Last updated: March 13, 2026
What is NDC 68462-0625?
NDC 68462-0625 refers to a proprietary drug product approved by the FDA. Based on publicly available data, it is identified as Capmatinib (Tabwaltz), a targeted therapy for non-small cell lung cancer with MET exon 14 skipping alterations.
Market Overview
Indications and Usage
Capmatinib (Tabwaltz) was approved by the FDA in May 2020. It is indicated for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations, confirmed by an FDA-approved test. Its targeted mechanism positions it within the oncology niche, where personalized medicine has driven a significant increase in therapeutic options.
Market Size and Demand Drivers
- Estimated Global NSCLC Market: USD 8.2 billion in 2022, with a compound annual growth rate (CAGR) of 7.1% (Evaluate Pharma).
- MET Exon 14 Skipping Alters Prevalence: 3-4% of NSCLC cases, translating to approximately 30,000-40,000 patients in the U.S. annually.
- Current Treatment Paradigms: Dominated by chemotherapy, immunotherapy, and other targeted agents like capmatinib, tepotinib, and crizotinib.
Competitive Landscape
- Key Competitors: Tepotinib (Tecentriq), Crizotinib, Cabozantinib.
- Market Share (2022): Capmatinib holds approximately 12-15% of the targeted therapy segment for MET alterations.
Regulatory Status
- FDA Approval: May 2020.
- Other Approvals: Japan (2019), China (pending).
- Companion Diagnostics: FDA-approved test (FoundationOne CDx).
Price Analysis
Current Pricing Data
- Average Wholesale Price (AWP): Approximately USD 10,200 per month (per dose regimen).
- Per-Patient Annual Cost: Around USD 122,400, assuming continuous therapy.
- List Price Variations: Actual transaction prices are typically 20-30% below AWP due to discounts and rebates.
Pricing Benchmarks Compared to Similar Drugs
| Drug |
Indication |
Weekly Price |
Annual Cost |
Market Position |
| Capmatinib |
MET exon 14 skipping NSCLC |
USD 10,200/mo |
USD 122,400 |
First-in-class, has initial pricing premium due to orphan status |
| Tepotinib |
MET exon 14 skipping NSCLC |
USD 9,800/mo |
USD 117,600 |
Slightly lower; market competition influences pricing |
| Crizotinib |
ALK, ROS1-positive NSCLC |
USD 8,500/mo |
USD 102,000 |
Established, slightly lower due to longer market presence |
Price Trends and Projections
- 2023-2025 Trends: Slight downward pressure expected from payers and negotiations.
- Projected Discounting: 10-15% reduction in list prices due to increased market penetration.
- Future Price Adjustments: Could be influenced by the entry of generics or biosimilars, though none are currently in development for capmatinib.
Market Entry and Growth Potential
- Expansion into international markets remains a priority.
- Uptake driven by increasing diagnostic testing for MET alterations.
- Innovative combination therapies could influence demand and pricing strategies.
Summary
| Aspect |
Data/Prediction |
| Current Market Size |
USD 8.2 billion (global NSCLC) |
| Patient Access |
Approximately 30,000-40,000 eligible U.S. patients/year |
| Current Price |
USD 10,200/month (list), USD 122,400/year (per patient) |
| Price Trajectory |
Expected slight decline of 10-15% over next two years due to payer negotiations |
Key Takeaways
- NDC 68462-0625 (Capmatinib) commands a premium price within niche targeted therapies for NSCLC.
- The market focuses on MET exon 14 skipping alterations, with steady growth driven by diagnostic adoption.
- Price projections suggest gradual reductions aligned with market competition and payer strategies.
- Market expansion through international approvals remains critical for growth.
FAQs
1. What factors influence capmatinib's pricing?
Pricing is affected by market exclusivity, manufacturing costs, payer negotiations, and competitor pricing.
2. How does the market for MET inhibitors compare globally?
The U.S. has the largest market, followed by Europe and Japan, each with evolving diagnostic and reimbursement landscapes.
3. What is the potential for price reductions?
Rebates and negotiations could lower net prices by 10-15% over the next two years.
4. Are biosimilars or generics likely for capmatinib?
Current patents and market exclusivity delay biosimilar entry; no biosimilars are in development as of 2023.
5. How does diagnostic testing impact market growth?
Increasing testing adoption for MET alterations accelerates patient identification, boosting demand.
References
- Evaluate Pharma. (2022). Global oncology market data.
- FDA. (2020). Capmatinib (Tabwaltz) approval documents.
- IQVIA. (2022). U.S. pharmaceutical sales and pricing report.
- Pharmadeals. (2023). Oncology drug pricing and discounts analysis.
- GlobalData. (2023). International market approval landscape.
[Note: All prices and data are estimates based on publicly available sources and may vary with market conditions.]
