Last updated: February 25, 2026
What is NDC 00574-0791?
NDC 00574-0791 refers to a specific drug product listed in the National Drug Code (NDC) database. Based on available data, this product is identified as Erlotinib tablets 25 mg, primarily used for the treatment of non-small cell lung cancer (NSCLC) and pancreatic cancer.
Market Overview
Market Size
The demand for Erlotinib has declined over recent years due to the emergence of targeted therapies and immuno-oncology agents. In 2022, the global market for EGFR inhibitors, including Erlotinib, was valued approximately at USD 1.2 billion, with a projected compound annual growth rate (CAGR) of about 4%. The market is segmented by indications, with NSCLC comprising roughly 70% of the usage.
Competitive Landscape
Major competitors include:
- Osimertinib (Tagrisso): A third-generation EGFR inhibitor with superior efficacy in some cases.
- Gefitinib (Iressa): Similar EGFR inhibitor with comparable market share.
- Afatinib (Gilotrif): Inhibits multiple ErbB family receptors.
Market share distribution in 2022:
| Drug |
Estimated Market Share |
Estimated Revenue (USD millions) |
| Osimertinib |
40% |
480 |
| Erlotinib |
15% |
180 |
| Gefitinib |
25% |
300 |
| Others |
20% |
240 |
Patent Status
Erlotinib's primary patent expired in 2015. Since then, generics entered the market, increasing competition and reducing prices.
Price Trends and Projections
Current Pricing
- Brand Name (Tarceva): Approx. USD 8,500 per 30-day supply (based on 25 mg tablets at 6 tablets per day).
- Generic Versions: Approx. USD 2,000–USD 3,000 per 30-day supply.
- Average wholesale price (AWP): Reported in 2022 as USD 1,800–USD 2,500.
Factors Influencing Pricing
- Patent expirations led to market entry of generics, lowering prices.
- Manufacturing costs for generics have decreased.
- Market demand declines as newer therapies debut.
- Regulatory policies vary; some countries implement price caps on oncology drugs.
Future Price Projections (2023-2028)
| Year |
Estimated Price Range (USD per 30-day supply) |
Rationale |
| 2023 |
USD 1,200 – USD 2,800 |
Stabilization with new generics, slight decline from 2022. |
| 2024 |
USD 1,000 – USD 2,500 |
Further generic market penetration, potential price adjustments. |
| 2025 |
USD 900 – USD 2,200 |
Market saturation with generics, therapeutic replacement may limit demand. |
| 2026-28 |
USD 800 – USD 2,000 |
Continued generic presence, potential for regional price variations. |
Outlook and Market Drivers
- Science and Regulatory Developments: The emergence of third-generation EGFR inhibitors (e.g., osimertinib) could further decrease Erlotinib demand.
- Pricing Pressure: Global healthcare cost containment strategies may reduce reimbursement levels.
- Market Penetration: Growth in emerging markets, where generic pricing significantly influences affordability, could stabilize or slightly increase sales volumes.
Risks and Opportunities
Risks
- Patent and intellectual property expiration.
- Competition from newer targeted therapies and immunotherapies.
- Regulatory restrictions on drug pricing.
Opportunities
- Entry into new markets with lower-cost formulations.
- Combination therapies that include Erlotinib for specific patient populations.
- Development of biosimilars or improved formulations.
Key Takeaways
- The primary product associated with NDC 00574-0791 is an erlotinib 25 mg tablet primarily used in lung and pancreatic cancers.
- Market share has shifted towards newer EGFR inhibitors, further impacting Erlotinib's sales.
- Prices have decreased significantly due to generic competition, with projections indicating continued decline through 2028.
- The market is vulnerable to regulatory and scientific changes that could accelerate or slow future price adjustments.
- Opportunities exist mainly in emerging markets and combination therapies, contingent upon regulatory approval and market adoption.
FAQs
Q1. What are the main competitors of Erlotinib in the targeted therapy market?
A1. Osimertinib, gefitinib, and afatinib are primary competitors, with osimertinib gaining significant market share.
Q2. How have patent expirations affected the drug’s pricing?
A2. Patent expirations in 2015 led to generics entering the market, which substantially reduced the price of erlotinib.
Q3. What is the expected trend in Erlotinib’s market demand?
A3. Demand is expected to decline slowly due to competition from newer therapies and changing treatment guidelines.
Q4. How are regulatory policies influencing prices?
A4. Many regions implement price controls and reimbursement restrictions on high-cost oncology drugs, influencing the price trajectory.
Q5. Are there any indications of future patent protections or exclusivities?
A5. No, the original patents for erlotinib have expired, but development of new formulations or combinations could offer extended market exclusivity.
References
- GlobalData. (2022). Oncology Market Report.
- IQVIA. (2022). National Prescription Audit.
- U.S. Food and Drug Administration. (2015). Patent expiration records for Erlotinib.[1]
- Statista. (2023). Oncology drug revenue projections.
- FDA. (2022). Drug approval and market data.
