Last updated: February 17, 2026
What is the current market status for NDC 00904-7377?
NDC 00904-7377 corresponds to Durvalumab (brand name Imfinzi), an immune checkpoint inhibitor used in treatment of various cancers, notably non-small cell lung cancer (NSCLC) and urothelial carcinoma. It received FDA approval for multiple indications starting in 2017 and is marketed by AstraZeneca.
The drug's market penetration varies across regions but has seen increasing adoption in the oncologic treatment landscape due to its efficacy. As of 2023, it is included in standard treatment protocols, especially in combination regimens with chemotherapy or other immunotherapies.
How is Durvalumab positioned in the oncology market?
Durvalumab competes with similar immunotherapies such as pembrolizumab (Keytruda), nivolumab (Opdivo), and atezolizumab (Tecentriq). Its primary advantage is activity in specific indications like unresectable stage III NSCLC after chemoradiotherapy.
Market share:
- In 2022, Durvalumab accounted for approximately 15-20% of the PD-1/PD-L1 inhibitor market in the U.S.
- Global sales reached approximately $1.65 billion in 2022, with expectations to grow at a compound annual growth rate (CAGR) of 8-10% over the next five years.
What are the key factors influencing pricing?
Drug pricing for Durvalumab varies by region, insurance coverage, and indication. As of 2023:
- U.S. Average Wholesale Price (AWP): Approximately $9,600 to $12,000 per 600 mg dose.
- European Union: Pricing ranges from €5,000 to €7,500 per dose, with negotiations and discounts affecting net prices.
- Pricing trends are influenced by competitive dynamics, patent status, and value-based pricing models.
Reimbursement policies play critical roles, with payers increasingly demanding value-based agreements and outcomes-based pricing.
What are the projected price trends?
Based on current industry patterns and patent considerations:
- Patent expiration: Expected around 2028-2030, after which biosimilar versions could enter the market.
- Biosimilar impact: Biosimilar entries may reduce prices by 20-40% over existing branded drug prices.
- Pricing trajectory: Pre-patent expiry, prices are expected to remain stable or increase marginally due to inflation and R&D costs. Post-patent, prices could fall sharply with biosimilar competition.
What is the future market outlook for Durvalumab?
Potential growth avenues include:
- Expanded indications (e.g., small cell lung cancer, breast cancer, head and neck cancers).
- Combination therapies increasing clinical utility and, consequently, pricing premiums.
- Geographic expansion into emerging markets, where pricing sensitivity could depress revenue per dose but increase market penetration.
Projected revenue for Durvalumab could reach $2.5-$3.5 billion annually by 2028, assuming growth in indications and geographical markets.
What are the key revenue and price projection estimates?
| Year |
Revenue Projection |
Price Estimate (per 600 mg dose) |
Comments |
| 2023 |
$1.65 billion |
$10,000 |
Current market, stable pricing |
| 2025 |
$2.2 billion |
$10,000-$11,000 |
Growth from expanded indications and adoption |
| 2028 |
$3.2 billion |
$8,000-$9,500 |
Approaching patent expiry, biosimilar entry anticipated |
(Note: These figures are estimates based on industry trends, clinical adoption, and patent horizon calculations.)
Key Takeaways
- Durvalumab remains a significant player in immuno-oncology with increasing sales and expanded indications.
- Central influences include clinical efficacy, competition, patent protections, and healthcare reimbursement reforms.
- Prices are expected to hold steady until patent expiration, after which biosimilars will likely cause prices to decline.
- Revenue growth prospects hinge on indication expansion and geographic penetration.
- Strategic market positioning involves balancing innovation, patent management, and cost-effective access.
FAQs
1. When will biosimilars for Durvalumab likely enter the market?
Biosimilars are expected around 2028-2030, aligned with patent expiration timelines.
2. How does Durvalumab compare price-wise with other PD-L1 inhibitors?
Durvalumab’s current prices are comparable to atezolizumab but generally higher than bioscaling estimates of biosimilar versions once available.
3. What factors could accelerate pricing declines?
Patent challenges, biosimilar entry, and increased government pressure for cost containment can accelerate price reductions.
4. What are the most significant growth areas for Durvalumab?
Expanded indications, combination therapies, and markets in emerging economies present growth opportunities.
5. How will reimbursement trends impact Durvalumab's market share?
Shift toward outcome-based reimbursement may influence net pricing but could also incentivize broader access given clinical benefits.
Sources:
- AstraZeneca. Imfinzi (Durvalumab) Prescribing Information. 2023.
- EvaluatePharma. Oncology Market Data 2022.
- IQVIA. U.S. Oncology Trends 2023.
- FDA. Approval and indication history. 2017 onward.
- Industry reports on biosimilar launches and market forecasts.
