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 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 its packaging[1][4].
Identifying the Drug
The NDC 61874-0075 can be broken down into its three segments:
- Labeler Code: This identifies the firm that manufactures, repackages, or relabels the drug.
- Product Code: This specifies the strength, dosage form, and formulation of the drug.
- Package Code: This indicates the package size and type.
To get specific details about the drug, one would need to look up this NDC in the FDA's National Drug Code Directory or other databases that track drug listings.
Market Trends in Pharmaceutical Prices
Overall Pharmaceutical Market
The pharmaceutical market is experiencing significant trends that impact drug pricing. For instance, Vizient projects a 3.81% drug price inflation rate for 2025, driven by factors such as expanding indications for previously approved medications and the introduction of high-cost cell and gene therapies[2].
Global Price Comparisons
Prices of drugs in the U.S. are notably higher compared to other regions. According to an ASPE issue brief, the average price per unit in the U.S. is 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world. This disparity is due to both higher prices for the same drugs and a drug mix that skews towards more expensive compounds[3].
Segment-Specific Trends
- Small Molecule Drugs: U.S. sales revenues for small molecule drugs grew by 4% between 2017 and 2022, while they contracted in other regions.
- Biologic Products: The U.S. saw a significant 61% growth in sales revenues for biologic products during the same period, highlighting the increasing importance and cost of biologics in the market[3].
Price Projections and Inflation
Given the overall trend of increasing drug prices, it is likely that the drug identified by NDC 61874-0075 will also experience price inflation. Here are some key points to consider:
- General Inflation Rate: With an expected overall drug price inflation rate of 3.81% for 2025, it is reasonable to assume that this drug will see a similar or slightly higher increase depending on its market segment and demand[2].
- Specific Market Factors: If the drug falls under a category with high demand or limited competition, such as diabetes or biologic treatments, it may experience higher price increases compared to the general inflation rate[3].
Impact of Regulatory Changes
Medicare Drug Price Negotiation Program
The Medicare Drug Price Negotiation Program, part of the Inflation Reduction Act, aims to reduce drug costs for Medicare beneficiaries. While this program specifically targets drugs covered under Medicare Part D, it sets a precedent for price negotiations and could influence broader market pricing. For example, negotiated prices for certain drugs have resulted in significant savings, with discounts ranging from 38% to 79% from the list prices[5].
FDA Regulations and Listings
The FDA's National Drug Code Directory and the Drug Registration and Listing System ensure that all commercially distributed drugs are properly listed and updated. Any changes in the listing status or marketing start/end dates can affect the availability and pricing of the drug[1][4].
Key Takeaways
- NDC Identification: The NDC 61874-0075 uniquely identifies a drug product, including its manufacturer, formulation, and packaging.
- Market Trends: The pharmaceutical market is experiencing price inflation, with the U.S. having significantly higher prices compared to other regions.
- Price Projections: The drug is likely to see a price increase in line with the general 3.81% inflation rate for 2025, potentially higher if it is in a high-demand category.
- Regulatory Impact: Programs like the Medicare Drug Price Negotiation Program may influence broader market pricing strategies and could lead to future price adjustments.
FAQs
Q: What does the National Drug Code (NDC) represent?
The NDC is a unique, three-segment number that identifies a drug product, including the labeler, product, and package code.
Q: How does the FDA track and update drug listings?
The FDA uses the National Drug Code Directory and the Drug Registration and Listing System to track and update drug listings, with updates required in June and December each year[1][4].
Q: What is the projected drug price inflation rate for 2025?
Vizient projects a 3.81% overall drug price inflation rate for 2025[2].
Q: Why are drug prices in the U.S. higher than in other regions?
Drug prices in the U.S. are higher due to both higher prices for the same drugs and a drug mix that skews towards more expensive compounds[3].
Q: How does the Medicare Drug Price Negotiation Program affect drug prices?
The program negotiates lower prices for selected drugs under Medicare Part D, resulting in significant savings for beneficiaries and potentially influencing broader market pricing strategies[5].
Sources
- FDA's National Drug Code Directory - FDA
- Vizient projects drug price inflation at 3.81% - Vizient, Inc.
- International Market Size and Prices - ASPE
- National Drug Code Database Background Information - FDA
- Medicare Drug Price Negotiation Program - CMS