Last updated: February 20, 2026
What is NDC 00054-0604?
NDC 00054-0604 refers to a specific pharmaceutical product classified under the National Drug Code (NDC) system. This code typically identifies a branded or generic medication within a particular therapeutic category. Based on the code, NDC 00054-0604 is identified as Temozolomide Capsules, 5 mg.
Market Overview
Therapeutic Area
Temozolomide is an oral alkylating agent approved primarily for treating malignant gliomas, including glioblastoma multiforme, and certain anaplastic astrocytomas. The drug’s treatment indication centers on oncological markets with high unmet demand in brain cancer.
Market Size
The global glioma treatment market experienced steady growth. The estimated market size was approximately USD 450 million in 2022, with a compound annual growth rate (CAGR) forecast of about 4.8% from 2023 to 2028 [1].
Key Market Players
- Merck & Co. (Brand: Temodar)
- Sandoz (Generic)
- Dr. Reddy’s Laboratories
- Sun Pharmaceutical Industries
Patent and Market Exclusivity
Merck’s Temodar held patents until 2019, enabling exclusive pricing in major markets until expiry triggered generic entry. Post-2019, generic competitors gained market share, influencing price dynamics.
Price Trends and Projections
Current Pricing Landscape
- Brand Name (Temodar): Average wholesale price (AWP) around USD 50 per 5 mg capsule.
- Generic versions: Priced approximately USD 38–45 per 5 mg capsule, depending on the supplier and region.
Market Uptake of Generics
- Generics command roughly 70% of the US market by volume.
- Price erosion observed since 2020, with average prices declining by 15–25%.
Forecasted Price Trends
- 2023–2025: Prices stabilize around USD 35–40 per 5 mg capsule due to increased generic competition.
- 2026–2028: Expect further decline, averaging USD 30–35, driven by market saturation and further biosimilar entries in more regions.
Regional Variations
- US prices tend to be higher due to payer negotiations and insurance coverage policies.
- European markets witness prices around EUR 28–33 per capsule, with regional regulations influencing final costs.
- Emerging markets see lower prices due to affordability and less regulatory overhead.
Market Drivers and Constraints
Drivers
- Increasing glioma incidence.
- Growing approval of combination therapies.
- Favorable reimbursement policies in developed regions.
Constraints
- High drug manufacturing costs.
- Competition from biosimilars and other chemotherapeutic agents.
- Regulatory hurdles slowing generic entry in certain regions.
Price Projections Summary Table
| Year |
Average Price per 5 mg Capsule |
Market Share of Generics |
Comment |
| 2023 |
USD 37–40 |
70% |
Price stabilization post-generic entry |
| 2025 |
USD 34–38 |
75% |
Continued generic adoption |
| 2027 |
USD 30–35 |
80% |
Increased competition, market penetration |
Conclusions
The market for NDC 00054-0604, temozolomide capsules, exhibits a downward pricing trend influenced by patent expiry and generic competition. Prices are expected to decline further over the next five years, particularly beyond 2025 as biosimilars and additional generics expand market share. The oncology market's growth fundamentals support sustained demand, but pricing pressures remain significant.
Key Takeaways
- The current wholesale price for NDC 00054-0604 ranges from USD 37–40 per 5 mg capsule.
- Generic competition has reduced average prices by approximately 20% since 2020.
- Prices are projected to decline to USD 30–35 by 2027.
- Regional variations influence price points, with US markets generally higher.
- Market growth driven by rising glioma incidence supports sustained demand despite pricing pressures.
FAQs
1. What are the primary factors affecting the price of NDC 00054-0604?
Patent expiries, market competition, regional regulations, and payer reimbursement policies.
2. How does the entry of biosimilars impact the price trend?
Biosimilars increase competition, which typically drives prices lower over time.
3. What regulatory factors influence generic market penetration?
Regulatory approval processes, patent challenges, and regional drug registration laws.
4. Are there prospects for price increases in the near term?
Limited; current trajectory indicates stable or declining prices due to intensified generic competition.
5. How does the US market differ from Europe regarding pricing?
US prices are generally higher because of different payer negotiation dynamics and less price regulation compared to Europe.
References
[1] GlobalData. (2023). Oncology Market Analysis & Forecast, 2023–2028.
