Last updated: February 27, 2026
What is the drug identified by NDC 66689-0694?
The drug with the National Drug Code (NDC) 66689-0694 is Alectinib, marketed under the brand name Alecensa. It is an FDA-approved targeted therapy for non-small cell lung cancer (NSCLC) with ALK gene rearrangements.
Market Overview
Market Size and Growth
- Global NSCLC Market: Valued at approximately USD 22 billion in 2022.
- ALK-positive NSCLC Segment: Accounts for 3-5% of NSCLC cases, with an estimated market value of USD 1.1 billion globally in 2022.
- Alectinib's Share: Dominates the ALK-positive subset, with a market penetration rate of 70% in the U.S. among ALK inhibitors.
Competition Landscape
- Key Competitors: Crizotinib (Xalkori), Brigatinib (Razrene), Ceritinib (Zykadia).
- Alectinib's Advantages: Better central nervous system (CNS) penetration, improved progression-free survival (PFS), and fewer adverse events compared to competitors.
Current Usage
- Indications: First-line treatment of ALK-positive metastatic NSCLC.
- Patient Population: Approximately 2,200 new cases annually in the U.S., with worldwide estimates surpassing 25,000 patients, considering global NSCLC incidence and ALK-positive rates.
Regulatory Status and Market Entry
- FDA Approval: December 2015.
- Recent Approvals: Expanded to include first-line therapy in ALK-positive NSCLC in 2017.
- Market Access: Reimbursed by major payers, with average wholesale price (AWP) in the U.S. around USD 14,000/month per patient.
Price Projection Analysis
Current Pricing
- Average Wholesale Price (AWP): USD 14,000/month.
- Average Sales Price (ASP): Estimated at USD 12,000/month considering discounts and rebates.
- Annual Cost per Patient: About USD 144,000.
Price Trends
- Historical Pricing: Stable since FDA approval, with minor fluctuations driven by competitive pressures and negotiations.
- Potential Price Changes: Not expected to decline significantly in the short term due to limited competition in the first-line ALK-positive NSCLC space.
Projected Market Penetration and Revenue
| Year |
Market Penetration |
Number of Patients (U.S.) |
Revenue (USD) |
Notes |
| 2023 |
65% |
1,430 |
1.72 billion |
Assumes steady growth and uptake |
| 2024 |
70% |
1,540 |
1.85 billion |
New approvals and expanded indications |
| 2025 |
75% |
1,650 |
2.00 billion |
Increasing market share |
Long-Term Price Projections (2026-2030)
- Stability: Prices are projected to remain steady barring significant patent challenges or emergence of generic competitors.
- Market Growth: Driven by increased global diagnosis, expanding indications, and adherence improvements.
- Regulatory Impact: Possible price adjustments due to changes in healthcare policy, particularly concerning drug pricing reforms.
Patent and Exclusivity Considerations
- Patent Expiry: Assumed to expire around 2027-2029, potentially enabling generic competition from 2028 onward.
- Market Exclusivity: Extended through data exclusivity until 2029 in the U.S., supporting premium pricing in the interim.
Strategic Implications
- The drug’s dominance in first-line ALK-positive NSCLC supports stable revenue streams.
- Competitive pressure from generics post-patent expiry could reduce prices by 20-40% over 3-5 years.
Summary of Key Data Points
- Market size (2022): USD 1.1 billion for ALK-positive NSCLC.
- Current price (U.S.): USD 14,000/month (USD 144,000/year).
- Projected revenue (2023): USD 1.72 billion across the U.S.
- Patent expiry: 2027-2029; generics expected 2028 onward.
- Market penetration: 70% in the U.S. among ALK inhibitors.
Key Takeaways
- The FDA-approved product Alecensa (NDC 66689-0694) holds a leading position in ALK-positive NSCLC.
- Market revenues will likely sustain above USD 1.5 billion annually in the U.S. through 2025.
- Pricing is expected to stabilize in the near term but decline after patent expiry due to generic competition.
- Expanding indications and global adoption may further increase revenue streams.
- Competitive positioning hinges on ongoing clinical superiority and pricing negotiations.
FAQs
Q1: When is patent expiry expected for Alecensa?
A1: Patent protections are expected to last until 2027-2029.
Q2: How does Alecensa's price compare internationally?
A2: International prices vary; generally lower in Europe and Asia due to price controls, with U.S. prices typically higher.
Q3: What factors could influence future price drops?
A3: Introduction of generics post-patent expiry, payer negotiations, and healthcare policy changes.
Q4: Are there upcoming clinical trials that could influence Alecensa’s market?
A4: Ongoing trials explore expansion into additional cancers and earlier lines of therapy, potentially affecting market size.
Q5: How is market share likely to evolve with new competitors?
A5: Dominance may decline post-patent expiry, with a potential 30-50% price reduction due to generic entries.
Sources
[1] IQVIA, 2022. Global Oncology Drug Market Data.
[2] U.S. Food and Drug Administration (FDA). Alecensa (Alectinib) Approval Documents.
[3] EvaluatePharma, 2022. Oncology Market Insights.
[4] Medicare & Medicaid Services (CMS). 2022 NDC Pricing Data.
