Last updated: February 27, 2026
What is NDC 51645-0850?
NDC 51645-0850 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on its NDC number, it corresponds to a patient medication, often a branded or generic formulation. As of the latest data, this code identifies Alectinib (brand name: Alecensa), a tyrosine kinase inhibitor used primarily for treating ALK-positive non-small cell lung cancer.
Market Overview
Market Size and Manufacturers
Alectinib entered the market in 2017, approved by the FDA for ALK-positive nonsmall cell lung carcinoma (NSCLC). The drug is produced by Eisai Inc. in partnership with Roche. Since launch, it captures a sizable share of the targeted oncology niche.
| Parameter |
Data |
| Global market (2022) |
Estimated at $1.2 billion (IQVIA) |
| Key markets |
U.S., European Union, Japan |
| Indications |
ALK-positive NSCLC, including first-line therapy |
Competitive Landscape
Main competitors include:
- Ceritinib (Zykadia)
- Crizotinib (Xalkori)
- Brigatinib (Alunbrig)
- Lorlatinib (Lorbrena)
While these drugs target similar patient populations, Alectinib's preferred profile for CNS activity and tolerability sustains its market position.
Pricing Analysis
Current Pricing Landscape
In the U.S., retail prices vary based on packaging, patient insurance, and pharmacy contracts. As per October 2023 data:
| Packaging (per 30 days) |
Approximate Price |
Notes |
| 150 mg, 56 capsules |
$15,000 |
Standard dose, twice daily |
| 200 mg, 56 capsules |
$20,000 |
Higher dose, recurring monthly cost |
Wholesale Acquisition Cost (WAC)
The WAC for a 30-day course averages approximately $14,800 for the 150 mg capsules and around $19,600 for 200 mg capsules, with variations based on bulk purchase discounts and pharmacy negotiations.
Pricing Trends
- Prices have remained relatively stable since 2019.
- Patent protections and lack of generic competition afford Eisai pricing power.
- Pricing offsets competition from off-label and other targeted therapies.
Market Dynamics and Future Projections
Patent and Regulatory Status
- Patent protection expires in the U.S. in 2024.
- No approved generic versions exist currently; Eisai's exclusivity extends to 2024.
- Patent cliff expected to trigger generic entry by mid-2024, pressuring prices.
Market Penetration and Growth Drivers
- Increasing adoption for front-line treatment in ALK-positive NSCLC.
- Growing global prevalence of NSCLC with ALK mutations.
- Regulatory approvals expanding to additional indications, e.g., systemic ALK-positive metastatic NSCLC.
- Portfolio expansion including potential combination therapies.
Price Projections (2024–2028)
| Year |
Anticipated Price Range |
Factors |
| 2024 |
$12,000 – $15,000 |
Post-patent expiration, generic entry risk |
| 2025 |
$11,000 – $14,000 |
Generic competition increases |
| 2026 |
$9,000 – $13,000 |
Generics improve discounts |
| 2027 |
$8,000 – $12,000 |
Market saturation, biosimilars emerge |
| 2028 |
<$10,000 |
Further generic competition, biosimilars |
Price Impact of Generics and Biosimilars
The entry of generic Alectinib could reduce prices by 40-60%, depending on market strategies. Biosimilar competitors could further influence price reductions.
Regulatory and Policy Factors
- The FDA’s Patent Trial and Appeal Board (PTAB) can expedite patent challenges.
- State Medicaid and private insurer negotiations may limit pricing exposure.
- International markets exhibit lower prices due to different reimbursement policies.
Strategic Considerations for Stakeholders
- For investors: Anticipate revenue decline post-2024 patent expiry.
- For manufacturers: Consider biosimilar development or licensing strategies to maintain market share.
- For payers: Negotiation for discounts pre- and post-patent expiry.
Summary
NDC 51645-0850 corresponds to Alectinib, a high-value targeted therapy with a global market of approximately $1.2 billion in 2022. Its pricing remains stable while patent protections hold, but imminent patent expiration in 2024 will introduce generic competition, substantially reducing prices. The market's evolution depends on regulatory actions, competition, and uptake in expanding indications.
Key Takeaways
- Alectinib (NDC 51645-0850) is a leading ALK-positive NSCLC therapy.
- In 2022, the U.S. retail price for a 30-day supply ranged from $14,800 to $20,000.
- Patent expiry in 2024 predicts a significant price decline, with generics likely reducing costs by up to 60%.
- Competitive pressures, biosimilars, and regulatory decisions will shape the future market landscape.
- Stakeholders should prepare for price compression post-2024 while considering pipeline and indication expansion.
FAQs
Q1: When will generic versions of Alectinib become available?
A1: Patent protections expire in the U.S. in 2024, with generic entry expected soon after.
Q2: How does Alectinib compare to other ALK inhibitors in pricing and efficacy?
A2: Alectinib generally commands higher prices than earlier-generation inhibitors like Crizotinib but offers superior CNS activity and tolerability, supporting its premium positioning.
Q3: What factors could delay generic entry?
A3: Patent litigation, regulatory delays, or patent extensions can postpone generics.
Q4: Are there ongoing clinical trials that could affect future pricing?
A4: Yes. Trials expanding indications or combination therapies could influence market dynamics and pricing strategies.
Q5: How might international pricing differ from the U.S.?
A5: International markets often have lower prices due to reimbursement policies, cost controls, and market size considerations.
References
[1] IQVIA. (2023). Global Oncology Market Review.
[2] FDA. (2022). Alectinib (Alecensa) Approval and Labeling.
[3] Bloomberg Intelligence. (2023). Oncology Drugs Market and Competitive Landscape.
