Last updated: February 21, 2026
What is NDC 49348-0521?
NDC 49348-0521 refers to a specific drug product listed in the National Drug Code (NDC) database. This code corresponds to Temozolomide Capsules, 20 mg, marketed mainly for the treatment of gliomas, including glioblastoma multiforme and anaplastic astrocytoma (per FDA and manufacturer data).
Market Size and Demand
Global Market Overview
The global brain cancer treatment market, which includes drugs like Temozolomide, was valued at approximately $700 million in 2022. This figure is projected to reach $1.2 billion by 2030, with a compound annual growth rate (CAGR) of around 6.1% (per Grand View Research). Growth drivers include increasing incidence of gliomas and advancements in targeted therapies.
U.S. Market Dynamics
In the United States, the annual sales of Temozolomide were approximately $500 million in 2022. This market is chiefly driven by Medicare and private insurers covering standard-of-care regimens. The drug is a first-line chemotherapeutic agent for glioblastoma, making it a high-demand product.
The patient population in the U.S. is estimated at 10,000-12,000 new cases of glioblastoma annually, with prior treatments and off-label uses expanding the overall prescription volume.
Competitive Landscape
Major competitors include:
- Generic versions of Temozolomide: Available from multiple manufacturers, such as Teva, Mylan, and Sun Pharma.
- Branded variation: The original formulation by Merck, marketed as Temodal.
Competition primarily affects pricing strategies, with generics commanding significantly lower prices.
Pricing Analysis
Historical Pricing Data
| Price Component |
2020 |
2022 |
Notes |
| Brand Name (Temodal) |
~$1,200 per 100-count bottle |
~$1,350 per 100-count bottle |
Above-average retail price, influenced by brand positioning. |
| Generic Versions |
~$600-$800 per 100-count |
~$800-$1,000 per 100-count |
Price varies by manufacturer, with increased competition pressuring margins. |
| Cost per capsule |
~$12-$13 |
~$14-$15 |
Based on bottle size, typically 20 mg capsules. |
Price Projections (2023-2027)
| Year |
Estimated Average Price per 100 Capsules |
Key Factors |
| 2023 |
$950 - $1,050 |
Generic competition intensifies, supply chain stabilizes. |
| 2024 |
$900 - $1,000 |
Market saturation with generics, potential biosimilar entries. |
| 2025 |
$850 - $950 |
Patent expiry for original formulations, cost pressures persist. |
| 2026 |
$800 - $900 |
Price decline stabilizes; incremental innovations may sustain values. |
| 2027 |
$750 - $850 |
Further generic proliferation, global price adjustments. |
External Influences on Pricing
- Patent expirations: Original patent protections expired in 2015, opening markets for generics.
- Regulatory changes: Potential biosimilar or interchangeable designations may influence prices.
- Reimbursement policies: CMS and private insurers increasingly negotiate prices, impacting net revenue.
- Manufacturing costs: Slight increases in raw materials and manufacturing could temper price decreases.
Regulatory and Economic Trend Impact
- The entrance of biosimilars and chemically equivalent generics tends to put downward pressure on branded product pricing.
- Pricing dynamics are sensitive to healthcare policy reforms aimed at drug price reductions.
- High R&D costs for biosimilars may slow innovation-driven price increases.
Price Forecast Summary
| Year |
Estimated Retail Price Range |
Notes |
| 2023 |
$950 - $1,050 |
Continued generic competition impacts brand pricing. |
| 2024 |
$900 - $1,000 |
Cost-based pricing pressures persist. |
| 2025 |
$850 - $950 |
Market stabilization; biosimilar presence grows. |
| 2026 |
$800 - $900 |
Further price reductions expected. |
| 2027 |
$750 - $850 |
Generic market dominance sustains lower prices. |
Key Takeaways
- The global and U.S. markets for Temozolomide are growing modestly, driven by gliomas' rising incidence.
- Patent expiration and proliferation of generics have significantly driven down prices.
- Future pricing will be influenced by competition, regulatory changes, and reimbursement policies.
- Price stabilization is expected around $750-$850 per 100 capsules by 2027, with potential for further declines if biosimilars or new treatments enter the market.
FAQs
-
What factors influence Temozolomide pricing post-patent expiry?
Generic competition, manufacturing costs, and reimbursement negotiations significantly impact pricing.
-
How does the emergence of biosimilars affect Temozolomide prices?
Biosimilars can lead to further price reductions due to increased competition.
-
What is the typical cost of a complete treatment course?
A standard regimen may require about 6 cycles of 140 capsules each, totaling approximately $8,400 to $10,500 at current prices.
-
Are there expected regulatory changes that could influence future pricing?
Changes allowing for biosimilar or interchangeability designations could affect market dynamics and prices.
-
How does the market outlook for Temozolomide compare to other chemotherapeutic agents?
It follows similar trends—exponential growth post-patent expiration, driven by generic entry and pricing pressures.
Citations
[1] Grand View Research. (2023). Brain Cancer Treatment Market Size, Share & Trends Analysis Report.
[2] FDA. (2015). Temozolomide Approval and Prescribing Information.
[3] IQVIA. (2022). Pharmaceutical Pricing Trends.
[4] Merck & Co. (2022). Temodal Official Site and Product Literature.
[5] Centers for Medicare & Medicaid Services. (2022). Reimbursement and Policy Guidelines.
