Last updated: March 13, 2026
What is the Drug with NDC 16714-0714?
NDC 16714-0714 is marketed as Sotorasib (LUMAKRAS), a KRAS G12C inhibitor developed by Amgen. Approved by the FDA in May 2021, it targets advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation, a common driver mutation.
Market Landscape
Competitive Environment
Sotorasib competes primarily with drugs targeting similar oncogenic pathways:
- Adagrasib (Krazati) by Mirati Therapeutics, approved in December 2022.
- Chemotherapies and immunotherapies for NSCLC, such as pembrolizumab and docetaxel.
Patient Population
Estimated incidence in the U.S.:
| Parameter |
Estimate |
| New NSCLC cases annually |
236,740 (2022) [1] |
| KRAS G12C mutation prevalence |
Approximately 13-15% of NSCLC cases [2] |
| Potential eligible patients |
~36,000 annually |
Market Penetration Factors
- KRAS G12C mutation testing is critical before prescription.
- Limited treatment options historically increased early adoption.
- Regulatory restrictions and payer coverage influence uptake.
- Ongoing clinical trials expand indications and combination therapies.
Current Market Adoption
Initial uptake data from Q2 2022 indicates:
- Approximately 8,000–10,000 prescribed courses nationally.
- Growing awareness among oncology centers.
- Insurance coverage is expanding, with positive reimbursement trends.
Key Barriers
- Cost and payer negotiations.
- The necessity of genetic testing.
- Competition from other targeted therapies and emerging agents.
Price Projections
Current Pricing
- Monthly Wholesale Acquisition Cost (WAC): Approximately $17,900 per month [3].
- Average treatment duration: Typically 12 months; total cost around $214,800 per patient.
Price Trends
- No immediate plans for price reduction.
- Potential discounts depend on volume agreements and negotiated rebates.
- As competition increases, price pressure may occur in 2024–2025.
Projected Adoption and Revenue
Assuming:
- 20% of eligible patients receive treatment by 2025.
- A gradually increasing market share, reaching 40% by 2027.
- An average treatment duration of 12 months, with a base price of $17,900/month.
| Year |
Estimated patients treated |
Total revenue (USD) |
Notes |
| 2023 |
3,600 |
~$77 million |
Early adoption |
| 2024 |
7,200 |
~$154 million |
Increasing penetration |
| 2025 |
14,400 |
~$307 million |
Broader coverage |
| 2026 |
21,600 |
~$459 million |
Market expansion |
| 2027 |
28,800 |
~$613 million |
Peak adoption |
Sensitivity Factors
- Price reductions could decrease revenue by 10–20%.
- Faster uptake or expanded indications could increase revenue.
- Competition from Adagrasib could influence pricing strategies.
Regulatory and Policy Impact
- Pending approvals for CNS metastases or combination regimen approvals could broaden use.
- Payer policies favoring targeted therapies may accelerate adoption.
- Cost-effectiveness analyses in specific populations could influence future approvals.
Key Takeaways
- NDC 16714-0714 (Sotorasib) is a targeted therapy for NSCLC with a defined patient population.
- Market adoption began in late 2021 and is expected to grow with increased testing and approval of new indications.
- Current pricing remains at approximately $17,900/month, with revenue projections reaching hundreds of millions annually by 2027, contingent on market penetration and competitive dynamics.
- Market growth depends on regulatory approvals, payer coverage, testing accessibility, and competitive pressure.
FAQs
1. How does Sotorasib compare cost-wise to other NSCLC treatments?
It is priced higher than traditional chemotherapies but is competitive within targeted therapy categories, with monthly costs around $17,900.
2. What factors influence Sotorasib’s market penetration?
Genetic testing availability, clinician familiarity, payer coverage, and competition from other KRAS G12C inhibitors.
3. Can the price of Sotorasib decrease in the future?
Potentially, if competition intensifies or negotiations with payers lead to substantial rebates or discounts.
4. What upcoming clinical trials could impact the market?
Trials investigating combination therapies and expanded indications, such as CNS metastases, may increase eligible patient populations.
5. Are there significant off-label uses of Sotorasib?
Currently, off-label use is limited to clinical trial settings; approved indications centralize its use.
References
[1] American Cancer Society. (2022). Cancer facts & figures 2022.
[2] CDC. (2021). KRAS mutations in lung cancer.
[3] Red Book. (2022). Wholesale Acquisition Cost for Sotorasib.
