Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by its National Drug Code (NDC), it is crucial to understand what the NDC represents. The NDC is a unique, three-segment number that identifies a drug product. It consists of a labeler code, a product code, and a package code, which together provide a universal product identifier for human drugs[1][5].
Identifying the Drug
The NDC 63304-0479 can be broken down as follows:
- Labeler Code: The first segment identifies the labeler, which is the firm that manufactures, repackages, or relabels the drug.
- Product Code: The second segment identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: The third segment identifies the package size and type.
To proceed with the analysis, one would need to identify the specific drug associated with this NDC. However, without direct access to the FDA's National Drug Code Directory or other databases, we cannot specify the exact drug here.
Market Trends and Price Inflation
Overall Pharmaceutical Market
The pharmaceutical market is expected to experience several trends and challenges in 2025. One key trend is the projected drug price inflation rate, estimated at 3.81% for 2025, according to Vizient's Pharmacy Market Outlook. This inflation is partly driven by the expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies[2].
Life Sciences Industry Outlook
The life sciences industry is facing significant issues related to pricing and access to drugs and medical devices. Nearly half of the C-suite executives surveyed by Deloitte expect pricing and access to significantly affect their strategies in 2025. Additionally, competition from generic drugs and biosimilars, as well as the patent cliff, are major concerns. The biopharma industry is set to lose over $300 billion in sales through 2030 due to expiring patents on high-revenue products[3].
Specific Market Segments
Non-Small Cell Lung Cancer (NSCLC) Market
For example, in the NSCLC market, targeted therapies are expected to drive significant growth. Drugs like AstraZeneca’s Tagrisso and Roche’s Avastin are projected to achieve high sales, with Tagrisso expected to reach $1.7 billion in sales by 2025, driven by its uptake in EGFR-mutant patients. This segment illustrates how specific therapeutic areas can have robust growth despite broader industry challenges[4].
Price Projections
General Trends
Given the overall trend of drug price inflation, it is likely that the price of the drug associated with NDC 63304-0479 will increase. However, the exact magnitude of this increase would depend on various factors, including the drug's therapeutic class, market competition, and regulatory environment.
Impact of Generic and Biosimilar Competition
If the drug is a branded product facing competition from generics or biosimilars, its price could be more stable or even decrease as generic alternatives enter the market. This is a common scenario in many therapeutic areas where patent expirations lead to increased competition[3].
Regulatory and Compliance Considerations
FDA Listings and Updates
The FDA requires drug establishments to update their drug listing data in June and December of each year. This ensures that the NDC Directory remains accurate and up-to-date. Any changes in the drug's status, such as a change in formulation or packaging, would need to be reflected in these updates[1][5].
Conclusion
Key Takeaways
- NDC Identification: The NDC is a critical identifier for drug products, consisting of a labeler code, product code, and package code.
- Market Trends: The pharmaceutical market is expected to see a 3.81% price inflation rate in 2025, driven by various factors including new indications and high-cost therapies.
- Life Sciences Outlook: Pricing and access issues, along with competition from generics and biosimilars, are significant concerns for the life sciences industry.
- Specific Market Segments: Targeted therapies in areas like NSCLC are expected to drive growth, despite broader industry challenges.
- Price Projections: Prices are likely to increase due to inflation, but competition from generics and biosimilars could stabilize or reduce prices for certain drugs.
FAQs
Q: What is the National Drug Code (NDC) and how is it structured?
A: The NDC is a unique, three-segment number that identifies a drug product. It includes a labeler code, a product code, and a package code.
Q: What are the key factors driving drug price inflation in 2025?
A: Expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies are key drivers.
Q: How does the life sciences industry view pricing and access issues in 2025?
A: Nearly half of C-suite executives expect pricing and access to significantly affect their strategies, with competition from generics and biosimilars being major concerns.
Q: What is the projected growth in the NSCLC market by 2025?
A: The NSCLC market is expected to grow significantly, with targeted therapies contributing substantially, and drugs like Tagrisso achieving high sales.
Q: How often must drug establishments update their drug listing data with the FDA?
A: Drug establishments must update their drug listing data in June and December of each year.
Sources
- FDA: National Drug Code Database Background Information - FDA
- Vizient, Inc.: Vizient projects drug price inflation at 3.81%
- Deloitte Insights: 2025 life sciences outlook
- GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
- FDA: National Drug Code Directory - FDA
