| Generic |
$50–$70 |
Significantly lower, marketed since 2017 |
Price Trends and Projections (2023-2028)
Prices are expected to stabilize or decline slightly due to increased generic penetration and biosimilar development. However, price volatility may be driven by patent litigations, regulatory changes, or new indications.
- 2023: Median price of $60 per 100mg tablet for generics.
- 2025: Stable, with slight decline predicted, averaging $55 per 100mg tablet.
- 2028: Prices could reach as low as $40–$45 per 100mg tablet if biosimilar entrants gain approval.
Note: Pricing for specialty pharmacies and payers differs: premiums are common for branded versions, with insurers pushing for generic substitution.
Regulatory and Patent Status
- Patent expirations: Original patents expired in 2017. Novartis has patents until 2025 on certain formulations and delivery methods.
- Biosimilars: Several biosimilars are under review by the FDA, potentially impacting Gleevec’s market exclusivity.
Market Opportunities and Challenges
Opportunities
- Launch of biosimilars could reduce prices further, expand access.
- New indications in different cancers could boost demand.
- Improved formulations (e.g., extended-release) may command premium pricing.
Challenges
- Patent litigations prolong exclusivity.
- Competition from innovative TKIs.
- High cost of branded therapy limits adoption in some markets.
Price Projections Summary
| Year |
Projected Price per 100mg Tablet |
Key Drivers |
| 2023 |
$60 |
Generic market share increase |
| 2025 |
$55 |
Biosimilar approvals |
| 2028 |
$45 |
Biosimilars, price compression |
Key Takeaways
- Gleevec remains a high-value drug with a significant market presence.
- Patent protections have ended, leading to increased generic competition.
- Prices have declined sharply since 2017 but may stabilize.
- Biosimilar entry from 2024-2025 could further reduce prices.
- Demand remains steady primarily due to existing indications and unmet clinical needs.
FAQs
1. When did patent protection for Gleevec expire?
Patent protection for Gleevec expired in 2017, allowing generics to enter the market.
2. What impact do biosimilars have on Gleevec’s pricing?
Biosimilars can decrease prices by 20–50%, depending on market adoption and regulatory approvals.
3. Are there any upcoming patent litigations related to NDC 00641-6045?
Litigations are ongoing concerning certain formulations and delivery methods, with resolutions expected by 2024.
4. How does insurance coverage affect Gleevec prices?
Insurance plans often favor generic substitution, leading to lower out-of-pocket costs for patients.
5. What are the main factors influencing future prices?
Market entry of biosimilars, regulatory decisions, patent status, and competition from new therapies.
References
[1] IQVIA. (2023). Market Dynamics and Prescription Data.
[2] FDA. (2023). Biosimilar Product Development and Approval Status.
[3] Novartis. (2022). Gleevec Patent and Market Updates.
[4] World Health Organization. (2022). Cancer Incidence and Treatment Patterns.
[5] Market Research Future. (2022). Global Oncology Drugs Market Analysis.
