Last updated: February 14, 2026
What is the Drug and Its Market Position?
NDC 00173-0633 corresponds to Temozolomide Capsules, marketed primarily under the brand name Temodal. It is an oral chemotherapy drug used to treat glioblastoma multiforme (GBM) and certain malignant melanomas. Approved by the FDA in 1999, it has established a significant presence in oncology.
Temozolomide is a standard of care for GBM, often prescribed following surgical resection and radiation therapy. Its market is characterized by high clinical demand, especially for adult patients with aggressive brain tumors.
How Large Is the Market for Temozolomide?
Market Size
- Global oncology drug market was valued at approximately $180 billion in 2022, with oral chemotherapies representing a growing segment.
- The targeted patient population for Temodar (brand of Temozolomide) exceeds 10,000 annually in the U.S. alone for newly diagnosed GBM and recurrent cases, with global estimates in the range of 25,000–30,000.
Competitive Landscape
- Major competitors include Temodal (original Branded), generic Temozolomide products, and emergent biosimilar offerings.
- Patent expiry for key formulations occurred around 2015, leading to increased generic availability.
- Patent protections on branded formulations have since expired, enhancing generic market share.
Market Drivers
- Growing prevalence of GBM and melanoma.
- Off-label uses in other cancers, such as oligodendroglioma.
- Adoption of combination therapies, increasing usage volume.
What Are Price Trends and Projections?
Current Pricing
- Brand-name Temodal: Approximate list price in the U.S. is around $6,000–$8,000 per 5-week cycle, depending on dosage and pharmacy discounts.
- Generic Temozolomide: Prices range from $1,200 to $2,500 per cycle, reflecting significant reduction due to market entry of generics.
Historical Pricing Trends
- Post-patent expiration (circa 2015), prices of generics decreased by 50–70% over two years, stabilizing at lower levels.
- Brand prices have maintained a premium, generally 3–4 times higher than generics.
Price Projections Over Next 5 Years
| Year |
Brand Price per Cycle |
Generic Price per Cycle |
Comments |
| 2023 |
$6,500 |
$1,800 |
Stability post-patent expiry, slight discounts possible. |
| 2024 |
$6,300 |
$1,500 |
Price maintenance due to limited competition among generics. |
| 2025 |
$6,000 |
$1,200 |
Potential further downward pressure with increased biosimilar competition. |
| 2026 |
$5,800 |
$1,100 |
Entry of new generics could compress prices further. |
| 2027 |
$5,600 |
$1,000 |
Market saturation may limit price increases. |
Factors Affecting Future Pricing
- Patent litigation and exclusivity disputes can temporarily stabilize brand pricing.
- Emergence of biosimilars or additional generics could drastically lower prices.
- Healthcare policies, such as price caps or negotiations, could influence both list and actual transaction prices.
How Will Market Dynamics Affect Future Revenues?
- Price erosion due to biosimilars and generics will continue, compressing profit margins for branded providers.
- Market volume remains relatively stable due to steady incidence rates of GBM and melanoma.
- Expansion into new indications or combination therapies could offset volume declines to some extent.
Key Considerations for Stakeholders
- Pharmaceutical companies should monitor patent status and potential biosimilar entries to time market entry or continued exclusivity strategies.
- Investors should assess generic penetration rates and reimbursement trends impacting price stability.
- Healthcare payers are increasingly negotiating discounts, influencing net pricing and access.
Summary
Temozolomide (NDC 00173-0633) enjoys a stable but gradually declining price outlook driven primarily by generic competition. Current retail prices are approximately 75% lower than when the drug first entered the market but are expected to decrease modestly over the next five years. Volume remains consistent due to ongoing use in GBM and melanoma, but future revenue growth hinges on market share retention, emerging biosimilar competition, and healthcare policy trends.
Key Takeaways
- The global market for Temozolomide is driven by its role in treating GBM, with an estimated 10,000–30,000 cases annually.
- The emergence of generic versions has resulted in significant price reductions since 2015.
- Price projections indicate a slow decline, with generic prices potentially stabilizing near $1,000 per cycle, depending on market competition.
- Revenue stability depends on maintaining market share amid increasing biosimilar competition.
- Regulatory actions and healthcare policies could influence future pricing strategies.
FAQs
1. What are the main generic competitors for Temozolomide?
Multiple manufacturers produce generic Temozolomide, including Teva, Mylan, and Sun Pharma, contributing to price declines and increased market penetration.
2. How does patent expiration affect drug pricing?
Patent expiration allows generic manufacturers to enter the market, significantly reducing prices and intensifying competition.
3. Are there emerging formulations or delivery methods for Temozolomide?
Current focus remains on oral capsules; no substantial alternative formulations have gained FDA approval recently.
4. What are the reimbursement trends for Temozolomide?
Reimbursement generally aligns with negotiated drug prices; private insurers and Medicaid often secure substantial discounts on generics.
5. Will biosimilars impact Temozolomide's pricing?
While biosimilars are less common for small molecules like Temozolomide, regulatory changes and new entrants could further lower prices in future years.
Citations
[1] MarketWatch, "Global Oncology Drugs Market," 2022.
[2] FDA Drugs Database, "Temozolomide (Temodal)," 2023.
[3] GoodRx, "Temozolomide Pricing Data," 2023.
[4] IQVIA, "Prescription Trends and Generic Entry," 2022.
