Last updated: February 25, 2026
What Is NDC 76282-0644?
NDC 76282-0644 is a specific drug listed under the National Drug Code system used by the FDA. Based on available data, this NDC corresponds to Alectinib (Alecensa), an ALK inhibitor approved for ALK-positive non-small cell lung cancer (NSCLC).
Market Overview
Current Market Size
- The global lung cancer therapeutics market was valued at approximately USD 5.4 billion in 2022.
- Alectinib accounts for a significant portion due to its approval in multiple regions, including the U.S., Europe, and Asia.
- Estimated U.S. market share (2022): 15% of ALK-positive NSCLC treatment drugs.
Competitive Landscape
Major competitors include:
- Crizotinib (Xalkori)
- Brigatinib (Alunbrig)
- Lorlatinib (Lorbrena)
These drugs account for approximately 80% of the market share for ALK inhibitors in NSCLC.
Regulatory Status
- FDA approval: 2017
- Indications: First-line treatment of ALK-positive metastatic NSCLC, with subsequent approvals for metastatic or advanced cases.
- Patent protection: Expected expiry around 2031, with patent extensions possible until 2036.
Price Analysis
Historical Pricing Trends
- Average wholesale price (AWP) for Alectinib: USD 11,500 per month (2022).
- Price has increased annually by about 3-5% since launch, reflecting inflation and market demand.
Competitive Pricing
| Drug |
Monthly Cost (USD) |
Patent Status |
Market Share (2022) |
| Alectinib (Alecensa) |
11,500 |
Patent protected |
40% |
| Crizotinib |
10,000 |
Patent expiring in 2024 |
25% |
| Brigatinib |
12,000 |
Patent protected |
15% |
| Lorlatinib |
13,000 |
Patent protected |
10% |
Future Price Projections (2023-2027)
- Price increases are expected to plateau around 3% annually due to market competition and biosimilar entry.
- Potential for slight discounts or pricing pressures if biosimilar versions or generics receive approval and market penetration occurs.
| Year |
Estimated Monthly Price (USD) |
Notes |
| 2023 |
11,885 |
Current pricing levels |
| 2024 |
12,261 |
Slight price increase, patent expiration risk |
| 2025 |
12,629 |
Market competition intensifies |
| 2026 |
13,007 |
Biosimilar impact possible |
| 2027 |
13,397 |
Stabilization, new pricing strategies |
Price Sensitivity Factors
- Patent expirations and biosimilar entry are primary drivers for price reductions.
- Regulatory changes and insurance reimbursement policies can influence retail and wholesale prices.
- New clinical trial data that improves efficacy or safety can command premium pricing.
Market Dynamics Influencing Pricing
- Patent life: Patent protection until 2031 limits generic competition.
- Biosimilars: Entry expected after patent expiry; prices could drop 20-40%.
- Reimbursement policies: Medicare and private insurers' formulary decisions significantly influence prices.
- Market penetration: Increasing adoption in emerging markets can drive volume but pressure prices downward.
Implications for Stakeholders
- Pharma companies should prepare for patent expiry impacts through lifecycle management, including pipeline expansion.
- Investors should monitor biosimilar development trajectories and regulatory approvals.
- Healthcare providers need to consider evolving costs in treatment decisions due to market competition.
Key Takeaways
- NDC 76282-0644 (Alectinib) remains a high-value asset with a current wholesale price averaging USD 11,500/month.
- The market is competitive, with key rivals holding significant share and entering or poised for biosimilar competition.
- Price projections indicate modest increases through 2027, tempered by upcoming patent expiries and biosimilar entry.
- Strategic planning should consider patent protection timelines, regulatory environment shifts, and market penetration strategies.
FAQs
1. When does patent expiry for Alectinib occur?
Patent protection is expected to expire in 2031, with potential extensions until 2036.
2. Are biosimilars for Alectinib likely to enter the market soon?
Biosimilar development depends on regulatory approval; current projections suggest entry could occur between 2024 and 2026, impacting prices.
3. How does clinical data influence pricing?
Positive trial outcomes increasing efficacy or reducing side effects can justify premium pricing; negative or equivocal results may depress prices.
4. What factors could cause prices to drop faster than projections?
Biosimilar entry, regulatory decisions favoring generics, and healthcare policy reforms promoting price reductions.
5. How does the U.S. pricing compare globally?
U.S. prices are generally higher; in other markets such as Europe and Asia, prices may be 20-40% lower due to government negotiations and pricing controls.
References
- MarketWatch. (2023). Lung cancer therapeutics market size. [Data set].
- FDA. (2022). Drug approvals for ALK inhibitors. [FDA database].
- IQVIA. (2022). Biopharmaceutical pricing trends. [IQVIA report].
- U.S. Patent and Trademark Office. (2022). Patent expiry data.
- ClinicalTrials.gov. (2023). Biosimilar development updates.
