Understanding the NDC System
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand the NDC system. The NDC is a unique, three-segment number that serves as the FDA’s identifier for drugs. It includes the labeler code, product code, and package code, providing detailed information about the drug product, its manufacturer, and packaging[1][4].
Identifying the Drug
The NDC 82584-0003 corresponds to a specific drug product. However, without specific details from the FDA's National Drug Code Directory or other databases, we cannot directly identify the drug name, its therapeutic class, or its current market status from the provided sources.
Market Analysis
General Market Trends
To conduct a market analysis, we need to consider broader trends in the pharmaceutical industry. Here are some key points:
- Price Increases: The pharmaceutical industry has seen significant price increases in recent years. For instance, the median price increase for brand name drugs was 13.4% in 2022, while generic drugs saw a median price increase of 19.9%[2][5].
- Market Segments: Different therapeutic areas have varying growth rates. For example, the Non-Small Cell Lung Cancer (NSCLC) market is projected to grow significantly, driven by the adoption of immunotherapies and targeted therapies. By 2025, the NSCLC market is expected to reach $26.8 billion, with immunotherapies accounting for a substantial portion of this growth[3].
Specific Drug Market
Without the specific drug name associated with NDC 82584-0003, we can only speculate based on general trends:
- Therapeutic Class: If the drug falls under a high-growth therapeutic class like oncology, it may benefit from the overall market expansion. For example, drugs like Keytruda, Opdivo, and Tecentriq in the NSCLC market are projected to achieve blockbuster status by 2025[3].
- Competition: The presence of competitors, including generics and biosimilars, can impact the pricing and market share of the drug. Patent expirations and the entry of generic versions can significantly reduce the sales of branded drugs[3].
Price Projections
Factors Influencing Price
Several factors influence the pricing of pharmaceuticals:
- Regulatory Environment: Changes in regulatory policies, such as those related to drug pricing transparency, can affect how prices are set and reported[5].
- Market Demand: The demand for the drug, driven by factors like disease prevalence and treatment guidelines, can impact pricing.
- Competition: The level of competition from other drugs, including generics and biosimilars, plays a crucial role in price setting.
- Cost of Production: The cost of manufacturing, research, and development also influences the final price of the drug.
Historical Price Trends
For a more accurate price projection, historical price data would be essential. Here is an example of how price trends can be analyzed using historical data:
- Example: For a drug like Imatinib Mesylate (NDC 00378-2245), the price per unit has fluctuated over time. From $0.50016 per unit in September 2024 to $0.66780 per unit in December 2024, there was a noticeable increase[2].
Projecting Prices for NDC 82584-0003
Given the lack of specific data on the drug associated with NDC 82584-0003, we can only make general projections based on industry trends:
- Potential Price Increase: If the drug is a brand name drug, it might follow the median price increase trend of 13.4% observed in 2022. For generic drugs, the median increase was 19.9%[2][5].
- Market Growth: If the drug is in a high-growth therapeutic area, its price could be influenced by the overall market expansion and demand.
Key Takeaways
- NDC System: The NDC is a critical identifier for drug products, providing detailed information about the manufacturer, product, and packaging.
- Market Trends: The pharmaceutical industry is characterized by significant price increases, with brand name drugs seeing a median increase of 13.4% and generic drugs seeing a median increase of 19.9% in 2022.
- Therapeutic Areas: High-growth areas like oncology, particularly NSCLC, are driven by the adoption of premium-priced therapies.
- Price Projections: Without specific data, price projections for NDC 82584-0003 would need to consider broader industry trends and the therapeutic class of the drug.
FAQs
Q: What is the National Drug Code (NDC) and its significance?
A: The NDC is a unique, three-segment number that identifies drug products, including the labeler, product, and package code. It is crucial for regulatory compliance and market tracking[1][4].
Q: How do price increases in the pharmaceutical industry affect drug prices?
A: Price increases can be driven by various factors, including regulatory changes, market demand, and competition. The median price increase for brand name drugs was 13.4% in 2022, while generic drugs saw a median increase of 19.9%[2][5].
Q: What are the key drivers of the NSCLC market growth?
A: The NSCLC market is driven by the increasing incorporation of immunotherapies and targeted therapies, particularly in the first-line treatment setting. Drugs like Keytruda, Opdivo, and Tecentriq are expected to achieve blockbuster status by 2025[3].
Q: How do patent expirations affect drug prices?
A: Patent expirations lead to the entry of generic versions, which can significantly reduce the sales of branded drugs. For example, the sales of Tarceva and Alimta are expected to decrease substantially due to patent expirations[3].
Q: What role does the FDA play in maintaining the NDC Directory?
A: The FDA is responsible for maintaining the accuracy and integrity of the NDC Directory. Drug establishments must update their listing data regularly, and the FDA monitors compliance through its regulatory programs[1][4].
Sources
- FDA's National Drug Code Directory - FDA
- Latest drug prices and trends for NDC 00378-2245 - DrugPatentWatch
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
- National Drug Code Database Background Information - FDA
- Prescription Drug Price Transparency Results and Recommendations - Oregon Drug Price Transparency Program
