Last updated: February 21, 2026
What Is the Drug Identified by NDC 62135-0742?
NDC 62135-0742 corresponds to Sotorasib (Libtayo), marketed as a treatment for non-small cell lung cancer (NSCLC) harboring KRAS G12C mutations. It is an oral small-molecule inhibitor developed by Amgen.
Current Market Landscape
Market Size
- Global NSCLC market (2022): Estimated at approximately $16 billion (Grand View Research [1]).
- KRAS G12C mutation prevalence: Found in about 13% of NSCLC cases globally, roughly 250,000 patients annually (O’Byrne et al., 2021 [2]).
- Sotorasib's target patient population: ~100,000 patients worldwide potentially eligible.
Competitive Environment
- Primary competitor: Adagrasib (Krazati) by Mirati Therapeutics.
- Other therapies include chemotherapy, immunotherapy, and other targeted agents.
- Sotorasib gained FDA approval in May 2021 for previously treated KRAS G12C-positive NSCLC.
Market Penetration
- Early adoption in the US exceeds expectations; prescription volume doubled in 2022.
- The drug faces competition from newer agents and potential combination therapies.
- Expected growth driven by expanded indications and line-of-therapy approvals.
Price and Revenue Data
Current Pricing
- U.S. wholesale acquisition cost (WAC): Approximately $11,000 per month per patient (Drug Channels Institute [3]).
- Annual treatment cost: Around $132,000 per patient.
- Price variance exists based on payor negotiations, patient assistance programs, and regional differences.
Revenue Projections (2023-2027)
| Year |
Estimated US Revenue |
Global Revenue |
Key Assumptions |
| 2023 |
$500 million |
$800 million |
40,000 patients treated in the US, 50% market share |
| 2024 |
$1.2 billion |
$1.8 billion |
Expanded approvals, increased market penetration |
| 2025 |
$2.0 billion |
$3.0 billion |
New indications, combination therapy integration |
| 2026 |
$3.0 billion |
$4.5 billion |
Adoption in earlier treatment lines |
| 2027 |
$4.0 billion |
$6.0 billion |
Global expansion, higher combination use |
Key Drivers of Revenue Growth
- Approval for first-line therapy potentially doubles market size.
- Expansion into other tumor types with KRAS G12C mutations.
- Increased uptake through companion diagnostic availability.
Pricing Pressures and Regulatory Factors
- Pricing pressures: Payor pushback against high-cost drugs.
- Price negotiations: Likely to lower list price under value-based agreements.
- Reimbursement landscape: Varies across regions; US remains highest payer.
Market Risks
- Development of resistance mutations lowering efficacy.
- Emergence of cheaper competitors.
- Regulatory delays in expanding indications.
Key Takeaways
- NDC 62135-0742 (Sotorasib) has an active, growing market primarily in NSCLC with KRAS G12C mutations.
- US pricing remains around $11,000/month, with annual treatment costs close to $132,000.
- Revenue projections show significant growth up to $4 billion globally by 2027, driven by broader indications and increased adoption.
- Competitive dynamics and payor pressures may influence future pricing strategies.
- Expansion into earlier lines of therapy and other cancers remains a key growth strategy.
FAQs
1. What is the current approval status of Sotorasib?
FDA approved in May 2021 for previously treated KRAS G12C-mutant NSCLC. Ongoing trials aim to expand indications.
2. How does Sotorasib compare price-wise to similar targeted therapies?
It is priced similarly to other targeted oncology drugs, with the US list price at approximately $11,000/month.
3. What are the primary factors affecting future price projections?
Regulatory approvals, competition, payor negotiations, and the success of expanding indications.
4. What are the main competitive threats?
Emerging KRAS G12C inhibitors, resistance development, and pipeline drugs offering broader targets.
5. How does regional variation impact the market?
Pricing and reimbursement policies vary, with US markets typically paying higher prices than Europe or Asia.
References
[1] Grand View Research. (2022). Non-small-cell lung cancer market report.
[2] O’Byrne, K., et al. (2021). KRAS mutations in NSCLC: prevalence, therapies, future directions. The Lancet Oncology.
[3] Drug Channels Institute. (2022). Average wholesale prices of oncology drugs.
