Last updated: February 23, 2026
What is NDC 72888-0064?
NDC 72888-0064 identifies Xalkori (crizotinib) tablet 250 mg, manufactured by Pfizer. It is approved for the treatment of ALK-positive and ROS1-positive non-small cell lung cancer (NSCLC).
Market Overview
Indication and Patient Population
Xalkori targets a subset of NSCLC patients with specific genetic mutations. Estimates suggest approximately 3-5% of lung cancers are ALK-positive, equating to an estimated 30,000–50,000 patients in the U.S. annually.
Market Size and Trends
- Global lung cancer market (2022): valued at ~$14 billion, expected to grow at a CAGR of 5% through 2030.
- Xalkori's share: accounted for approximately $850 million in U.S. sales in 2022.
- Market penetration: increasing due to expanded genetic testing and approval for late-line indications.
Competitors
- Alectinib (Alecensa): second-line, at roughly 25% market share.
- Ceritinib (Zykadia): third-line, decreasing due to competition.
- Lorlatinib (Lorbrena): newer and gaining market share.
Regulatory Actions and Impact
- FDA approvals: Clearance for targeted treatments boosts prescribing rates.
- Label updates: inclusion of combo regimens and expanded indications can impact sales.
Price Trends and Projections
Current Pricing
- Average Wholesale Price (AWP): approximately $12.50 per tablet.
- Average Selling Price (ASP): around $10 per tablet.
- Per-treatment course cost: approximately $62,500 (250 mg twice daily for 12 months).
Historical Price Changes
- Since FDA approval in 2011, prices have remained relatively stable.
- Several payers have negotiated discounts, reducing net prices by 15-20% relative to AWP.
- No major price reductions linked to biosimilars or generics because no biosimilar has been approved for crizotinib.
Future Price Projections (Next 5 Years)
| Year |
Estimated Average Price (per tablet) |
Notes |
| 2023 |
$10.00 |
Current ASP. Slight downward pressure expected due to payer negotiations. |
| 2024 |
$9.80 |
Minimal decline driven by contract discounts. |
| 2025 |
$9.50 |
Market stabilization; potential minor reductions. |
| 2026 |
$9.20 |
Slight decrease with shift toward value-based pricing. |
| 2027 |
$8.90 |
Continued compression amid evolving reimbursement policies. |
Revenue Projections
| Year |
U.S. Sales |
Global Sales |
Comments |
| 2023 |
$850 million |
$1.2 billion |
Steady demand, market penetration plateau. |
| 2024 |
$860 million |
$1.3 billion |
Growth driven by expanded indications. |
| 2025 |
$870 million |
$1.4 billion |
Slight uptick with increased testing. |
| 2026 |
$880 million |
$1.5 billion |
Market saturation approaching. |
| 2027 |
$890 million |
$1.6 billion |
Potential new pricing strategies or indicaitons. |
Regulatory and Market Risks
- Biosimilar or generic entry: None currently approved but could erode pricing.
- Competing therapies: New targeted agents or immunotherapies could impact market share.
- Off-label use and reimbursement: Could alter demand patterns unpredictably.
Key Takeaways
- NDC 72888-0064 corresponds to Xalkori, with a stable sales history since market launch.
- The drug serves a niche market within NSCLC, with ongoing growth prospects driven by genetic testing and expanding indications.
- Price projections forecast slight declines in ASP over the next five years, aligning with market stabilization and payor negotiations.
- The revenue outlook remains positive, dependent on continued market penetration and competitive landscape dynamics.
- Risks include regulatory changes, biosimilar entry, and new therapeutic competitors.
FAQs
What factors influence Xalkori's pricing?
Pricing is affected by payer negotiations, market competition, label expansions, and manufacturing costs.
Are biosimilars or generics expected for crizotinib?
No approved biosimilars or generics exist yet. Expectation remains low for the next 2-3 years due to patent protections and complexity in biosimilar development.
How does genetic testing impact the market?
Enhanced testing increases detection of ALK-positive NSCLC, expanding the eligible patient population and supporting sales growth.
What are the competitive threats to Xalkori?
Emerging therapies such as lorlatinib and other targeted agents, as well as immune checkpoint inhibitors, could capture market share.
What are the primary regulatory considerations?
Label expansions, new indications, or approval of biosimilars could influence pricing and market dynamics.
References
[1] IQVIA. (2022). Pharmaceutical Market Data.
[2] FDA. (2022). Drug Approvals and Labeling.
[3] EvaluatePharma. (2022). World Preview 2022, Outlook to 2027.
