Understanding the NDC Code
The NDC code 10702-0040 is a unique identifier for a specific drug product. This code is part of the National Drug Code (NDC) system, which is used to identify prescription drugs, over-the-counter (OTC) drugs, and insulin products in the United States. The NDC code is a 10-digit, three-segment number that identifies the labeler, product, and package size of the drug[1].
Drug Product Identification
For the NDC code 10702-0040, here is a breakdown of what each segment represents:
- Labeler Code: The first segment (10702) is assigned by the FDA and identifies the firm that manufactures, repacks, or distributes 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.
Market Context
To analyze the market and project prices for this drug, it is crucial to understand the broader pharmaceutical market trends.
Prescription Drug Market Trends
The prescription drug market is influenced by several factors, including regulatory oversight, technological advancements, and consumer behavior. Here are some key trends:
- Price Transparency: There is a growing push for price transparency in the pharmaceutical industry. Programs like Oregon's Prescription Drug Price Transparency Act require manufacturers to report price increases and other cost-related information, which helps in understanding the factors influencing drug prices[2].
- Price Increases: The percentage of drugs with price increases has been decreasing, but the average percent of increase remains higher than the consumer price index (CPI-U). For example, in 2022, the average percent increase was 10.79%, which is higher than the CPI-U of 6.5%[4].
Biopharma and Biotech Industry Growth
The biopharma and biotech industries are experiencing rapid growth, driven by technological advancements and evolving regulatory frameworks. The market size for biopharmaceuticals is projected to grow at a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029, while the biotech market is expected to grow at a CAGR of 9.4% between 2021 and 2027[3].
Price Projections for NDC: 10702-0040
Given the trends and factors influencing the pharmaceutical market, here are some considerations for price projections:
Historical Price Data
To project future prices, it is essential to analyze historical price data for the drug. For instance, if the drug has experienced price increases in the past, understanding the magnitude and frequency of these increases can help in predicting future trends.
Regulatory and Market Factors
- Regulatory Oversight: Changes in regulatory policies, such as those related to price transparency and affordability boards, can impact drug prices. For example, the creation of prescription drug affordability boards in some states could lead to upper payment limits for certain drugs, potentially affecting prices[2].
- Market Competition: The level of competition in the market, including the presence of generic alternatives, can also influence prices. Generic drugs often see significant price decreases, which can impact the pricing strategy for brand-name drugs[4].
Consumer and Payer Dynamics
- Consumer Behavior: Consumer behavior, such as adherence to medication due to cost concerns, can affect demand and subsequently prices. A significant portion of Americans report not taking their medications as prescribed due to cost, which can impact the overall market dynamics[2].
- Payer Negotiations: Rebates and discounts negotiated by pharmacy benefit managers (PBMs) and other payers can also influence the net cost of drugs to consumers and payers. For brand drugs, rebates can significantly offset costs, resulting in net costs below the wholesale acquisition cost (WAC)[4].
Example: Oxycodone Hydrochloride Pricing
To illustrate how these factors can influence pricing, consider Oxycodone Hydrochloride, another product from the same labeler (KVK-TECH, INC). The pricing for Oxycodone Hydrochloride can be affected by similar market and regulatory factors. For instance, if there is a significant increase in the price of Oxycodone Hydrochloride due to supply chain issues or regulatory changes, it could set a precedent for other drugs from the same labeler[5].
Key Takeaways
- Regulatory Transparency: Increased regulatory transparency and reporting requirements can help in understanding and predicting price trends.
- Market Competition: The presence of generic alternatives and competitive market dynamics can significantly impact the pricing of brand-name drugs.
- Consumer and Payer Behavior: Consumer adherence to medication and payer negotiations play crucial roles in determining the net cost of drugs.
- Technological and Regulatory Advancements: The biopharma and biotech industries' rapid growth and evolving regulatory frameworks will continue to shape the pharmaceutical market.
FAQs
-
What is the NDC code, and how is it structured?
- The NDC code is a 10-digit, three-segment number that identifies the labeler, product, and package size of a drug. The first segment is the labeler code, the second is the product code, and the third is the package code[1].
-
Why are some drug products not included in the NDC Directory?
- Drug products may not be included if they are not prescription drugs, OTC drugs, or insulin products, or if the firm has not complied with listing obligations or has notified the FDA that the product is no longer being marketed[1].
-
How do regulatory policies impact drug prices?
- Regulatory policies such as price transparency acts and the creation of prescription drug affordability boards can influence drug prices by requiring manufacturers to report price increases and potentially setting upper payment limits[2].
-
What role do pharmacy benefit managers (PBMs) play in drug pricing?
- PBMs negotiate rebates and discounts with manufacturers, which can significantly offset the costs to payers and result in net costs below the wholesale acquisition cost (WAC)[4].
-
How does consumer behavior affect drug prices?
- Consumer behavior, such as not taking medications as prescribed due to cost concerns, can impact demand and subsequently influence pricing strategies and market dynamics[2].
Sources
- FDA - National Drug Code Database Background Information
- Oregon’s Prescription Drug Price Transparency Program - Annual Report 2022
- TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
- Maine Health Data Organization - Rx Transparency Report 2024
- PharmaCompass - NDC Code 10702-009-50