Last updated: February 26, 2026
What is NDC 70000-0638?
NDC 70000-0638 is the National Drug Code for Tepmetko (tepotinib), developed by Melinta Therapeutics. Tepmetko is a kinase inhibitor approved for treating non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations.
Market Overview
Indication and Patient Population
Tepmetko addresses a niche within NSCLC, specifically MET exon 14 skipping mutation, present in approximately 3-4% of NSCLC cases. The overall global NSCLC incidence stands at around 2 million new cases annually, with roughly 60,000 to 80,000 patients potentially eligible for Tepmetko treatment globally (WHO, 2022).
Competitor Landscape
Key competitors include:
- Capmatinib (Tabrecta, Novartis)
- Tepotinib (Previously marketed as Tepmetko)
- Savolitinib (AstraZeneca, limited approval)
Market share projections depend on drug approval status, pricing, and reimbursement policies.
Regulatory Status
- U.S.: Approved by FDA on February 16, 2021.
- EU: Approved in March 2022.
- Japan: Approved in April 2022.
Market Penetration
Initial adoption depends on:
- Prescriber familiarity
- Reimbursement coverage
- Competitive pricing decision
Market entry strategies focus on specialty oncology centers, with targeted marketing toward molecular testing providers.
Pricing Analysis
Current Wholesale Acquisition Cost (WAC)
- Tepmetko's WAC in the U.S.: approximately $16,000 per month (per 240mg tablets) (5-month supply), equating to roughly $80,000 per year per patient.
International Price Variations
| Region |
Approximate Annual Cost |
Notes |
| U.S. |
$80,000 |
WAC, private insurers |
| EU |
€65,000 - €75,000 |
Varies by country, local policies |
| Japan |
¥8,000,000 (~$73,000) |
Reimbursement-linked |
| Canada |
CAD 106,000 (~$85,000) |
Reimbursement-adjusted |
Price Drivers
- Drug manufacturing cost estimated between $1,200 – $2,500 per patient annually.
- Patent exclusivity until at least 2035.
- Market competition from capmatinib influences pricing pressure.
Revenue and Sales Forecasts
Assumptions:
- Market penetration: 30% within eligible NSCLC patients over 5 years.
- US market share: 20% of total incident cases.
- Pricing stability: Maintain current WAC approximately at $80,000/year.
Estimated Revenue (US market, 2023-2028):
| Year |
Eligible Patients |
Market Penetration |
Patients Treated |
Annual Revenue |
Cumulative Revenue |
| 2023 |
20,000 |
10% |
2,000 |
$160 million |
$160 million |
| 2024 |
20,500 |
20% |
4,100 |
$328 million |
$488 million |
| 2025 |
21,000 |
30% |
6,300 |
$504 million |
$992 million |
| 2026 |
21,500 |
40% |
8,600 |
$688 million |
$1.68 billion |
| 2027 |
22,000 |
50% |
11,000 |
$880 million |
$2.56 billion |
Note: Changes in reimbursement policies or new entrants could alter revenue projections.
Key Factors Affecting Price and Market Dynamics
- Pricing pressures: Due to competition, especially from Capmatinib.
- Reimbursement policies: Variability in approvals influences market penetration.
- Patent life: Mercado could see generic entry post-2035, impacting pricing.
- Clinical guidelines: Incorporation into standard-of-care increases adoption.
Risks and Opportunities
- Risks: Limited patient population constrains revenue growth; high manufacturing costs versus price.
- Opportunities: Expansion into broader MET-altered cancers, combination therapies, geographic expansion.
Key Takeaways
- Tepmetko targets a narrow NSCLC niche, limiting large-scale revenue but commanding premium pricing.
- Current U.S. WAC centers around $80,000 annually per patient.
- Market penetration will depend on clinical adoption speed, reimbursement, and competition.
- Revenue estimates place potential at $160 million in early years, scaling to over $2 billion with aggressive adoption.
- Price competition and patent expiry pose long-term risks.
Frequently Asked Questions
1. How does Tepmetko compare price-wise to similar drugs?
It is priced similarly to other molecularly targeted NSCLC therapies like Capmatinib, with annual costs ranging from $75,000 to $85,000 in developed markets.
2. What are the main factors influencing Tepmetko’s pricing strategy?
Market exclusivity, manufacturing costs, competitive landscape, and reimbursement negotiations.
3. Can price projections improve with broader indications?
Yes. If Tepmetko proves efficacy in other MET-driven cancers or in combination therapy, demand and pricing could increase.
4. How does reimbursement impact market access?
Reimbursement policies vary, significantly affecting prescription rates and market share.
5. When does patent expiry threaten to erode pricing power?
Expected around 2035 unless patent extensions or formulations are obtained.
References
- World Health Organization. (2022). Global Cancer Statistics.
- U.S. Food and Drug Administration. (2021). Tepmetko approval notice.
- European Medicines Agency. (2022). Tepmetko approval summary.
- IQVIA. (2023). U.S. Prescription Drug Market Data.
- Manufacturer’s pricing disclosures.
