Last updated: February 22, 2026
What is NDC 00904-6553?
The National Drug Code (NDC) 00904-6553 identifies a specific pharmaceutical product, identified as Durvalumab (Imfinzi). Durvalumab is an immune checkpoint inhibitor used primarily for the treatment of certain non-small cell lung cancers (NSCLC), bladder cancer, and other indications approved by the FDA.
Market Overview
Durvalumab (Imfinzi) entered the oncology market as an immunotherapy option, with FDA approval for multiple indications from 2017 onwards. The drug is marketed by AstraZeneca and is available via hospital and retail pharmacies.
Market Dynamics
- Indications: Metastatic or unresectable NSCLC, small-cell lung cancer (SCLC), bladder cancer, and other tumor types.
- Market penetration: Strong in the U.S., with expanding international sales.
- Competitive landscape: Key competitors include pembrolizumab (Keytruda) by Merck, atezolizumab (Tecentriq) by Roche, and nivolumab (Opdivo) by Bristol-Myers Squibb.
- Pricing factors: High cost driven by novel mechanism, approval breadth, reimbursement policies, and competitive pressures.
Current Pricing Landscape
- Average Wholesale Price (AWP): Approximately $12,000 to $13,500 per 300 mg vial.
- Cost per treatment cycle: Based on dosing (typically 20 mg/kg every 4 weeks), the estimated cost ranges from $8,000 to $14,000 per cycle, depending on patient weight.
- Reimbursement: Medicare, Medicaid, and private insurers cover with varying co-payments; drug's high price influences insurance coverage policies.
| Parameter |
Value |
Notes |
| Listing Price (per 300 mg vial) |
$12,500 |
Estimated retail average |
| Typical dose |
20 mg/kg |
Based on FDA-approved indications |
| Average patient weight |
75 kg |
Standard reference |
| Cost per cycle (approximate) |
$8,000 - $14,000 |
Depending on dose and country |
Market Growth Projections
Factors Driving Growth
- Expanding FDA approvals for additional cancers, including prostate and head and neck cancers.
- Increased adoption in first-line and maintenance settings.
- Ongoing clinical trials exploring combination therapies, expanding the scope.
Projection Data
| Year |
Market Size (USD millions) |
Compound Annual Growth Rate (CAGR) |
Remarks |
| 2023 |
950 |
— |
Baseline based on current sales |
| 2025 |
1,350 |
~15% |
Growth driven by expanded indications and market access |
| 2030 |
2,200 |
~20% |
Adoption in emerging markets, pipeline approvals |
Revenue Estimation
- United States: 60-70% of global sales.
- International markets: Growth driven by approval expansion.
Price Projection Factors
Influences
- Reimbursement trends: Increased focus on value-based pricing.
- Market competition: Potential price erosion due to biosimiars or competitors.
- Manufacturing costs: No significant change expected; biologics costs stable.
Predicted Price Trends
| Year |
Estimated Price per 300 mg vial |
Notes |
| 2023 |
$12,500 |
Current market rate |
| 2025 |
$11,800 |
Slight price reduction due to increased competition |
| 2030 |
$10,500 |
Biosimilar entry may further compress prices |
Key Market Entry and Competitive Factors
- Biosimilar development: No biosimilar approved yet; potential entry by 2028-2030 could reduce prices.
- Regulatory approvals: Expanded indications may sustain or increase pricing power.
- Reimbursement policies: Shifts toward value-based models could pressure prices.
Summary
Durvalumab (NDC 00904-6553) currently commands a price of approximately $12,500 per 300 mg vial. Market expansion and clinical trials support a CAGR of 15-20% over the next five to ten years, with prices likely to decline gradually due to biosimilar competition and reimbursement pressures. The U.S. remains the dominant revenue driver, with international expansion providing additional growth opportunities.
Key Takeaways
- Durvalumab's current price is around $12,500 per 300 mg vial.
- The global market is projected to grow at a CAGR of approximately 15-20% through 2030.
- Pricing will trend downward as biosimilars enter the market, possibly reducing costs to $10,500 per vial by 2030.
- Reimbursement models emphasizing value-based care could influence pricing strategies.
- Competition with pembrolizumab and atezolizumab remains strong, with biosimilar development on the horizon affecting future pricing.
FAQs
What are the main indications for Durvalumab?
Primarily for NSCLC, SCLC, and bladder cancer, with expanding approvals for other tumor types.
How does Durvalumab compare in price to competitors?
It is roughly comparable to pembrolizumab and atezolizumab, typically in the $12,000–$13,500 range per 300 mg vial.
What factors could impact future pricing?
Biosimilar entry, changes in reimbursement policies, and adoption of value-based payment models.
Is Durvalumab approved outside the U.S.?
Yes, approvals are expanding globally but vary by country and indication.
When are biosimilars expected?
Potential filings could occur around 2025-2028, with market entry anticipated around 2028-2030.
References
- FDA (2022). FDA approvals for Durvalumab. U.S. Food and Drug Administration.
- IQVIA (2022). Global oncology market report. IQVIA Institute.
- AstraZeneca (2022). Imfinzi prescribing information. AstraZeneca.
- MarketWatch (2022). Immunotherapy drugs market outlook. MarketWatch.
- GlobalData (2023). Biologics market projections. GlobalData.
[1] U.S. Food and Drug Administration. (2022). FDA approvals for Durvalumab.
[2] IQVIA. (2022). Global oncology market report.
[3] AstraZeneca. (2022). Imfinzi prescribing information.
[4] MarketWatch. (2022). Immunotherapy drugs market outlook.
[5] GlobalData. (2023). Biologics market projections.
