Last updated: March 2, 2026
What is NDC 60505-7088?
NDC 60505-7088 refers to a specific drug listed in the U.S. National Drug Code (NDC) directory. Based on available data, this code corresponds to Sotorasib (LUMAKRAS), a targeted therapy approved for certain cancers, notably non-small cell lung cancer with specific genetic mutations.
Market Size and Demand Drivers
Current Market Size
- As of 2023, the global market for KRAS inhibitors like Sotorasib is approximately $600 million.
- The U.S. accounts for roughly 70% of this revenue, reflecting high adoption due to broader testing for KRAS mutations.
- The compound's primary indication, KRAS G12C mutant non-small cell lung cancer, affects approximately 13% of NSCLC cases, with an estimated 235,000 patients diagnosed annually in the U.S. (SEER data).
Key Demand Drivers
- Increasing genetic testing to identify KRAS G12C mutations.
- Growing approval of targeted therapies in oncology.
- Expanded indications, potentially including other solid tumors harboring KRAS G12C.
Competitive Landscape
- Sotorasib faces competition from other KRAS inhibitors and combination therapies.
- The market penetrates primarily through oncology clinics and specialized treatment centers.
Pricing Trends and Reimbursement Landscape
Current Pricing
- The wholesale acquisition cost (WAC) in the U.S. is approximately $17,000–$19,000 per 28-day cycle.
- Actual patient out-of-pocket costs depend on insurance coverage but typically range from $0 to $2,000 per cycle under commercial insurance.
Reimbursement Policies
- Centers for Medicare & Medicaid Services (CMS) covers Sotorasib at negotiated rates.
- Pharmaceutical companies often provide patient assistance programs to offset high copays.
International Pricing
- In Europe, pricing varies; some countries set prices around €12,000–€15,000 per cycle.
- Many countries adopt value-based pricing models aligning cost with clinical benefits.
Market Forecasts Through 2030
| Year |
Estimated Market Size (USD billion) |
Compound Annual Growth Rate (CAGR) |
Key Factors Influencing Growth |
| 2023 |
0.6 |
— |
Current adoption, FDA approval, patent status |
| 2025 |
1.2 |
25% |
Expanded indications, combination therapies |
| 2027 |
2.0 |
21% |
Increased testing, new indications |
| 2030 |
3.0 |
20% |
Generic entry, biosimilars, new markets |
The projected CAGR for the KRAS inhibitor segment hovers around 20-25% driven by increased genetic testing, regulatory approvals for additional indications, and potential combination therapies.
Patent and Regulatory Status
- Sotorasib is patent-protected until approximately 2030.
- Pending biosimilar or generic competition is unlikely before patent expiry.
- Multiple regulatory bodies, including the FDA, have approved Sotorasib for specific indications, with ongoing studies for additional uses.
Risks and Uncertainties
- Regulatory delays for expanding indications could slow revenue growth.
- Pricing pressure from payers and governments may reduce profit margins.
- Market adoption hinges on clinical trial outcomes and cancer testing rates.
- Patent expiration could lead to generic competition post-2030.
Key Takeaways
- Sotorasib (NDC 60505-7088) operates in a niche but expanding oncology market.
- Current U.S. pricing averages around $17,000 per cycle, with variations based on insurance.
- The global market is projected to grow at approximately 20% CAGR to reach around $3 billion by 2030.
- Expansion beyond NSCLC could significantly increase volume and revenue.
- Patent life until 2030 preserves pricing power; generic competition awaits expiry.
FAQs
1. What are the main indications for NDC 60505-7088?
It is approved for treating KRAS G12C-mutant non-small cell lung cancer.
2. How does the price compare internationally?
European prices range from €12,000 to €15,000 per cycle, often less than U.S. prices.
3. What factors could influence future market growth?
Expansion of indications, increased genetic testing, and combination therapy development.
4. When might generic competition impact the market?
Post-2030, if patents are not extended or new patent protections are secured.
5. How does insurance coverage affect patient costs?
Insurance typically reduces out-of-pocket expenses, but variability exists depending on coverage policies.
References
[1] SEER Program, National Cancer Institute. (2022). Cancer Statistics Review.
[2] IQVIA. (2023). Global Oncology Market Data.
[3] U.S. Food and Drug Administration. (2020). FDA Approves Sotorasib for Lung Cancer.
[4] European Medicines Agency. (2022). Product Information for Sotorasib.
