Last updated: March 28, 2026
What is the drug associated with NDC 64764-0125?
NDC 64764-0125 corresponds to Sotorasib (LUMAKRAS), marketed by Amgen. It is approved for the treatment of non-small cell lung cancer (NSCLC) harboring the KRAS G12C mutation.
What is the current market landscape for Sotorasib?
Regulatory status and indications
- FDA approval: May 2021 for adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC.
- Expanded indications: Trials are ongoing for other cancers with KRAS G12C mutations, including colorectal cancer and pancreatic ductal adenocarcinoma.
Market size estimation
- Target population: KRAS G12C mutation occurs in roughly 13% of NSCLC cases.
- Estimated patient pool: 200,000 eligible patients in the U.S. (based on approximately 1.8 million NSCLC cases annually; 13% mutation rate).
- Market penetration: Assuming 25% penetration in year 1, rising to 50% by year 3.
Competitive landscape
- Key competitors: Adagrasib (Mirati), developed by Mirati Therapeutics, FDA-approved for similar indications.
- Pipeline drugs: Multiple investigational KRAS G12C inhibitors exist, including GDC-6036 and others.
Revenue projections
| Year |
Estimated Patients |
Market Penetration |
Patients Treated |
Price per Treatment |
Projected Revenue |
| 2023 |
200,000 |
25% |
50,000 |
$17,500 |
$875 million |
| 2024 |
200,000 |
35% |
70,000 |
$17,500 |
$1.225 billion |
| 2025 |
200,000 |
50% |
100,000 |
$17,500 |
$1.75 billion |
Note: The price estimate is based on the list price of approximately $17,000–$18,000 for a 28-day treatment course, reflecting premiums for targeted therapies.
Pricing dynamics
- List Price: Approx. $17,500 per month, translating to $210,000 annually per patient.
- Payer negotiations: Actual reimbursed rates are typically 70-80% of list price, possibly lowering revenue per patient.
Cost considerations
- Manufacturing costs: Estimated at 10-15% of list price.
- Pricing pressures: Increased competition from other KRAS G12C inhibitors might influence discounts.
Policy and reimbursement
- Medicare/Medicaid: Coverage is typically aligned with FDA approval; early access programs may influence initial uptake.
- Insurance trends: Favor reimbursement for targeted therapies with demonstrated survival benefits; ongoing cost-effectiveness assessments.
Risk factors impacting market share
- Patent expirations: Patent protection extends until approximately 2035, protecting market exclusivity.
- Pipeline developments: Newer competitors or additional indications could shift market dynamics.
- Pricing pressures: Payer negotiations and potential drug price regulation could restrict revenue growth.
Key takeaways
- The NSCLC market for KRAS G12C inhibitors is approximately $1.2–$1.75 billion annually in the U.S.
- Sotorasib holds a leading market position, with the potential to grow through expanded indications.
- Price points are high but subject to negotiation and competitive pressures.
- Revenue growth depends on market penetration, payer acceptance, and pipeline progress.
Frequently Asked Questions
1. How does Sotorasib compare to other KRAS G12C inhibitors?
Sotorasib was first to market, with a list price around $17,500/month. Competitors like Mirati’s adagrasib are similar in efficacy but may differ in pricing and approval status.
2. What factors could alter the market size for Sotorasib?
Emerging clinical trial data, new approvals for additional indications, or increases in competing therapies can influence patient numbers and drug adoption.
3. How do reimbursement policies impact revenue projections?
Payer negotiations can reduce effective reimbursement rates, impacting overall revenue, especially if discounts or formulary exclusions occur.
4. Is the market for KRAS inhibitors likely to expand beyond NSCLC?
Yes, ongoing trials for colorectal, pancreatic, and other cancers aim to broaden the therapeutic applications, further increasing the potential market.
5. What is the potential for biosimilars or generics?
Currently, Sotorasib’s patent protections prevent biosimilar entry until at least 2035, assuming patent extensions are not granted.
References
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U.S. Food and Drug Administration. (2021). FDA approves sotorasib for KRAS G12C-mutated metastatic non-small cell lung cancer. https://www.fda.gov
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Amgen. (2023). LUMAKRAS prescribing information. https://www.amgen.com
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MarketWatch. (2022). KRAS inhibitors market size and forecast. https://www.marketwatch.com
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Mirati Therapeutics. (2023). Adagrasib data and pipeline. https://www.mirati.com
