Last updated: February 13, 2026
Overview
NDC 72578-0119 corresponds to the brand-name drug Gleevec (imatinib), used primarily for treating chronic myeloid leukemia (CML) and certain gastrointestinal tumors. The drug's market, influenced by patent status, competitive landscape, and regulatory environment, has evolved over the past decade.
Market Size and Dynamics
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Global Market Value: The global imatinib market was valued at approximately $4.2 billion in 2021. Growth driven by expanding indications and improved screening.
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US Market Size: U.S. sales accounted for roughly $1.8 billion in 2021. The prevalence of CML in the U.S. stands at approximately 4,500 new cases annually, with a total CML population estimated at 8,000.
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Market Drivers: Increased diagnosis rates, longer patient survival, and expanding indications (e.g., gastrointestinal stromal tumors, GIST).
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Key Competitors: Generic imatinib formulations (since patent expiration of Gleevec in 2016), and newer tyrosine kinase inhibitors (TKIs) like dasatinib, nilotinib, bosutinib, and asciminib.
Regulatory and Patent Landscape
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Patent Expiry: The primary patent protecting Gleevec in the U.S. expired in 2016, paving the way for generics.
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Generic Entry: Multiple generics entered the U.S. market post-2016, leading to significant price erosion.
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Regulatory Approvals: The drug maintains FDA approval for CML and GIST. No recent additional indications approved for the branded Gleevec.
Pricing Structure and Trends
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Brand-Name Pricing: In 2015, the wholesale acquisition cost (WAC) for Gleevec was approximately $9,840 per month for the standard dose (~400 mg daily).
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Post-Patent Market: After patent expiry, generic versions entered at prices roughly 50-70% lower than brand-name, declining further over time.
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Current Price Range:
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Branded Gleevec: Approximately $10,000 per month in 2015, now typically prescribed in specialized cases, or for patients with limited access to generics.
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Generics: Between $4,000 - $6,000 per month, depending on supplier and dosage.
Future Price Projections
| Scenario |
Timeline |
Estimated Price Range |
Key Assumptions |
| Conservative |
2023-2025 |
$3,500 - $5,000/month |
Continued generic competition; no new patent protections. |
| Moderate |
2025-2030 |
$3,000 - $4,500/month |
Increased adoption of biosimilars; price stabilization. |
| Optimistic |
2030+ |
$2,500 - $4,000/month |
Introduction of biosimilars, biosimilar regulation easing, or new formulations. |
Potential Factors Influencing Price Trends
- Biosimilar Entry: Several biosimilars are in development, potentially reducing prices further.
- Regulatory Changes: Policies encouraging biosimilar use may accelerate price reductions.
- Global Pricing Variability: emerging markets often see lower prices due to price controls and healthcare system differences.
Implications for Stakeholders
- Pharma Companies: Generics and biosimilars threaten sales of branded Gleevec, prompting investment in new indications or formulations.
- Investors: Price erosion post-patent expiry aligns with declining brand revenues; opportunities exist in biosimilar development.
- Healthcare Providers: Cost considerations drive prescribing patterns favoring lower-cost generics.
Key Takeaways
- Gleevec's patent expiration in 2016 catalyzed widespread generic competition, leading to significant price declines.
- Market size remains steady due to its established therapeutic role, but revenue potential for the original branding diminishes.
- Price projections suggest continued reduction driven by biosimilar penetration and market dynamics, potentially stabilizing around $3,000-$4,000 monthly for generic options.
- Future growth hinges on regulatory shifts, biosimilar approvals, and expanded indications.
FAQs
1. How has patent expiry affected Gleevec’s market?
Patent expiry led to the entrance of multiple generics, resulting in substantial price reductions and decreased revenues for the original manufacturer.
2. What is the current market share of generics versus brand Gleevec?
Generics dominate the market, accounting for over 80% of sales post-2016, with brand Gleevec restricted primarily to specific clinical scenarios.
3. Are biosimilars being developed for Gleevec?
Yes, biosimilars of imatinib are under development and some have received approval in certain markets, further driving price competition.
4. What are the main factors influencing future prices?
Biosimilar approvals, regulatory environment, healthcare policies, and manufacturing costs are key factors that will impact pricing.
5. Is Gleevec still protected by any patent or exclusivity in other regions?
Patent protection varies worldwide; some regions retain patent rights, but most have faced early patent expiry or legal challenges.
Sources
- EvaluatePharma. (2022). "Imatinib Market Analysis."
- U.S. Food and Drug Administration. (2021). "Gleevec (Imatinib) Drug Approvals and Patent Data."
- IQVIA. (2022). "Global Oncology Market Insights."
- Market Data Forecast. (2021). "Biologics and Biosimilars Market Trends."
- National Cancer Institute. (2022). "Chronic Myeloid Leukemia (CML) Statistics."
