Last updated: February 24, 2026
What is the Therapeutic Use and Market Position of NDC 52536-0106?
NDC 52536-0106 is identified as Temozolomide Capsules. It is primarily used in the treatment of high-grade gliomas, including glioblastoma multiforme, and certain anaplastic astrocytomas. As an oral chemotherapy agent, it is a standard component of brain cancer treatment protocols.
The drug belongs to a competitive market segment with several FDA-approved formulations, including generics and branded options such as Temodar (Merck), the original branded product. The formulation offers advantages due to oral administration, which impacts its market uptake and pricing strategy.
Market Size and Trends
Global and U.S. Market
The global brain cancer therapeutics market was valued at approximately USD 500 million in 2022, with a compound annual growth rate (CAGR) of around 7% projected through 2030, driven by increased diagnosis rates and ongoing research.
In the U.S., the market for glioma treatments, including temozolomide, was estimated at USD 200 million in 2022. The U.S. accounts for about 40% of the global market.
Key Competitors and Patent Landscape
- Brand: Temodar (Merck) – patent expiry in 2016, leading to widespread generics.
- Generics: Numerous manufacturers producing temozolomide capsules, driving downward pressure on prices.
- Patent Status: No active patents on the capsule formulation since 2016, with competition mainly from generic manufacturers.
Prescriptions and Usage Data
- Approximate annual prescriptions in the U.S.: 60,000 to 80,000 units, reflecting prevalent use in glioma management.
- Reimbursement landscape favors generic options, which dominate market share.
Pricing Overview
Brand vs. Generic Pricing
| Product Type |
Typical Price per Capsule |
Source Year |
| Brand (Temodar) |
USD 60-80 |
2022 |
| Generic (Temozolomide) |
USD 10-20 |
2022 |
Brand-name Temodar remains priced at a premium; generics have driven prices down significantly since patent expiration.
Price Influencers
- Market Competition: High competition among generics limits price increases.
- Reimbursement Policies: Insurance coverage favors lower-cost generics.
- Manufacturing Costs: Variations among manufacturers have limited drastic price fluctuations.
Estimated Future Price Trajectory
| Year |
Estimated Price per Capsule |
Assumptions |
| 2023 |
USD 8-12 |
Market saturation, existing patent expiry effects |
| 2025 |
USD 8-10 |
Ongoing generic competition, stable pricing trends |
| 2030 |
USD 7-9 |
Potential introduction of biosimilars or new formulations |
Prices are expected to stabilize or slightly decline due to persistent generic competition.
Regulatory and Market Dynamics Impact
- The absence of active patent protection constrains pricing power.
- Adoption of biosimilars is unlikely due to the small molecule nature of temozolomide.
- Reimbursement policies heavily influence net pricing and access.
Strategic Considerations for Market Entry
- Entry timing after patent expiry capitalizes on the existing demand.
- Competitive pricing is essential due to the high number of generic manufacturers.
- Focused marketing toward neuro-oncologists and hospital formularies enhances uptake.
- Innovations such as alternative formulations (e.g., extended-release) could command premium pricing if approved.
Key Takeaways
- NDC 52536-0106 is a generic temozolomide capsule for glioma treatment.
- The market size is USD 200 million in the U.S.; global estimates reach USD 500 million.
- Prices currently range USD 8-12 per capsule, trending downward due to competition.
- No active patents limit pricing power; market dynamics favor lower-cost generics.
- Investment opportunities may depend on formulation innovations or regional reimbursement shifts.
FAQs
1. What factors influence temozolomide capsule prices?
Market competition, generic availability, reimbursement policies, and manufacturing costs.
2. How does patent expiry affect the pricing of NDC 52536-0106?
Patent expiry in 2016 led to increased generic competition, reducing prices.
3. What is the future market outlook for this drug?
The market will likely remain stable with slight price declines, driven by generic competition and steady demand for brain cancer treatments.
4. Are there any newer formulations or delivery methods expected?
Novel delivery systems are limited; most innovation focuses on generic manufacturing improvements rather than new formulations.
5. How significant is biosimilar competition for this drug?
Less significant, as temozolomide is a small molecule; biosimilars are not applicable.
References
[1] MarketsandMarkets. (2022). Brain Cancer Therapeutics Market.
[2] IQVIA. (2022). U.S. Oncology Prescriptions Data.
[3] U.S. Food and Drug Administration. (2016). Patent Status of Temozolomide.
