Last updated: March 11, 2026
What is NDC 70700-0312?
National Drug Code (NDC) 70700-0312 corresponds to Imatinib mesylate, marketed as Gleevec/Glivec. It is a targeted therapy for certain cancers, primarily chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
Market Overview
Market Size and Demand
- Prevalence: CML affects roughly 5,000-6,000 new patients annually in the U.S., with global numbers estimated at 50,000-80,000.
- Sales Volume: Approximately 2.5 million prescriptions dispensed in the U.S. in 2022, reflecting consistent demand due to its status as a first-line therapy.
Competitive Landscape
- Main competitors: Dasatinib (Sprycel), nilotinib (Tasigna), bosutinib (Bosulif), and generic imatinib.
- Patent status: The original patent expired in 2016; multiple generics entered the market in 2017, increasing competition and reducing prices.
Regulatory and Reimbursement Context
- FDA approval since 2001.
- Pricing: The originator's list price was about $147,000 annually in 2017; generics now represent approximately 20-30% of original list prices.
- Insurance: High coverage, with coverage rates above 90%, sustaining consistent demand.
Historical Price Trends
| Year |
Brand Price (per month) |
Generic Price (per month) |
Percentage Price Drop (Year-over-Year) |
| 2016 |
$12,250 |
— |
— |
| 2017 |
$10,000 |
$4,200 |
15-30% (generic) |
| 2018 |
$9,500 |
$3,500 |
15-20% |
| 2019 |
$9,200 |
$2,800 |
5-10% |
| 2020 |
$9,000 |
$2,400 |
stable to declining |
Pricing Dynamics and Projections
Current Market Pricing
- Brand (Gleevec/Glivec): Approximate retail list price is $9,000–$10,000 per month.
- Generics: Range between $2,400–$3,500 per month, with some variations based on manufacturer and contract negotiations.
Market Drivers for Price Trends
- Generic penetration: Continued growth reduces brand pricing power.
- Pricing strategies: Manufacturers may employ price stabilization tactics in emerging markets.
- Patent litigation and exclusivity periods: No active patent protection from 2016.
Future Price Projections (Next 5 Years)
| Year |
Estimated Brand Price (per month) |
Estimated Generic Price (per month) |
| 2023 |
$8,500–$9,500 |
$2,000–$3,300 |
| 2024 |
$8,000–$9,000 |
$1,800–$3,000 |
| 2025 |
$7,500–$8,500 |
$1,600–$2,800 |
| 2026 |
$7,000–$8,000 |
$1,400–$2,500 |
| 2027 |
$6,500–$7,500 |
$1,200–$2,200 |
Projection assumptions include:
- Continued generic market share growth.
- No significant patent litigation blocking generic entry.
- Modest inflation-adjusted price reductions based on current trends.
- Stable demand due to the disease's prevalence and clinical guidelines.
Key Influencing Factors
- Patent expiry: Clear since 2016.
- Price elasticity: High for generics; brand prices decline faster as competition increases.
- New formulations or indications: Potential for minor premium adjustments but unlikely to alter overall price landscape.
Market Entry and Impact Analysis
- Entry of biosimilars or next-generation therapies could further reduce prices.
- Price decline curve suggests face value erosion towards $2,000–$3,000 for generics within five years.
- Manufacturers may introduce value-added services or combination therapies to sustain prices.
Summary
Imatinib (NDC 70700-0312) faces a declining price trajectory driven by patent expiration, generic competition, and market saturation. Current generic prices hover around 20-25% of original brand pricing. Price projections indicate a continued downward trend, with median generic prices falling below $2,500 per month by 2027. The brand retains some premium pricing due to brand loyalty and safety profile, but sustained at a lower level.
Key Takeaways
- Generic competition has significantly reduced imatinib's market price since 2017.
- Prices for generics are expected to decline further over the next five years.
- Demand remains stable due to the drug's critical role in cancer therapy.
- Future pricing will be sensitive to patent litigation, new therapy development, and healthcare policy changes.
- Investment in generic manufacturing or bios touchpoints may be profitable given expected price reductions.
FAQs
Q1. How has patent expiry affected imatinib prices?
Patent expiry in 2016 triggered generic entry, reducing prices by approximately 70% within two years.
Q2. What are the main factors influencing future prices?
Generic market penetration, regulatory environment, new competitors, and policy reforms.
Q3. How does the demand forecast for imatinib look?
Demand remains steady due to its essential role in treating specific cancers; no foreseeable decline.
Q4. Are biosimilars impacting imatinib's market?
Potentially. Biosimilars could influence pricing, but their entry depends on regulatory approvals and market acceptance.
Q5. What's the risk of price stabilization or increase?
Limited, unless new formulations or indications emerge, or market disruptions occur.
References
- U.S. Food and Drug Administration. (2022). Imatinib mesylate drug approval history. [FDA Database].
- IQVIA. (2022). Prescription Drug Market Data.
- Taylor, P., & Ashton, C. (2021). Patent expiration and biosimilar entry in oncology drugs. Journal of Pharmacoeconomics & Outcomes Research, 11(3), 245-254.
- EvaluatePharma. (2022). Market forecast for cancer therapeutics.
- Statista. (2023). Cancer prevalence and drug sales in the U.S.
