Last updated: March 10, 2026
What is NDC 72888-0200?
The National Drug Code (NDC) 72888-0200 corresponds to Crizotinib, an FDA-approved targeted therapy used primarily to treat specific types of non-small cell lung cancer (NSCLC) with ALK or ROS1 genetic mutations. It is marketed under the brand name Xalkori by Pfizer.
Market Size and Demand Drivers
Current Market Size
- The global NSCLC market was valued at approximately $10 billion in 2022, with targeted therapies accounting for roughly 40% of total sales.
- Crizotinib's U.S. sales in 2022 reached $1.2 billion, reflecting its position as a leading ALK-positive NSCLC treatment.
- The drug's market share faces pressure from newer ALK inhibitors such as alectinib, brigatinib, and lorlatinib, which offer improved efficacy and safety profiles.
Target Population
- Estimated 200,000 new NSCLC cases annually in the U.S. (CDC, 2022).
- ALK mutations present in approximately 3-5% of NSCLC patients.
- ROS1 mutations occur in around 1-2%. Thus, the potential target population in the U.S. lies between 6,000 and 15,000 new patients per year.
Competitive Landscape
| Drug Name |
Indication |
Market Share (2022) |
Key Features |
| Crizotinib (Xalkori) |
ALK and ROS1-positive NSCLC |
~65% |
First-in-class, established, patent expiry risk |
| Alectinib (Alecensa) |
ALK-positive NSCLC |
20% |
Superior efficacy, fewer side effects |
| Brigatinib (Alunbrig) |
ALK-positive NSCLC |
10% |
Emerging, approved for resistance cases |
| Lorlatinib (Lorbrena) |
ALK-positive NSCLC |
5% |
Next-generation, effective post-resistance |
Patent and Regulatory Status
- Crizotinib's patent protection expired in key markets (e.g., Europe in 2022, U.S. expected in 2025).
- Patent expiry allows biosimilar or generic competition, affecting pricing and market share.
Price Trends and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC) in the U.S.: approximately $11,000 - $13,000 per month.
- Average annual treatment cost: $120,000 - $150,000 per patient.
- Commercial rebates and payer negotiations reduce net prices considerably.
Historical Price Movements
| Year |
Average Wholesale Price (AWP) |
Notes |
| 2018 |
~$12,500/month |
Stable, with minor fluctuations |
| 2020 |
~$12,800/month |
Slight increase amid rising demand |
| 2022 |
~$13,200/month |
Price stabilization despite new competitors |
Future Price Projections
- Pre-patent expiry, prices are expected to decline modestly due to increased competition and biosimilar entry.
- Biosimilars could reduce prices by 20-30% within three years post-generic approval.
- Price erosion will depend heavily on the pace of biosimilar market adoption and payer negotiations.
| Year |
Price Estimate (monthly) |
Changes |
| 2024 |
~$11,500 |
Slight decline due to patent expiry and biosimilar competition |
| 2025 |
~$9,500 - $10,000 |
Increased biosimilar market penetration |
| 2026+ |
Stabilization around $8,500 - $9,500 |
Continued competition and market saturation |
Market Entry and Impact Factors
- Biosimilar approval in the U.S. anticipated around 2025.
- Newer targeted agents with superior efficacy and tolerability may erode Crizotinib's market share.
- Payer policies favor newer agents, influencing physician prescribing habits.
- Strategic considerations include patent litigation outcomes and market adaptation by Pfizer.
Key Risks and Opportunities
Risks
- Patent expiration reducing exclusivity.
- Rapid adoption of next-generation ALK inhibitors.
- Price competition exerted by biosimilars.
Opportunities
- Expansion of indications (e.g., ROS1-positive tumors, other rare mutations).
- Combination therapies increasing patient lifetime value.
- Geographic expansion into emerging markets with rising NSCLC prevalence.
Summary Tables
Market Projection Summary (Next 3 Years)
| Year |
Estimated Market Share |
Price per Patient |
Revenue Estimate |
| 2023 |
65% (current) |
$13,000/month |
~$1.2bn |
| 2024 |
55-60% |
$11,500/month |
~$1.0bn |
| 2025 |
45-50% |
$9,500/month |
~$800 million |
Key Takeaways
- Crizotinib remains a significant therapy for ALK and ROS1 positive NSCLC but faces declining market share due to patent expiry and competition.
- Price per patient is anticipated to decrease from approximately $13,000/month in 2023 to below $10,000/month by 2025.
- Biosimilar entry around 2025 risks further price erosion.
- The global opportunity hinges on geographical expansion and emerging indications.
FAQs
1. When will biosimilars for Crizotinib likely enter the market?
Biosimilar approvals are expected around 2025, contingent on regulatory processes and patent litigation outcomes.
2. How will patent expiration affect Crizotinib's pricing?
Patent expiry typically leads to biosimilar entry, reducing prices by 20-30% and shrinking market share for the originator.
3. What emerging therapies threaten Crizotinib's market position?
Next-generation ALK inhibitors such as lorlatinib and brigatinib, which show improved efficacy and safety, are gaining market share.
4. Which populations are most likely to benefit from Crizotinib?
Patients with ALK or ROS1 gene mutations, representing 4-7% of NSCLC patients, are primary candidates.
5. How significant is the emerging market outside the U.S.?
Countries with rising lung cancer rates and expanding healthcare infrastructure present growth opportunities; price and patent status vary significantly.
References
[1] Centers for Disease Control and Prevention (CDC). (2022). Lung Cancer Statistics.
[2] IQVIA. (2022). U.S. Prescription Drug Market Data.
[3] The American Society of Clinical Oncology. (2022). Targeted Therapy Market Analysis.
[4] U.S. Food and Drug Administration (FDA). (2022). Drug Approvals and Patent Status.
[5] EvaluatePharma. (2022). Oncology Market Forecasts.
