Last updated: February 25, 2026
What is NDC 58151-0283?
NDC 58151-0283 is a drug product identified by the National Drug Code (NDC). According to the Food and Drug Administration (FDA) and drug pricing databases, this NDC corresponds to Imatinib Mesylate, marketed under the brand Gleevec by Novartis. It is used primarily to treat chronic myeloid leukemia (CML) and gastrointestinal stromal tumors (GIST).
Market Overview
Market Size and Demand Drivers
| Parameter |
Data |
| Approved indications |
CML, GIST, other hematologic conditions |
| Estimated U.S. prescriptions in 2022 |
15,000–20,000 units |
| Reimbursement landscape |
Coverage predominantly through Medicare, Medicaid, private insurers |
| Market share (by value) for Gleevec |
Dominated by Novartis, with generic competition emerging in recent years |
| Patent status |
Patent expired in 2016; multiple authorized generics now available |
Competitive Environment
- Brand Name: Gleevec
- Generics: Multiple approved generics have entered the market since patent expiry.
- Key competitors: Imatinib citrate generics from Sandoz, Teva, and other manufacturers.
- Market share: The brand’s market was approximately 60% of sales pre-patent expiry; generics now hold roughly 50–70% of the volume, depending on regional regulations.
Pricing Dynamics
| Product type |
Average Wholesale Price (AWP) per 100 mg dose (2022) |
| Gleevec (brand) |
$20–$25 |
| Generic Imatinib (equivalent) |
$8–$12 |
Price erosion is driven by generic competition, with prices decreasing approximately 40–60% since patent expiry.
Price Projections
Short-term (1-2 years)
- Brand (Gleevec): Prices remain stable in the absence of patent protection within U.S. markets. List prices are unlikely to increase due to generic competition.
- Generics: Prices fluctuate based on market penetration, manufacturing costs, and reimbursement factors. Expect continued decline, with some stabilization at approximately 50% of brand prices.
Long-term (3-5 years)
- Patent landscape: No further patent protections are anticipated on the original compound.
- Market presence: Generics are projected to maintain 60–80% market share.
- Pricing trend: Further erosion of generic prices may plateau at $4–$8 per 100 mg dosage, driven by manufacturing efficiencies and market competition.
Regulatory and policy impact
- Pricing regulations: Limited in the U.S.; policies favoring biosimilar or generic substitution could influence price stabilization.
- International markets: Pricing varies; developed markets see higher prices due to regulatory and reimbursement differences.
Revenue and Market Valuation Forecast
| Year |
Estimated Sales (USD millions) |
Drivers |
| 2023 |
$150–$250 |
Continued generic uptake, stable demand |
| 2025 |
$100–$180 |
Market consolidation, price erosion |
| 2030 |
$80–$120 |
Patents remain expired, market saturation |
Key Takeaways
- NDC 58151-0283 (imatinib mesylate) markets primarily as Gleevec, with declining prices due to generic competition.
- Short-term prices for Gleevec are stable; generics see a significant decrease.
- Long-term prices for generics are projected to stabilize at 25–40% of original brand prices.
- Market share shifts towards generics could impact revenue, with total sales decreasing over time.
- International markets may present different pricing and reimbursement dynamics, likely maintaining higher prices than the U.S.
FAQs
Q1: Will the price of Gleevec increase again?
A1: Unlikely, as patent expiration and generic entries suppress list prices. Price increases would primarily stem from supply disruptions or regulatory changes.
Q2: How do biosimilars impact the market?
A2: Biosimilars are not typically applicable for small-molecule drugs like imatinib. They primarily impact biologics.
Q3: What is the best forecast model for generic prices?
A3: An S-curve model reflecting initial rapid decline post-generic entry, followed by stabilization, applies. Prices are expected to plateau around 50% of the original brand price within 3-5 years.
Q4: How do international policies affect pricing?
A4: Developed countries maintain higher prices due to regulation and reimbursement frameworks. Emerging markets may see lower prices driven by local manufacturing and policies.
Q5: Are there any new formulations or indications that could change the market?
A5: No significant new formulations or indications are currently approved, limiting market evolution in the near term.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] IQVIA. (2022). National Prescription Audit Data.
[3] FDA. (2016). Patent status for Gleevec.
[4] SSR Health. (2022). Retail Prescription Market Analysis.
[5] Evaluate Pharma. (2022). Global Oncology Market Trends.
