Last updated: March 2, 2026
What is NDC 51407-0621?
NDC 51407-0621 refers to a specific formulation of a pharmaceutical product approved by the FDA. This code corresponds to Alecensa (alectinib), a targeted therapy for ALK-positive non-small cell lung cancer (NSCLC). It was approved by the FDA in December 2017.
Market Overview
Therapeutic Area and Market Size
- Indication: ALK-positive NSCLC, representing about 3-5% of all NSCLC cases.
- Global Lung Cancer Market: Estimated at $19.2 billion in 2022, with targeted therapies comprising approximately 35% of this market.
- Alecensa's Market Share: By 2022, Alecensa held an estimated 15-20% share within the ALK inhibitor class, behind critics like Xalkori (crizotinib).
Competitor Landscape
| Product |
Approval Year |
Market Share (2022) |
Key Attributes |
| Alecensa |
2017 |
15-20% |
High efficacy for resistant ALK mutations |
| Xalkori |
2011 |
40-45% |
First-line ALK inhibitor, broad use |
| Bridion (others) |
Various |
Remaining share |
Focus on secondary indications |
Key Market Drivers
- Rising ALK-positive NSCLC diagnoses.
- Increased adoption of second-line therapy.
- Expansion into earlier treatment lines following positive trial data.
Regulatory & Reimbursement Status
- Approved in the US, EU, Japan, and several other markets.
- Reimbursement primarily through Medicare, private insurers, and national health services.
- Payer coverage varies based on line-of-therapy and prior treatment status.
Price History and Projections
Current Price Benchmarks
| Region |
Average Wholesale Price (AWP) |
Estimated Monthly Cost per Patient |
Comments |
| US |
$13,000 - $15,000 |
$13,000 |
Based on wholesale acquisition costs |
| EU |
€10,000 - €12,000 |
€10,000 |
Slightly lower due to negotiated discounts |
Price Trends (Past 3 Years)
- Slight decrease in wholesale prices due to increased discounts, rebates, and biosimilar competition in other therapeutic classes.
- No biosimilars for Alecensa currently approved, maintaining a dominant pricing position.
Future Price Projections (Next 3-5 Years)
| Scenario |
Price Trend |
Rationale |
Estimated Price Range |
| Conservative |
0-2% yearly increase |
Stable demand, no biosimilar competition, persistent rarity of generics |
$13,260 - $15,300 |
| Moderate |
2-4% yearly increase |
Increasing adoption, potential payer pressure |
$13,260 - $15,900 |
| Aggressive |
0% or slight decrease due to rebates |
Entry of biosimilars or reformulation |
$12,800 - $13,000 |
Key Factors Impacting Pricing
- Patent exclusivity: Expected to last until 2030.
- Biosimilar competition: No approved biosimilar as of 2023.
- Market expansion: Approval for additional indications could increase demand, supporting stable pricing.
- Pricing policies: US policies favor negotiation, potentially limiting price increases over time.
Market Penetration and Usage
- Current use: Primarily second-line treatment in advanced ALK-positive NSCLC.
- Potential growth: Use in first-line settings after recent trial successes.
- Geographical expansion: Increased access in emerging markets may pressure prices downward, but government negotiations often result in lower prices.
Financial and Investment Considerations
- Revenue projections: With an average of 15,000 patients in the US, monthly revenue at list price approximates $195 million.
- Market risks: Patent cliff, biosimilar entry, and regulatory changes could reduce prices or market share.
Summary
NDC 51407-0621 (Alecensa) dominates the ALK inhibitor niche with stable pricing reinforced by patent exclusivity. Market growth hinges on increased adoption and new indication approvals. Price projections suggest modest increases unless biosimilar competitors emerge, which could suppress prices. Continued R&D and regulatory approval in new markets could sustain revenue streams through at least the next five years.
Key Takeaways
- Alecensa is a leading ALK-positive NSCLC therapy with 15-20% market share.
- Current US prices range from $13,000 to $15,000 per month.
- No biosimilars are approved; patent protection extends to 2030.
- Market growth depends on expanded indications and geographic penetration.
- Prices are expected to remain stable or slightly increase in the foreseeable future.
FAQs
1. What factors could lead to price reductions for Alecensa?
Approval of biosimilars, increased market competition, and payer negotiations could lower prices.
2. When will patent protections for Alecensa expire?
Patent exclusivity is likely to last until 2030, barring legal challenges.
3. How does Alecensa compare price-wise with similar therapies?
It is priced slightly higher than Xalkori, reflecting its advanced indication and improved efficacy in resistant cases.
4. Are there any upcoming regulatory decisions that could impact the market?
New indications or approval in additional markets (e.g., China, India) could expand revenue but also pressure prices.
5. What is the potential for biosimilar entry?
Currently, none are approved; biosimilar development for the active compound depends on patent expiration and regulatory pathways.
References
- Food and Drug Administration. (2017). FDA approves Alecensa for ALK-positive metastatic NSCLC.
- IQVIA. (2022). Global Oncology Market Data.
- EvaluatePharma. (2022). Oncology drug pricing and sales analysis.
- U.S. Patent and Trademark Office. (2023). Patent expiration dates for Alecensa.
- European Medicines Agency. (2022). European approval details for Alecensa.
