Last updated: February 16, 2026
Overview of NDC 75907-0050
NDC 75907-0050 refers to Sotorasib (brand name Lumakras), a KRAS G12C inhibitor approved by the FDA in May 2021 for treating KRAS G12C-mutated non-small cell lung cancer (NSCLC). It is a targeted therapy designed for patients with specific genetic mutations.
Market Size and Demand Dynamics
Global and U.S. Oncology Market Context
- The non-small cell lung cancer (NSCLC) segment accounts for approximately 85% of lung cancers globally.
- U.S. NSCLC incidence: 225,000 new cases annually (2022 data).
- KRAS G12C mutation prevalence in NSCLC: roughly 13%, estimating 29,250 potential U.S. patients annually in need of targeted therapy.
Competitive Landscape
- Sotorasib faces competition from emerging KRAS G12C inhibitors, notably Amgen’s AMG 510 (Lumakras), which has similar indications.
- Several pipeline drugs target KRAS mutations, but Sotorasib maintains first-mover advantage in this niche due to earlier FDA approval.
Market Penetration and Adoption
- Initial adoption rates are cautious due to cost, physician familiarity, and side effects.
- Post-launch data shows rapid uptake, with estimates of 10,000–15,000 patients in the U.S. receiving Sotorasib annually within five years.
- Broader indications are under clinical evaluation, including combination therapy in wider NSCLC populations.
Pricing and Revenue Projections
Current Pricing Overview
- Wholesale Acquisition Cost (WAC): approximately $11,000 per month.
- Cost per year: roughly $132,000.
Pricing considerations:
- Price set to reflect targeted therapy value, manufacturing costs, and competitive landscape.
- Discounting, rebates, or insurance negotiations could reduce net prices.
Revenue Potential
| Year |
U.S. Market Revenue Estimate |
Notes |
| 2023 |
$1.2 billion |
Based on 10,000 annual patients, at $132,000/year, adjusted for initial launch phase. |
| 2024 |
$1.8 billion |
Growing patient base, increased physician awareness, new approvals. |
| 2025 |
$2.3 billion |
Further expansion, potential inclusion in combination regimens. |
- Excluding international markets, which could add another $500 million to $1 billion annually.
Long-Term Price & Market Trends
- Price erosion expected starting year 3 due to generic or biosimilar entrants, though this risk is moderate given the drug's exclusivity and ongoing patent protections.
- Evolving combination therapies may influence demand, potentially increasing overall market size but diluting individual drug market share.
Regulatory and Policy Impact
- Medicare and private insurers' reimbursement policies impact access and pricing.
- Recent CMS policies aim to promote value-based pricing; initial negotiations could pressure net prices downward.
Key Market Drivers
- Unmet need in KRAS G12C mutations.
- Demonstrated efficacy in combatting specific NSCLC subpopulations.
- Growing biomarker-driven treatment paradigm.
- FDA approvals expanding indications in solid tumors.
Challenges & Risks
- Competitive drugs entering the market.
- Price reductions due to negotiations and biosimilars.
- Resistance development reducing long-term patient numbers.
- Regulatory changes impacting reimbursement strategies.
Key Takeaways
- NDC 75907-0050 (Sotorasib) has a target market of approximately 29,000 U.S. NSCLC patients annually with KRAS G12C mutations.
- Current pricing at ~$132,000 per year delivers expected U.S. revenue of roughly $1 billion in 2023, with growth potential.
- Market growth depends on broader adoption, expansion of indications, and overcoming competition.
- Price erosion may occur within three to five years, impacted by biosimilar entry and policy changes.
- International markets could significantly augment total revenue, adding up to $1 billion annually.
FAQs
1. What is the primary indication for NDC 75907-0050?
Treatment of KRAS G12C-mutated non-small cell lung cancer in adult patients.
2. What is the estimated annual U.S. patient population?
Approximately 29,000 patients, based on NSCLC incidence and mutation prevalence.
3. What is the current wholesale price of the drug?
About $11,000 per month, or $132,000 annually.
4. What are the main market competitors?
Amgen’s AMG 510 (Lumakras), with ongoing development of additional KRAS inhibitors and combination therapies.
5. What factors could influence future pricing?
Market competition, biosimilar entry, regulatory policies, and adoption rates.
References
- American Cancer Society. "Key Statistics for Lung Cancer." 2022.
- U.S. Food and Drug Administration. “FDA approves first targeted therapy for KRAS G12C-mutated non-small cell lung cancer.” May 28, 2021.
- IQVIA. "Pharmaceutical Pricing Trends." 2022.
- Centers for Medicare & Medicaid Services. "National Coverage Determinations." 2021.
- Company reports and press releases on Lumakras launches and sales projections.
