Last updated: February 21, 2026
What is the Drug NDC 00456-4020?
NDC 00456-4020 refers to a marketed pharmaceutical product, identified by its unique National Drug Code (NDC). This code corresponds to Gleevec (imatinib mesylate), a tyrosine kinase inhibitor approved for treatment of chronic myeloid leukemia (CML), gastrointestinal stromal tumors (GIST), and other cancers. Gleevec was first approved by the FDA in 2001 and has maintained a prominent position in hematology-oncology therapy.
Market Size and Demand Dynamics
Global Market Overview
The global oncology drug market was valued at approximately $180 billion in 2022, with targeted therapies like Gleevec accounting for around $15 billion of this figure.
Key Market Drivers
- Prevalence of CML and GIST: Estimated 8,000 new CML cases annually in the U.S. and an increasing diagnosis rate globally.
- Treatment Duration and Demand: Patients often require long-term therapy, extending product revenue streams.
- Patent Expiry and Market Competition: Gleevec's primary patent expired in 2016 in the U.S., leading to the emergence of generic versions, which significantly affected market share and pricing.
Competition Landscape
| Product |
Type |
Launch Date |
Patent Status |
Price Tier |
| Gleevec (brand) |
Brand |
2001 |
Expired in 2016 (U.S.) |
Premium |
| Imatinib (generic) |
Generic |
2016 |
Patent expired |
Lower (50% less) |
Market Penetration
Generics have captured 70-80% of the U.S. market share since 2016, leading to significant price erosion for the originator brand.
Product Pricing and Cost Analysis
Original Gleevec Pricing
- Brand price (pre-expiry): Approximately $9,000 per month per patient in the U.S.
- Average annual treatment cost: $108,000 per patient.
Generic Imatinib Pricing
- Market price: Approximately $4,500 per month.
- Annual cost per patient: ~$54,000.
Current Wholesale Acquisition Cost (WAC) and Average Wholesale Price (AWP):
| Year |
Brand Gleevec (per unit) |
Generic Imatinib (per unit) |
| 2020 |
$9.00 (per 100 mg tablet) |
$4.50 (per 100 mg tablet) |
| 2022 |
Maintains similar levels |
Maintains similar levels |
Price Projections (Next 3-5 Years)
- Branded Gleevec: Prices likely to decline further due to biosimilar and generic competition, stabilizing around $3,000-$3,500 per month.
- Generics: Expected to remain at or below current levels, possibly dropping to $3,000 per month with increased market penetration.
Regulatory and Policy Impacts
Patent Landscape
- Patent expiration: 2016 in the U.S.
- Patent extensions: Some manufacturers have sought new patents related to formulations to delay generic entry.
- Biosimilar approval: No biosimilars for Gleevec approved yet, but biosimilar competition for related molecules is emerging.
Price Regulation Policies
- U.S.: No direct price controls; market dynamics primarily influence pricing.
- Global markets: Countries like Canada, Germany, and Australia implement price caps and reimbursement thresholds, leading to price compression.
Investment and R&D Outlook
R&D Pipeline
- Several drug candidates target CML and GIST with novel mechanisms or improved efficacy.
- Enhanced formulations (e.g., extended-release versions) are under development to improve adherence.
Market Opportunities
- Combination therapies with Gleevec for resistant cases.
- Strategic entry into underserved markets with generic supplies.
- Development of biosimilars pending regulatory approval.
Key Competitive Strategies
| Strategy |
Description |
| Price reduction |
Lower prices to defend market share |
| Formulation innovation |
Develop extended-release versions |
| Geographic expansion |
Target emerging markets with lower prices |
| Partnership and licensing |
Collaborate with biosimilar producers |
Price Outlook Summary (Next 3-5 Years)
| Scenario |
Branded Gleevec |
Generic Imatinib |
| Conservative (stable) |
$3,000/month |
$3,000/month |
| Aggressive price cuts |
$2,500/month |
$2,500/month |
Key Takeaways
- Patent expiry has shifted market share from Gleevec to generics, causing price reductions.
- Market demand remains stable due to the chronic nature of target cancers.
- Pricing for Gleevec will trend downward, stabilizing around $3,000 monthly for the brand.
- Generics are likely to maintain competitive prices, possibly dropping below $3,000 per month.
- R&D investments target improved formulations and combination therapies for resistant or refractory cases.
FAQs
1. How did patent expiration affect Gleevec pricing?
Patent expiration in 2016 led to the entry of generics, which caused the brand's market share and price to decline sharply.
2. What factors influence future Gleevec prices?
Patent status, regulatory policies, competitive biosimilar development, and market demand drive future pricing.
3. Will Gleevec remain commercially viable?
Yes, due to the chronic treatment nature and ongoing R&D efforts for improved formulations and combination therapies.
4. How does the market for Gleevec compare internationally?
In countries with price regulation, the drug's price is significantly lower than in the U.S., impacting overall revenue and market penetration.
5. Are biosimilars or generics expected to replace Gleevec entirely?
While generics have replaced Gleevec in many markets, biosimilar development may further influence competition and pricing landscape.
References
- U.S. Food & Drug Administration. (2022). Gleevec (imatinib) approval history.
- IQVIA. (2022). Global Oncology Market Report.
- FDA. (2016). Patent and exclusivity data for imatinib.
- Statista. (2022). Oncology drug sales worldwide.
- GlobalData. (2023). Biosimilar landscape analysis.
