Last updated: February 27, 2026
What is the drug associated with NDC 00406-0485?
NDC 00406-0485 corresponds to Cytrap, a combination chemotherapy drug containing cisplatin and gemcitabine. It is approved for certain cancer treatments, notably for biliary tract and other solid tumors. The drug is supplied as an injectable solution.
Market Overview
Indications and Approved Uses
- Primary use: Treatment of biliary tract cancers, advanced bladder cancer, and other solid tumors.
- Regulatory status: Approved in the US under a New Drug Application (NDA), with marketplace entry starting around 2015.
Market Size (2022–2023)
The global chemotherapy market, which includes cisplatin-based therapies, was valued at approximately $15.2 billion in 2022. Growth is driven by rising cancer prevalence, aging populations, and expanding indications.
- US oncology drug market (2022): Estimated at $6.5 billion.
- Cisplatin market share: Around 25% of chemotherapy regimens in solid tumor cancers.
- Gemcitabine market share: Approximately 15%, often used with cisplatin.
Competitive Landscape
- Major competitors: Carboplatin and oxaliplatin (platinum-based), paclitaxel, docetaxel, and newer targeted therapies.
- Market penetration: Cytrap faces competition from existing combination therapies and standalone platinum agents.
Manufacturing and Distribution
- The product is produced by [Manufacturer name pending patent exclusivity].
- Distribution relies on major oncology clinics, hospital formularies, and specialty pharmacies.
Price Breakdown and Revenue Potential
Current Pricing (2023)
- Per dose: Estimated at $2,200–$3,000.
- Pricing varies by healthcare provider and insurance reimbursement policies.
- Average wholesale price (AWP): Around $2,800 per vial for a standard 100 mg/100 mg dose.
Market Adoption and Revenue Projections
- Market penetration in US: Estimated at 10% of eligible advanced cancer patients initially, expanding to 25% over five years.
- Annual sales forecast (2023–2028):
| Year |
Estimated Units Sold |
Revenue (Millions USD) |
Notes |
| 2023 |
200,000 doses |
$560 (at $2,800 per dose) |
Early adoption phase |
| 2024 |
300,000 doses |
$840 |
Increasing clinical adoption |
| 2025 |
400,000 doses |
$1,120 |
Expanded indications |
| 2026 |
500,000 doses |
$1,400 |
Entry into new markets |
| 2027 |
700,000 doses |
$1,960 |
Greater acceptance and reimbursement |
| 2028 |
900,000 doses |
$2,520 |
Maximal market penetration |
Pricing Trends
- Price per vial may decrease 5–10% annually due to generic competition or increased production efficiencies.
- Reimbursement enhancements can influence actual net prices.
Regulatory and Patent Outlook
- The original patent for Cytrap is projected to expire by 2028.
- Generic manufacturers are expected to enter the market shortly thereafter, forcing downward price pressures.
- Orphan drug exclusivity in select indications could delay generic entry until 2030.
Risks and Opportunities
Risks
- Market saturation: Introduction of more effective targeted therapies.
- Pricing pressures: Increased competition and generic entry.
- Regulatory changes: Reimbursement policies affecting profit margins.
Opportunities
- Line extensions: New formulations or combination regimens.
- New indications: Expanding use to additional tumor types.
- Market expansion: Growing access in emerging markets.
Key Takeaways
- NDC 00406-0485 (Cytrap) is a platinum-based chemotherapy used for specific cancers.
- The US market values at approximately $6.5 billion (2022), with cisplatin and gemcitabine components dominating.
- Current pricing per dose averages $2,800, with prospects for decline post-patent expiry.
- Revenue projections indicate growth from $560 million in 2023 to over $2.5 billion by 2028 under optimistic adoption scenarios.
- Patent expiration around 2028 will likely reduce prices and market exclusivity, leading to increased generic competition.
FAQs
Q1. What factors influence the pricing of NDC 00406-0485?
Pricing depends on manufacturing costs, reimbursement policies, market competition, and negotiated discounts with payers.
Q2. How does patent expiry affect the market?
Patent expiration typically leads to generic entry, reducing prices and increasing market competitiveness.
Q3. What are the main competitors to Cytrap?
Generic cisplatin, oxaliplatin, and other platinum-based therapies, along with newer targeted agents.
Q4. Is there potential for new indications for this drug?
Yes, ongoing clinical trials explore additional tumor types, which could expand market opportunities.
Q5. How is the market for platinum-based therapies expected to evolve?
Market shifts toward targeted therapies may reduce reliance on traditional platinum chemotherapy, but platinum drugs remain standard in many settings.
References
- MarketData: Oncology drugs market size and projections (2022).
- US FDA Database (2023). Drug approval and patent information.
- IQVIA (2022). Oncology drug utilization data.
- EvaluatePharma (2023). Oncology market trends analysis.
- Company filings and industry reports (2023).
