Last updated: March 1, 2026
What is the drug identified by NDC 64380-0169?
The National Drug Code (NDC) 64380-0169 corresponds to Imfinzi (durvalumab), a monoclonal antibody developed by AstraZeneca. It is approved for multiple indications, including metastatic urothelial carcinoma and unresectable Stage III non-small cell lung cancer (NSCLC). It functions as an immune checkpoint inhibitor targeting PD-L1.
Market Overview
Indications and Approved Uses
- Unresectable Stage III NSCLC (approved in 2018)
- Extensive-stage small cell lung cancer (SCLC), approved in 2020
- Urothelial carcinoma, including bladder cancer, approved in 2017
- Other potential immunotherapy combinations and trials under evaluation
Market Size and Growth Drivers
- Lung cancer remains the second most diagnosed cancer worldwide, with an estimated 2.2 million cases in 2020.
- The global lung cancer therapeutics market value was approximately $5.5 billion in 2022, expected to grow at a CAGR of 10% through 2030 (Fortune Business Insights).
- Immune checkpoint inhibitors hold a dominant share, with PD-L1 inhibitors like durvalumab capturing increasing demand.
- The unmet need in bladder and lung cancers fuels R&D and market expansion.
Competitive Landscape
Key competitors include:
- Pembrolizumab (Keytruda, Merck)
- Atezolizumab (Tecentriq, Roche)
- Nivolumab (Opdivo, Bristol-Myers Squibb)
- Avelumab (Bavencio, Pfizer/BMS)
Durvalumab's unique combination approvals and marginally differentiated efficacy influence market share dynamics.
Revenue and Sales Trends
- AstraZeneca reported global sales of Imfinzi at approximately $2.4 billion in 2022.
- The US accounted for roughly 70% of sales, propelled by high approval rates and approved indications.
- Sales growth hinges on expanding indications and commercial acceptance in emerging markets.
Price Analysis and Projections
Current Pricing
As of Q1 2023, the average wholesale price (AWP) for a 1200 mg dose of durvalumab (which aligns with a typical 10 mg/kg dose for a 60 kg patient) ranges from $7,500 to $9,000 per infusion. Net prices are lower, considering discounts and rebates.
Factors Influencing Price Convergence
- Biosimilar development is limited due to complexity, delaying significant price reduction.
- Manufacturing costs and patent protections sustain high pricing.
- Competitive pressures from other PD-L1 inhibitors exhibit minor impact on durvalumab pricing in the short term.
Price Trend Projection (2023-2028)
| Year |
Estimated Price Range (per infusion) |
Key Factors |
| 2023 |
$7,500 - $9,000 |
Steady pricing influenced by patent protection; high demand persists |
| 2024 |
$7,000 - $8,800 |
Slight discounting as market stabilizes; increased utilization |
| 2025 |
$6,800 - $8,600 |
Emergence of biosimilar research may prompt marginal lowering |
| 2026 |
$6,500 - $8,400 |
Potential biosimilar approvals; price competition intensifies |
| 2027 |
$6,200 - $8,200 |
Biosimilar entry could reduce prices further; market expansion continues |
| 2028 |
$6,000 - $8,000 |
Long-term stabilization with competitive biosimilar presence |
Revenue Projections
Based on current market penetration and growth estimates, AstraZeneca could sustain 10-15% CAGR in sales volume, with prices averaging around $6,000–$8,000 per dose by 2028. Total global sales could reach $5–6 billion annually, factoring in expanded indications and geographic penetration.
Regulatory and Policy Impact
- Patent expiration scheduled around 2030, with some biosimilar trials underway.
- Several health authorities (e.g., FDA, EMA) are increasingly favorable towards biosimilars, influencing future pricing and substitution policies.
- Price negotiations in countries with national healthcare systems may lead to discounts averaging 20–30%.
Summary
Durvalumab (NDC 64380-0169) remains a high-value immunotherapy agent with stable pricing driven by patent exclusivity, demand for lung and bladder cancers, and limited biosimilar competition. Revenue growth is expected to continue, supported by expanding indications and geographic reach. Price projections suggest modest declines aligned with biosimilar advancements and competitive market dynamics, but the drug’s premium status will likely persist through 2028.
Key Takeaways
- Durvalumab's market is driven by lung and bladder cancer indications.
- Sales reached approximately $2.4 billion globally in 2022.
- Current infusion prices range from $7,500 to $9,000; projected to decline gradually to around $6,000–$8,000 by 2028.
- Biosimilar competition is limited now but expected to influence pricing beginning mid-decade.
- Patent expiration around 2030 may create shifts in pricing and market share.
FAQs
Q1: How does durvalumab compare competitively to similar PD-L1 inhibitors?
A: It is comparable in efficacy and safety to pembrolizumab and atezolizumab but faces challenges from biosimilar entrants and market share competition.
Q2: What factors could accelerate price declines?
A: Biosimilar approvals, regulatory changes favoring cost reductions, and increased market competition.
Q3: Are there regional pricing differences?
A: Yes. Pricing is generally higher in the US due to market dynamics and lower in countries with national healthcare systems negotiating prices.
Q4: What is the impact of new indications on sales growth?
A: Additional approvals, such as combinations in other cancers, can significantly increase market size and revenue streams.
Q5: When might biosimilar versions of durvalumab become available?
A: Trials are ongoing, but biosimilar competitors may enter the market around 2025–2026, influencing long-term pricing strategies.
References
[1] Fortune Business Insights. (2022). Global Lung Cancer Therapeutics Market.
[2] AstraZeneca. (2023). Imfinzi (durvalumab) Prescribing Information.
[3] IQVIA. (2023). Biopharma Market Data.
[4] FDA. (2022). Approved Drugs Database.
[5] European Medicines Agency. (2022). Marketing Authorization for Durvalumab.
