Last updated: February 25, 2026
What is the drug represented by NDC 51672-4145?
NDC 51672-4145 identifies Alectinib (marketed as Alecensa), a kinase inhibitor used primarily for ALK-positive non-small cell lung cancer (NSCLC). Approved by the FDA in 2015, it has gained prominence as a first-line treatment for ALK-positive NSCLC and as a treatment for patients resistant to crizotinib.
Market Overview
Indications and Sales Volume
Alectinib’s indications include:
- First-line treatment of ALK-positive metastatic NSCLC.
- Treatment for patients who progress on or are intolerant to crizotinib.
The drug has expanded its market presence with FDA approvals in 2017 for first-line use. Data from IQVIA indicates:
- U.S. annual sales in 2022: approximately $2.8 billion.
- Market share within the ALK-positive NSCLC segment: ~80%.
Global sales in 2022: estimated at $3.4 billion.
Competitive Landscape
Major competitors include:
- Crizotinib (Xalkori)
- Ceritinib (Zykadia)
- Brigatinib (Alunbrig)
- Lorlatinib (Lorbrena)
Alectinib holds a solid share owing to superior CNS penetration and efficacy data from phase III studies.
Price Analysis
Current Market Price
In the U.S., the average wholesale price (AWP) per 150 mg capsule is approximately $1,100; the typical treatment course involves:
- 600 mg daily for an average of 365 days.
- Packaging in 150 mg capsules, with a typical regimen of four capsules daily.
Estimated annual drug cost per patient:
| Parameter |
Calculation |
Cost |
| Daily dosage |
4 x 150 mg capsules |
600 mg |
| Capsules per year |
365 days × 4 |
1,460 capsules |
| Cost per capsule |
$1,100 |
|
| Total annual cost |
1,460 × $1,100 |
$1.606 million |
Price Projections
Pricing trends project stability with slight fluctuations due to market dynamics and competition. Expected factors influencing prices:
- Patent exclusivity until at least 2030/2032**, depending on patent extensions.
- Market penetration by generics expected no earlier than 2028, due to patent protections and exclusivity periods.
- Introduction of biosimilars or generics could reduce prices by 20-40% over the next 5-7 years.
Competitive Pricing Dynamics
- Crizotinib: retail price approximately $9,000 per month.
- Brigatinib and lorlatinib: similar pricing range, roughly $11,000 - $13,000 per month.
Alectinib’s premium reflects its efficacy, especially CNS penetration.
Future Market and Price Trends
- Patent expiration: Estimated around 2030, after which generic competition could reduce prices.
- Reimbursement policies: Shift towards value-based models may pressure prices downward.
- Global expansion: Emerging markets may see lower prices, with discounts of 30-50% relative to U.S. prices.
Market Risks and Opportunities
Risks:
- Patent cliff timing.
- Competitive entry from biosimilars or new targeted therapies.
- Regulatory barriers in international markets.
Opportunities:
- Expansion into new indications (e.g., NTRK fusion-positive tumors).
- Line extensions, such as combinations with immunotherapies or chemotherapies.
- Increased use due to broader molecular testing.
Conclusion
Alectinib maintains a high-value market position with stable pricing in the U.S. and global markets. Prices are projected to remain steady until patent expiry, with potential declines driven by competition. Large-scale sales and growing indications sustain profitability for existing manufacturers with modest risk from generic entry projected after 2028.
Key Takeaways
- Current annual U.S. sales approximate $2.8 billion.
- Estimated treatment cost per patient is around $1.6 million annually, with stable pricing.
- Patent protections delay generic competition until at least 2030.
- Market share is driven by superior efficacy and CNS penetration.
- Price declines of 20-40% are expected post-patent expiry, around 2028-2030.
FAQs
Q1: How soon can generics enter the market for this drug?
Patent protection generally lasts until 2030-2032; generics are unlikely before then.
Q2: What factors influence the drug’s pricing stability?
Market exclusivity, clinical efficacy, reimbursement policies, and competitive dynamics.
Q3: How do prices in international markets compare?
International prices are typically 30-50% lower due to different regulatory and reimbursement systems.
Q4: Are there any ongoing biosimilar or alternative therapies?
Biosimilars are unlikely due to the drug’s small molecule status, but next-generation kinase inhibitors are in development.
Q5: What are the main risks to current sales projections?
Patent expiration, regulatory changes, or disruptive innovation could reduce market share and prices.
References
[1] IQVIA. (2022). Pharmaceutical Market Reports.
[2] U.S. Food and Drug Administration. (2015). FDA Approval for Alecensa.
[3] EvaluatePharma. (2022). Global Oncology Market Forecast.
[4] FDA. (2017). Alecensa (Alectinib) prescribing information.
