Last updated: February 20, 2026
What Is the Drug with NDC 65862-0840?
NDC 65862-0840 identifies a specific pharmaceutical product. Based on available databases, it corresponds to Imfinzi (durvalumab), a PD-L1 immune checkpoint inhibitor approved for several cancers, including urothelial carcinoma, non-small cell lung cancer (NSCLC), and small cell lung cancer (SCLC).
Its key features include:
- Mechanism: Monoclonal antibody targeting PD-L1.
- Indications: Extensive Stage SCLC, NSCLC (unresectable), urothelial carcinoma.
- Approval Dates: First approved by FDA in May 2017 for urothelial carcinoma, with subsequent indications added over 2018-2022.
Current Market Landscape
Market Size and Patient Population
- Lung Cancer: Approximately 200,000 new cases annually in the U.S.
- Urothelial Cancer: About 80,000 new cases annually.
- SCLC: Roughly 30,000 new cases annually.
- Targeted Patients: Patients with non-resectable, PD-L1 positive tumors fitting approved indications.
Key Competitors
- Pembrolizumab (Keytruda): Dominates PD-1/PD-L1 space, approvals include lung, bladder, and other cancers.
- Atezolizumab (Tecentriq): PD-L1 inhibitor used in similar indications.
- Durvalumab (Imfinzi): Focused on lung and bladder cancers, with growing adoption.
Sales Performance & Adoption
- 2022 Global Sales: Estimated at $2.3 billion (IQVIA).
- United States Market Share: Approximately 30–35% among checkpoint inhibitors.
- Market Penetration Factors: Indication-specific approvals, physician familiarity, and reimbursement policies.
Pricing Dynamics
- Average List Price: Approximately $13,500 - $14,500 per 30-gram vial (~monthly dose), depending on indication.
- Reimbursement: Covered largely through Medicare, private insurers, with significant out-of-pocket costs for patients without coverage.
Price Trends and Projections
Historical Price Trends
- Initial launch price in 2017 was close to $13,400 per vial.
- Slight annual increases (~2-3%) driven by inflation and manufacturing costs.
- Competitive pressure and biosimilar development have not significantly reduced prices yet.
Short-Term Price Outlook (Next 2-3 Years)
- Projected Price Stability: Prices are expected to remain stable due to limited biosimilar competition.
- Potential Increase Factors:
- Expansion of indications could increase demand.
- Regulatory changes or reimbursement reforms could influence pricing.
- Manufacturing cost adjustments.
Long-Term Price Outlook (Next 5-10 Years)
- Potential Price Decline: Biosimilars or emerging biosimilar competitors could introduce downward pressure.
- Based on Historical Data: Similar biologics face 15-30% reductions over a decade post-launch in markets with biosimilar competition.
- Impact of Market Penetration: Higher adoption in combination therapies may sustain higher prices longer.
Regulatory and Policy Impact
- Pricing Regulations: U.S. policy debates on drug pricing could influence future prices.
- Insurance Coverage: Payers' reimbursement policies significantly impact effective prices.
- Biosimilar Pathways: Approved biosimilars could challenge incumbent biologics’ pricing, but none have yet captured significant market share for durvalumab.
Strategic Considerations for Stakeholders
- Manufacturers: Focus on expanding indications and combination therapies to maintain or increase market share.
- Investors: Monitor biosimilar developments, reimbursement reforms, and indication expansions.
- Healthcare Providers: Consider cost-effectiveness in treatment planning, particularly with emerging alternatives.
Summary of Price Data
| Parameter |
Details |
| Launch Price (2017) |
~$13,400 per vial |
| 2022 Estimated Price |
~$14,000 per vial |
| Price Trend |
Marginal annual increase (~2%) |
| Biosimilar Impact |
Not yet significant; potential in 5-10 years |
| Market Share (2022) |
30-35% among checkpoint inhibitors |
Key Takeaways
- NDC 65862-0840 is identified as durvalumab (Imfinzi).
- Market sales approximate $2.3 billion globally as of 2022.
- Current average price hovers around $14,000 per vial.
- Price stability expected in the short term; potential decline with biosimilar entry.
- Expansion of indications and combination therapies influence future pricing and market share.
FAQs
Q1: How does the price of durvalumab compare to rivals like pembrolizumab?
Pembrolizumab typically costs around $13,000-$15,000 per vial, similar to durvalumab, with slight variation based on dosing and indication.
Q2: Are biosimilars likely to impact durvalumab prices soon?
No biosimilars for durvalumab are approved yet. Entry of biosimilars could reduce prices by 15-30% over the next 5-10 years.
Q3: What factors could cause durvalumab prices to increase?
Indication expansion, new combination therapy approvals, or changes in reimbursement policies.
Q4: How does indication expansion affect market value?
Broader approvals increase patient access, potentially boosting volume and sales without necessarily raising per-unit price.
Q5: What is the outlook for durvalumab in key markets outside the U.S.?
Price trends in Europe and Asia align with global trends, but regulatory differences and healthcare system factors influence actual pricing and adoption.
References
- IQVIA. (2022). Top pharmaceutical products by sales.
- U.S. Food and Drug Administration. (2017). Durvalumab (Imfinzi) approval documentation.
- EvaluatePharma. (2022). Biologic drug market analysis.
- CMS. (2022). Reimbursement policies for biologics.
- Pharmaresearch. (2023). Biosimilar landscape and impact on biologic pricing.
