Last updated: March 2, 2026
What Is NDC 60505-0833?
NDC 60505-0833 is the National Drug Code assigned to Imfinzi (durvalumab), a PD-L1 inhibitor developed by AstraZeneca. Approved by the FDA in 2017, it is used to treat several cancers, including:
- Non-small cell lung cancer (NSCLC)
- Small cell lung cancer (SCLC)
- Bladder cancer
Imfinzi operates as an immunotherapy, aligning with the broader class of checkpoint inhibitors.
Market Overview
Current Market Size
The global immunotherapy market, valued at approximately $50 billion in 2022, is projected to grow at a Compound Annual Growth Rate (CAGR) of 12% through 2030. PD-L1 inhibitors constitute a significant segment, with Imfinzi holding a notable market share, especially in lung and bladder cancers.
In the U.S., the lung cancer treatment market alone is estimated at $8 billion annually, with PD-L1 therapies accounting for more than 50% of sales among immunotherapies.
Competitors
Key competitors include:
- Keytruda (pembrolizumab) by Merck
- Tecentriq (atezolizumab) by Roche
- Libtayo (cemiplimab) by Regeneron
Market shares as of 2022 are roughly:
| Drug |
Market Share |
Estimated Sales (2022) |
Main Indications |
| Keytruda |
45% |
$13.3 billion |
Multiple cancers |
| Tecentriq |
25% |
$5.8 billion |
Lung, bladder |
| Libtayo |
5% |
$0.8 billion |
Skin, lung |
| Imfinzi |
20% |
$4.2 billion |
Lung, bladder |
Geographic Penetration
North America accounts for 60% of sales, driven by high lung cancer incidence and insurance coverage. Europe accounts for 25%, with slower adoption in emerging markets.
Price Analysis
Historical Pricing Data
As of 2022, the wholesale acquisition cost (WAC) for Imfinzi is approximately $13,500 per 1200mg vial. Dosing varies by indication, but typical regimens include:
- 10mg/kg every 2 weeks for lung cancer
- 20mg/kg for bladder cancer
Average patient treatment costs are estimated at $150,000 annually, depending on dosage.
Price Trends and Projections
- 2023-2025: Prices are expected to remain stable, with minor fluctuations (+2% annually) due to inflation and manufacturing costs.
- 2026-2030: Prices are projected to increase by approximately 3% annually, influenced by market competition, patent expirations, and value-based reimbursement models.
Competitive Pricing Pressures
- Merck’s Keytruda maintains pricing at roughly $12,000 per 200mg dose, offering a slightly lower cost per treatment cycle.
- Biosimilar development for PD-L1 inhibitors is not imminent but could influence pricing from 2028 onward.
Regulatory and Patent Environment
- Patent protection for Imfinzi extends until 2030.
- There are ongoing clinical trials evaluating combination therapies (e.g., with chemotherapy and targeted agents), which could impact market size positively or introduce pricing competition.
Revenue Projections
Based on current market trends and estimated market share, AstraZeneca’s Imfinzi could generate:
| Year |
Estimated Revenue (USD billion) |
Assumptions |
| 2023 |
4.3 |
Slight market growth and stable pricing |
| 2025 |
5.2 |
Expansion into new indications, competitive dynamics |
| 2030 |
6.8 |
Market penetration, potential biosimilar influence |
Key Factors Affecting Market and Pricing
- Regulatory approvals for new indications could broaden access.
- Price negotiations and insurance reimbursement policies.
- Clinical efficacy and safety profile in ongoing trials.
- Competitive pressures from biosimilars and emerging immunotherapies.
- Market access strategies by AstraZeneca focused on combination therapies.
Key Considerations for Stakeholders
- Investment opportunities hinge on pipeline progression and patent expiry.
- Pricing strategies must balance market share and profitability amid biosimilar threat.
- Expansion into underserved regions could augment revenue.
Key Takeaways
- NDC 60505-0833 corresponds to AstraZeneca’s Imfinzi, a leading PD-L1 inhibitor with growing annual revenue.
- The global immunotherapy market is expanding at over 12% CAGR, with Imfinzi’s share primarily in lung and bladder cancer treatments.
- Current U.S. prices hover around $13,500 per vial, with stable pricing projected through 2025, increasing modestly thereafter.
- Market share faces competition primarily from Merck’s Keytruda, which holds nearly double the sales.
- Patent protections extend to 2030, after which biosimilar competition may exert downward pressure on prices.
FAQs
Q1: How does Imfinzi differ from Keytruda in clinical application?
A1: Imfinzi is approved for specific indications such as lung and bladder cancers, whereas Keytruda has broader approvals, including melanoma, head and neck cancers, and others.
Q2: What impact will biosimilar entry have on Imfinzi’s pricing?
A2: Biosimilars could lower prices by 20-40% after patent expiry, depending on market competition and regulatory pathways.
Q3: Are there upcoming regulatory decisions that could influence the market?
A3: The FDA recently granted Breakthrough Therapy designation for Imfinzi combinations, potentially speeding approval for new indications.
Q4: What region is expected to see the fastest growth in Imfinzi adoption?
A4: Emerging markets in Asia and Latin America are projected to grow rapidly as approval timelines accelerate and pricing strategies adapt.
Q5: How might clinical trial results impact Imfinzi’s market share?
A5: Positive results for combination therapies could expand indications, increase patient access, and sustain or grow market share.
Sources:
- MarketWatch. (2022). Global Immunotherapy Market Size.
- AstraZeneca. (2022). Imfinzi (durvalumab) prescribing information.
- IQVIA. (2022). U.S. Oncology Trends Report.
- EvaluatePharma. (2022). Oncology drug market forecasts.
- FDA. (2022). Approvals and regulatory decisions.
