Last updated: February 25, 2026
What is NDC 61442-0142?
NDC 61442-0142 is an injectable formulation of durvalumab (Imfinzi), a PD-L1 inhibitor used in the treatment of certain cancers. It was approved by the FDA in 2017 for the treatment of urothelial carcinoma and non-small cell lung cancer (NSCLC).
Market Overview
Durvalumab is part of the immune checkpoint inhibitor class, competing with approved drugs such as pembrolizumab and atezolizumab. It targets PD-L1, enabling the immune system to attack tumor cells.
Indications and Approved Uses
- Unresectable Stage III NSCLC (first-line maintenance, post-chemoradiation)
- Extensive-stage small cell lung cancer (ES-SCLC)
- Certain urothelial carcinomas
Market Size (2023)
The global oncology monoclonal antibody market was valued at approximately $70 billion in 2022 and is projected to reach $110 billion by 2027, growing at a CAGR of 9%. Durvalumab holds a significant share within this segment due to expanded indications.
Competitive Landscape
Key competitors:
- Pembrolizumab (Keytruda)
- Atezolizumab (Tecentriq)
- Nivolumab (Opdivo)
Market penetration varies by indication, with pembrolizumab leading in NSCLC.
Key Markets
- United States: Largest revenue base, driven by expanded indications and high prevalence of lung cancer.
- Europe: Growing adoption, limited by pricing and reimbursement policies.
- Asia-Pacific: Increasing use, especially in Japan and China, due to rising cancer incidence and expanding approvals.
Price History and Regulatory Pricing Environment
U.S. Pricing
- Average wholesale price (AWP): ~$4,200 per 200 mg vial (as of 2023)
- Reimbursement typically aligned with Medicare and Medicaid pricing, with payers negotiating discounts.
Market Access Factors
- CMS pricing influences reimbursement for hospital-administered formulations.
- GPOs and hospital systems negotiate retrospective discounts.
- Price competition from biosimilars is limited; no biosimilars for durvalumab approved as of 2023.
Pricing Trends
- Prices for immunotherapies have increased steadily since FDA approval.
- Payer pressure has limited list price growth to approximately 3-5% annually over the past five years.
Price Projections (2024-2028)
| Year |
Estimated Price per 200 mg Vial |
Comments |
| 2024 |
$4,350 |
Minimal increase reflecting inflation and negotiations |
| 2025 |
$4,500 |
Slight increase expected, assuming stable manufacturing costs |
| 2026 |
$4,650 |
Market saturation pressures limit rapid price growth |
| 2027 |
$4,800 |
Slight margin expansion as patent protection persists |
| 2028 |
$4,950 |
Preparation for potential biosimilar entry or new competition |
Increased competition, especially from biosimilars, could reduce prices post-2028, but as of now, no biosimilar approvals are projected before 2030.
Revenue Projections
Assuming a healthcare utilization rate of 15,000 patients annually in the U.S., with average treatment courses of 4 discontinuous doses, and stable pricing:
| Year |
Estimated Revenue (USD billions) |
Assumptions |
| 2024 |
$1.3 |
10% market share of eligible NSCLC patients |
| 2025 |
$1.4 |
Market penetration increases by 5% |
| 2026 |
$1.5 |
Expanded indication access |
| 2027 |
$1.5 |
Plateau due to market saturation |
| 2028 |
$1.4 |
Competitive pressures influence price and volume |
Regulatory and Policy Impact
Reimbursement policies, especially in public sectors, influence actual net prices. The shift toward value-based pricing in oncology therapeutics could compress margins further.
Key Takeaways
- The total market for durvalumab (NDC 61442-0142) remains robust due to growing cancer prevalence and expanded indications.
- U.S. list prices are approximately $4,200 per 200 mg vial, with modest annual increases.
- Market penetration and reimbursement policies heavily influence revenue; biosimilar competition may impact pricing and market share in the next 5–7 years.
- Revenue projections indicate growth through 2025, then plateauing due to saturation and competitive factors.
FAQs
-
What are the primary indications for durvalumab (NDC 61442-0142)?
It is approved for unresectable Stage III NSCLC, small cell lung cancer, and urothelial carcinoma.
-
How does durvalumab's market share compare to competitors?
It holds a smaller share than pembrolizumab but benefits from niche indications and recent expansion.
-
Are biosimilars expected for durvalumab?
No biosimilars are approved as of 2023; potential entry is expected beyond 2029, subject to regulatory approvals.
-
What factors influence the pricing of durvalumab?
Factors include negotiation with payers, manufacturer costs, competition, and regulatory policies.
-
What is the outlook for durvalumab's revenue in the coming years?
Revenue is projected to grow modestly through 2025 as market share expands but will likely plateau with increased competition and biosimilar development.
References
- IQVIA. (2023). Global oncology market report.
- U.S. Food and Drug Administration. (2017). FDA approval announcement for durvalumab.
- Centers for Medicare & Medicaid Services. (2023). Pricing and reimbursement policies.
- EvaluatePharma. (2022). Oncology monoclonal antibody market forecast.
- FDA. (2023). Biosimilar approvals and pipeline.
