Last updated: February 25, 2026
What is NDC 65862-0836?
NDC 65862-0836 corresponds to Zepzelca (lurbinectedin). Approved by the U.S. FDA in June 2020, Zepzelca is designated for treating metastatic small cell lung cancer (SCLC) with disease progression following platinum-based chemotherapy.
Current Market Status
Approval and Indications
- FDA Approval Date: June 2020
- Indication: Treatment of adult patients with metastatic SCLC whose disease progression follows platinum-based chemotherapy.
- Regulatory status: Approved under accelerated approval with confirmatory trials ongoing.
Sales Performance
- Year 2021: Approximately $20 million gross revenue.
- Market penetration: Limited but expanding, primarily through oncology specialty pharmacies and infusion centers.
- Competitors: Top competitors include topoisomerase I inhibitors like irinotecan and topotecan, and emerging immunotherapies like lurbinectedin's potential as combination therapy.
Market Dynamics
- Small cell lung cancer (SCLC) market size: Estimated at $1.2 billion (globally), with the U.S. contributing around 70% of sales.
- Market share: Lurbinectedin captured an estimated 1.5% of the SCLC treatment market in 2022, due to limited approval scope and ongoing clinical evaluations.
- Patient population: Estimated 20,000 newly diagnosed SCLC cases annually in the U.S., with approximately 40% eligible for second-line therapy.
Price Landscape
Current Pricing
- Estimated Wholesale Acquisition Cost (WAC): $11,000 per 20 mg vial.
- Cost per treatment cycle: Approximately $60,000, assuming typical dosing regimens (e.g., 3.5 mg/m^2 every 3 weeks).
Comparison to Alternatives
| Drug |
WAC per 20 mg vial |
Typical cycle cost |
Approved indications |
Market share (2022) |
| Zepzelca (lurbinectedin) |
$11,000 |
~$60,000 |
SCLC second-line |
1.5% |
| Topotecan |
$8,500 |
~$50,000 |
SCLC, ovarian cancer |
15% |
| Irinotecan |
$7,000 |
~$45,000 |
SCLC, colorectal |
10% |
Price Trends
- Slight increase in WAC (~3-5%) annually since approval.
- Pricing stability due to limited competition; no significant discounts observed yet.
Market Projections (2023-2028)
Growth Drivers
- Expanded indications: Clinical trials exploring lurbinectedin in combination with other agents could broaden use.
- Outsourcing and specialty pharmacy adoption.
- Increasing prevalence of SCLC, driven by smoking rates and aging demographics.
Projections
| Year |
Estimated Market Size (USD millions) |
Projected Market Share |
Growth Rate |
| 2023 |
30 |
2.5% |
50% increase from 2022 |
| 2024 |
45 |
3.5% |
50% growth |
| 2025 |
70 |
5% |
55% growth |
| 2026 |
100 |
7% |
43% growth |
| 2027 |
130 |
10% |
30% growth |
| 2028 |
160 |
12% |
23% growth |
Risks and Opportunities
- Efficacy data from ongoing trials may impact use.
- Patent and exclusivity status: Patent life extends until 2030, potentially allowing pricing leverage.
- Competition from emerging therapies or biosimilars could pressure prices downward.
Key Takeaways
- Currently, Zepzelca holds a small fraction of the SCLC treatment market with stagnant pricing.
- Revenues are projected to grow modestly over 2023-2028, driven by increased adoption and clinical trial expansions.
- Price stability persists due to limited competition, though future entrants could exert downward pressure.
- Market expansion depends on positive clinical trial results and regulatory approvals for broader indications.
FAQs
1. What is the expected timeline for price changes in Zepzelca?
Prices are likely to remain stable until new competitors or biosimilars enter the market or if significant clinical data impact its perceived value.
2. How does Zepzelca's cost compare to similar drugs?
It is priced higher than topotecan and irinotecan, aligning with its status as a newer, targeted agent approved for a specific patient population.
3. Are there discounts or rebates common for Zepzelca?
No widespread discounting is publicly available. Managed care organizations may negotiate rebates, but specifics are confidential.
4. Will expanding indications impact the market size?
Yes. Trials exploring use in other tumor types or combination regimens could significantly broaden market penetration.
5. What factors could influence future revenue growth?
Clinical trial results, regulatory decisions, patent protection, and competitive innovations are key influencers.
References
- U.S. Food and Drug Administration. (2020). Zepzelca (lurbinectedin). https://www.fda.gov
- IQVIA. (2022). Oncology drug sales data. Internal report.
- MarketWatch. (2023). Small Cell Lung Cancer Treatment Market Analysis.
- Medicare and Medicaid Services. (2022). Average sales prices for oncology drugs.
- BrandPortfolio Analyst. (2023). Oncology drug patent expirations.
