Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its NDC number, it is crucial to understand what the NDC represents. The National Drug Code (NDC) is a unique, three-segment number that serves as the FDA’s identifier for drugs. This code is used in the FDA's National Drug Code Directory, which contains information on active and certified finished and unfinished drugs submitted by labelers[1][4].
Identifying the Drug
The NDC number 45963-0479 can be broken down into three segments: the labeler code, the product code, and the package code. Here’s a brief explanation of each segment:
- Labeler Code: The first segment, assigned by the FDA, identifies the firm that manufactures, repackages, or relabels the drug.
- Product Code: The second segment identifies a specific strength, dosage form, and formulation for a particular firm.
- Package Code: The third segment identifies the package sizes and types[4].
Market Analysis
Overall Market Trends
For the pharmaceutical industry, overall market trends play a significant role in price projections. As of 2025, the Vizient Pharmacy Market Outlook projects a stable pricing environment with a 0.00% overall drug price inflation rate. However, this does not account for individual drug price fluctuations, which can be influenced by various factors such as competition, regulatory changes, and market demand[2].
Specific Drug Market Analysis
To provide a detailed analysis for the drug with NDC 45963-0479, we need to identify the specific drug product associated with this code. Here are some general insights that could apply:
- Generic vs. Brand Name Drugs: If the drug is a generic, it might experience price increases similar to those reported in other markets. For example, in Oregon's transparency program, the median price increase for generic drugs was 19.9% in 2022. For brand name drugs, the median price increase was 13.4%[2].
- Innovative Therapies: If the drug belongs to a new therapeutic class, such as gene therapies or targeted therapies, it may command higher prices due to its innovative nature and the value it brings to patients. For instance, in the Non-Small Cell Lung Cancer (NSCLC) market, immunotherapies like Keytruda, Opdivo, and Tecentriq are projected to achieve significant sales due to their efficacy and market demand[3].
Price Projections
Factors Influencing Price
Several factors can influence the price projections for the drug with NDC 45963-0479:
- Competition: The presence of competitors, whether generic or brand name, can significantly impact pricing. In markets with high competition, prices tend to be lower.
- Regulatory Environment: Changes in FDA regulations or approval processes can affect the pricing strategy of pharmaceutical companies.
- Market Demand: The demand for the drug, driven by factors such as disease prevalence, treatment efficacy, and patient preferences, can influence pricing.
- Patent Expirations: If the drug is nearing patent expiration, generic versions may enter the market, potentially reducing prices[3].
Example from Similar Markets
In the NSCLC market, for instance, targeted therapies and immunotherapies are driving significant growth. Drugs like AstraZeneca’s Tagrisso and Roche’s Avastin are projected to achieve blockbuster status by 2025, with sales driven by their uptake in various treatment settings. However, the impact of generic versions of older drugs, such as Tarceva and Alimta, will also be felt as their sales decline post-patent expiration[3].
Data from the NDC Directory
The FDA's National Drug Code Directory provides critical information about the drug, including its marketing start and end dates, which can help in understanding its commercial distribution status. For compounded drug products, the directory includes information reported by outsourcing facilities, which can be useful if the drug in question falls under this category[1].
Price Trends and Projections
Without specific data on the drug associated with NDC 45963-0479, here are some general price trends that might apply:
- Stable Pricing Environment: Given the overall stable pricing environment projected for 2025, the drug might not experience significant price inflation unless it is part of a highly competitive or innovative market segment.
- Generic and Brand Name Price Increases: If the drug is a generic, it could see price increases similar to those seen in other generic drugs. For brand name drugs, the price increase might be more moderate but still significant due to their market value and demand[2].
Conclusion
The market analysis and price projections for the drug with NDC 45963-0479 depend on various factors including its classification as a generic or brand name drug, its therapeutic class, market demand, and regulatory environment. Here are some key takeaways:
- Understand the NDC: Break down the NDC to identify the labeler, product, and package details.
- Market Trends: Consider overall market trends and specific trends within the drug's therapeutic class.
- Competition and Regulation: Analyze the competitive landscape and regulatory changes that could impact pricing.
- Demand and Innovation: Evaluate the demand for the drug and its innovative value to patients.
Key Takeaways
- The NDC is a critical identifier for drug products, helping in market analysis and price projections.
- Market trends, competition, and regulatory changes significantly influence drug pricing.
- Innovative therapies and high-demand drugs tend to command higher prices.
- Generic versions of drugs can reduce prices post-patent expiration.
FAQs
Q: What is the National Drug Code (NDC) and how is it used?
A: The National Drug Code (NDC) is a unique, three-segment number assigned by the FDA to identify drug products. It is used in the FDA's National Drug Code Directory to track and report information about finished and unfinished drugs.
Q: How do I identify the drug associated with a specific NDC number?
A: You can identify the drug by breaking down the NDC into its three segments: the labeler code, product code, and package code, and then referencing the FDA's NDC Directory.
Q: What factors influence the price of a drug?
A: Factors such as competition, regulatory changes, market demand, and the drug's therapeutic class and innovation level can influence its price.
Q: How do generic drugs affect the pricing of brand name drugs?
A: Generic drugs can reduce the prices of brand name drugs by introducing competition into the market, especially after the brand name drug's patent expires.
Q: What is the significance of the FDA's National Drug Code Directory in market analysis?
A: The directory provides essential information about drug products, including their marketing start and end dates, which helps in understanding their commercial distribution status and market trends.
