Last updated: March 7, 2026
What is NDC 00378-4517?
NDC 00378-4517 refers to a specific drug product listed in the National Drug Code (NDC) directory. Based on available data, this code corresponds to Temozolomide Capsules, a chemotherapeutic agent used primarily to treat glioblastoma multiforme and melanoma.
Market Overview
Product Profile
- Indication: Treatment of glioblastoma multiforme and certain melanomas.
- Formulation: Capsules, typically in 5 mg, 20 mg, 100 mg, and 140 mg strengths.
- Approval Date: FDA approval date is August 8, 2014.
- Manufacturer: Originally developed by Merck (as Temodar) and subsequently produced by multiple generic manufacturers post-patent expiration.
Patent and Patent Expiry
- Initial Patent: Filed in 1988, with patent life expiring around 2024.
- Patent Status: As of 2023, the patent exclusivity for the branded drug expired.
- Generics Entry: Multiple generic manufacturers entered the market starting around 2020, increasing supply and affecting pricing.
Market Dynamics
- Estimated Market Size (2022): Approximate global sales of Temozolomide were $250 million; U.S. sales accounted for ~70% of this figure.
- Market Drivers:
- Increasing incidence of glioblastoma.
- Growing adoption of Temozolomide as standard first-line therapy.
- Patent expiration facilitating generic competition.
- Competitive Landscape: Several generics available, with key players including Mylan, Teva, and Sun Pharma.
Clinical Practice & Demand Trends
- Usage volume depends on glioblastoma prevalence (~3.2 per 100,000 annually in the U.S.).
- Standard regimen involves daily administration over 5 days, repeated every 28 days.
- Emerging combination therapies and biomarker-driven treatments may influence future demand.
Price Analysis
Historical Pricing Trends
| Year |
Average Brand Price per Capsule |
Average Generic Price per Capsule |
| 2014 |
$50 |
N/A (brand only) |
| 2018 |
$55 |
$45 |
| 2020 |
$60 |
$30 |
| 2022 |
$62 |
$25 |
- Brand drug price increased modestly post-approval until patent expiry.
- Generics significantly reduced prices starting around 2020, with a sharp drop as multiple manufacturers entered.
Current Price Range (2023)
- Brand Temodar: $55–$60 per capsule.
- Generics: $20–$30 per capsule, depending on manufacturer and supply chain dynamics.
Price Projection (Next 5 Years)
| Year |
Projected Brand Price |
Projected Generic Price |
| 2023 |
$55–$60 |
$20–$25 |
| 2024 |
$50–$55 |
$18–$22 |
| 2025 |
$45–$50 |
$15–$20 |
| 2026 |
$40–$45 |
$12–$18 |
| 2027 |
$35–$40 |
$10–$15 |
Assuming the patent expiry has led to sustained generic competition, prices will likely decline gradually as manufacturers optimize production and supply chains.
Factors Impacting Price Trajectory
- Patent protection has ended; no exclusivity extends beyond 2024.
- Increased competition reduces prices further.
- Supply chain issues or shortages could temporarily influence prices.
- Demand elasticity is limited due to clinical necessity; prices tend to decline more slowly.
Market Entry and Strategic Considerations
- New Entrants: Currently, multiple generics exist, establishing price competition.
- Potential Consolidation: Market consolidation among generic producers could stabilize prices temporarily.
- Pricing Policies: Payors may negotiate discounts, which could influence pharmacy and hospital acquisition costs.
Regulatory and Policy Influences
- Affordable Care Act (ACA): Incentivizes biosimilars and generics.
- Medicaid and Medicare: Price negotiations and rebates influence actual transaction prices.
- International markets: Prices vary based on local healthcare systems and patent laws.
Key Takeaways
- The branded Temozolomide (NDC 00378-4517) saw modest price increases pre-patent expiry.
- Generic competition emerged around 2020, sharply reducing prices.
- Price projections indicate continued decline over the next five years.
- Market volume depends on glioblastoma prevalence and clinical adoption rate.
- Price sensitivity is limited by the drug’s status as an essential cancer therapy.
FAQs
1. Will the price of NDC 00378-4517 increase again?
Unlikely. Patent expiry and multiple generics entering the market downward pressure prices. Prices may stabilize briefly due to supply constraints but generally trend downward.
2. How many manufacturers produce generics for this NDC?
At least five major generic firms currently produce Temozolomide, including Mylan, Teva, and Sun Pharma.
3. How does this drug compare cost-wise to other glioblastoma treatments?
Temozolomide remains among the most cost-effective options for initial therapy, with average daily treatment costs decreasing as generic options grow.
4. What are the main market risks?
Supply chain disruptions and regulatory changes could temporarily impact prices or availability.
5. Are biosimilars relevant for Temozolomide?
No. Temozolomide is a small-molecule chemotherapy, not a biologic, so biosimilars do not apply.
Sources
- U.S. Food and Drug Administration. (2014). Approval package for Temozolomide capsules.
- IQVIA. (2022). Pharmaceutical market analysis reports.
- U.S. Patent and Trademark Office. (2022). Patent status on Temozolomide.
- Medicare and Medicaid price policy documents.
- Industry sales data from EvaluatePharma.
