Last updated: February 27, 2026
What is NDC 70677-1085?
NDC 70677-1085 is a drug marketed under the name Crizotinib. It is used primarily in targeted cancer therapy, specifically for ALK-positive non-small cell lung cancer (NSCLC). The drug is marketed by Pfizer under the brand name Xalkori.
Current Market Landscape
Market Size and Patient Population
- Global NSCLC Market: Valued at approximately $10.5 billion in 2022, with targeted therapies like Crizotinib comprising a significant share.
- ALK-Positive Subset: Accounts for roughly 3-5% of NSCLC cases globally. Estimated to represent 150,000–200,000 patients worldwide annually.
- U.S. Market Penetration: About 80,000 patients diagnosed annually; roughly 4,000–10,000 are ALK-positive, depending on testing rates and demographic shifts.
Competitive Landscape
- Key Competitors: Alectinib (Alecensa), Brigatinib (Alunbrig), Lorlatinib (Lorbrena), and newer agents like Entrectinib.
- Market Share: Crizotinib holds approximately 40–50% of the ALK-positive NSCLC segment, with the remainder split among competitors.
Regulatory Status & Approvals
- US: FDA approved since 2011 for ALK-positive NSCLC.
- Europe: EMA approved since 2012.
- Additional Indications: ROS1-positive NSCLC; ongoing studies for other solid tumors.
Price Analysis
Current Pricing
- Average Wholesale Price (AWP): ~$13,000 per month per patient.
- Average Selling Price (ASP): Approximately $11,500—$12,000 per month.
- Annual per-patient cost: ~$138,000–$144,000.
Reimbursement Landscape
- Majority covered by insurance including Medicare and Medicaid.
- Patient out-of-pocket costs vary but typically range from $100 to $500 monthly due to co-pays and assistance programs.
Price Trends and Projections
Recent Price Movements
- Stable in recent years: Price increases have been limited to 2–3% annually over the last five years.
- Biosimilar/Generic Entry: No biosimilars or generics yet, maintaining high barriers to price reduction.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price Range (Monthly) |
Key Assumptions |
| 2023 |
$12,800 – $13,200 |
Inflation-neutral pricing with no biosimilar impact |
| 2024 |
$12,900 – $13,300 |
Market stabilization; R&D costs potentially influencing |
| 2025 |
$13,000 – $13,500 |
Introduction of competing therapies may limit upward movement |
| 2026 |
$13,000 – $13,600 |
Price maintenance due to steady demand and patent exclusivity |
| 2027 |
$13,000 – $13,700 |
No biosimilars; potential reforms may influence prices |
Impact Factors
- Patent protection: Extended until at least 2028, preventing generics.
- Therapeutic advancements: Development of next-gen inhibitors could threaten pricing.
- Market dynamics: Increased testing and diagnosis rates could expand the market, possibly influencing pricing strategies.
- Reimbursement policies: Price controls or negotiation powers (particularly in Europe) could limit increases.
Key Considerations for Stakeholders
- Pharmaceutical companies need to watch patent expiry timelines and biosimilar development.
- Investors should monitor R&D pipelines for next-generation therapies and market share shifts.
- Healthcare payers are likely to seek discounts and formulary restrictions as competition increases.
Summary
NDC 70677-1085 (Crizotinib) remains a high-cost therapy with stable pricing driven by patent exclusivity and limited competition. The U.S. market’s inflationary pressures are minimal over the next five years, with prices primarily influenced by technological advances and regulatory decisions. Entry of biosimilars remains unlikely before 2028, supporting sustained revenue streams.
Key Takeaways
- Crizotinib's annual treatment cost remains steady at approximately $138,000–$144,000.
- Market share remains dominant in ALK-positive NSCLC, with limited immediate competition.
- Price increases are constrained by patent protections and therapeutic alternatives.
- Biosimilar entry and generics anticipated post-2028 could reduce prices.
- Reimbursement policies and market dynamics will influence long-term pricing trajectories.
FAQs
1. When does Crizotinib face generic or biosimilar competition?
Patent expiry is expected around 2028, after which biosimilars or generics may enter the market.
2. How does the current price compare to other targeted NSCLC therapies?
Crizotinib’s monthly cost (~$12,800–$13,200) is comparable or slightly higher than newer agents like Lorlatinib but less than some combination therapies.
3. Will prices increase significantly in the next five years?
No, price increases are projected to stay within a 3% annual range, constrained by market maturity and regulatory factors.
4. How does reimbursement impact the actual cost to patients?
Most patients pay between $100 and $500 monthly after insurance, though high deductibles and co-pays can vary.
5. What factors could significantly alter the price trajectory?
Introduction of biosimilars, regulatory price controls, or major patent litigation could impact prices.
References
- IQVIA. (2022). Global Oncology Market Forecast.
- FDA. (2011). Approval of Crizotinib. https://www.fda.gov/drugs/resources-information-approved-drugs/crizotinib
- evaluatepharma. (2022). Oncology Drug Market Data.
- Medicare.gov. (2022). Part D drug pricing information.
