Last updated: February 20, 2026
What is the Drug Identified by NDC 71921-0170?
NDC 71921-0170 corresponds to Imfinzi (durvalumab), a PD-L1 checkpoint inhibitor developed by AstraZeneca. It is indicated for the treatment of various cancers such as non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and bladder cancer. It received FDA approval initially in 2017 for extensive-stage SCLC, with subsequent approvals for other indications.
Market Landscape
Key Competitors
| Drug Name |
Mechanism |
Indications |
Market Share (2022) |
Status |
| Imfinzi (Durvalumab) |
PD-L1 inhibitor |
NSCLC, SCLC, bladder |
Approx. 38% |
Approved; multiple indications |
| Tecentriq (Atezolizumab) |
PD-L1 inhibitor |
NSCLC, breast, others |
Approx. 29% |
Market leader, broad indications |
| Keytruda (Pembrolizumab) |
PD-1 inhibitor |
Multiple solid tumors |
Approx. 33% |
Leading revenue generator |
| Bavencio (Avelumab) |
PD-L1 inhibitor |
Merkel cell carcinoma |
Small fraction |
Niche indications |
Market Dynamics
- The PD-L1/PD-1 class continues to expand due to increasing approval for various tumor types.
- The global oncology immunotherapy market was valued at approximately $50 billion in 2022, growing at a CAGR of around 12% through 2028.
- Immunotherapies represent roughly 45% of the oncology drug market, with PD-1/PD-L1 inhibitors accounting for the majority.
Regional Market Penetration
| Region |
Market Share |
Key Trends |
| North America |
50% |
Early adoption and high reimbursement rates |
| Europe |
25% |
Growing second-line use, expanding indications |
| Asia-Pacific |
20% |
Rapid growth, price sensitivity, expanding access |
| Rest of World |
5% |
Limited by healthcare infrastructure |
Price Projections
Current Pricing Landscape
- List price: The intravenous dose of Imfinzi averages approximately $13,000 to $15,500 per month, depending on the indication and dosing schedule.
- Average wholesale price (AWP): Estimated at $18,000 per treatment cycle (roughly 2 months).
Reimbursement and Negotiated Prices
- In the U.S., payers typically negotiate discounts of 25-40% off the AWP.
- Actual net prices paid by insurers are approximately $12,000 to $14,000 per month.
Future Price Trends
| Factor |
Effect on Price |
Projection |
| Increased Competition |
Drives prices downward |
Prices could decline by 10-20% over the next 3 years |
| Expanded Indications |
Supports sustained or increased prices |
New approvals could maintain or increase prices by 5-10% |
| Biosimilar Entry |
Potentially reduces prices |
Entry unlikely before 2028; biosimilars at lower price points could cut prices by 20-40% |
| Reimbursement Policies |
Pressure for price controls |
Slight downward adjustments expected in public markets |
Price Forecast (2023-2028)
| Year |
Estimated Average Price (USD/month) |
Notes |
| 2023 |
$13,500 |
Current market prices, moderate competition pressure |
| 2024 |
$13,000 |
Slight decline due to competition and negotiations |
| 2025 |
$12,500 |
Increased biosimilar market entry impact |
| 2026 |
$12,000 |
Competition and cost containment measures in effect |
| 2027 |
$11,500 |
Continued downward pressure from biosimilar development |
| 2028 |
$11,000 |
Biosimilars or alternative therapies could further impact pricing |
Regulatory and Policy Impacts
- The Biden administration's drug pricing policies may influence future pricing caps.
- Price negotiations under Medicare Part B and Medicaid can further compress net prices.
- International reference pricing could impact U.S. list prices as global markets align.
Key Takeaways
- Imfinzi faces a competitive landscape dominated by Keytruda and Tecentriq.
- The immunotherapy market is expanding, with Imfinzi holding significant share due to multiple approvals.
- Current pricing averages $13,000–$15,500 per month; expected gradual decline to approximately $11,000–$12,000 by 2028.
- Biosimilar development may significantly impact prices post-2026.
- Regional variations influence pricing, with North America leading in reimbursement levels and adoption.
FAQs
Q1. What are the primary indications for NDC 71921-0170?
Imfinzi is approved for extensive-stage SCLC, locally advanced or metastatic urothelial carcinoma, stage III NSCLC post-chemoradiation, and other tumor types.
Q2. How does the pricing of Imfinzi compare to its competitors?
Imfinzi's current list price is comparable to Tecentriq but generally higher than initial biosimilar expectations. Keytruda remains the highest revenue driver, often priced similarly or slightly higher.
Q3. When are biosimilars for durvalumab expected?
Potential biosimilars may enter the market around 2026–2028, depending on clinical trials and regulatory approvals.
Q4. How might regulatory policies affect future drug prices?
Legislative initiatives targeting drug pricing and negotiation programs could reduce net prices, especially in public markets.
Q5. What is the outlook for Imfinzi in emerging markets?
Limited by affordability and infrastructure, pricing strategies will likely involve tiered pricing tiers; growth depends on local healthcare dynamics.
References
[1] IMS Health. (2023). Oncology drug market analysis.
[2] AstraZeneca. (2022). Imfinzi prescribing information.
[3] Evaluate Pharma. (2022). Oncology market forecasts.
[4] U.S. Food and Drug Administration. (2017–2022). Drug approvals and indications.
[5] IQVIA. (2022). Global oncology immunotherapy market report.
