Market Analysis and Price Projections for the Drug NDC: 46122-0580
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug, it is crucial to understand the National Drug Code (NDC) system. The NDC is a unique 10-digit or 11-digit, 3-segment number that serves as a universal product identifier for human drugs in the United States. It identifies the labeler, the product, and the commercial package size[1][5].
Breakdown of the NDC: 46122-0580
- Labeler Code: The first segment (46122) identifies the labeler, which could be the drug manufacturer, repackager, or distributor.
- Product Code: The second segment (0580) identifies the specific strength, dosage form, and formulation of the drug for that labeler.
- Package Code: The third segment identifies the package size and type.
Market Trends and Drug Pricing
General Market Trends
The pharmaceutical market is experiencing several key trends that impact drug pricing:
- Specialty Pharmaceuticals: There is a significant increase in the utilization of specialty pharmaceuticals, which treat high-cost, complex, or chronic conditions. This segment is expected to drive a 3.8% increase in drug prices, the highest projected increase since July 2019[4].
- Biosimilars: Biosimilars are expected to grow in market share, potentially affecting the pricing of originator products. However, their impact on the specific drug with NDC 46122-0580 would depend on whether it has a biosimilar counterpart[4].
Price Inflation Projections
- Overall Market: Vizient projects a 3.8% increase in drug prices, driven largely by specialty pharmaceuticals. This trend indicates that many drugs, including those in the same therapeutic class as the one with NDC 46122-0580, may see price increases[4].
- Specific Drug Price Changes: Without specific data on the drug identified by NDC 46122-0580, it is challenging to predict exact price changes. However, if the drug falls under a category experiencing significant price increases (e.g., specialty pharmaceuticals), it may follow similar trends.
Impact of Regulatory Changes
FDA Proposals on NDC Format
The FDA has proposed a rule to adopt a single, universal 12-digit NDC format to replace the current 10-digit format. This change aims to minimize the impact of running out of 10-digit NDCs and to standardize the format for all stakeholders. While this change does not directly affect current pricing, it could streamline processes and potentially reduce administrative costs associated with drug labeling and tracking[1].
Medicare Drug Price Negotiation
Beginning in January 2026, Medicare will implement negotiated prices for certain drugs, which could significantly impact the pricing landscape. For the first year, nine of the ten selected drugs had list price increases ranging from 20% to 55% between 2018 and 2023. The negotiated prices resulted in discounts ranging from 38% to 79% compared to list prices. If the drug with NDC 46122-0580 is included in future negotiation lists, it could see substantial price reductions[2].
Role of Data and AI in Pharmaceutical Pricing
Use of External Data and AI
The pharmaceutical industry is increasingly leveraging external data and artificial intelligence (AI) to inform pricing strategies and predict market trends. AI can help analyze large datasets to identify patterns and predict future price changes, which could be crucial for managing the pricing of drugs like the one with NDC 46122-0580[3].
Key Takeaways
- NDC Understanding: The NDC is a critical identifier that helps in tracking and managing drug products.
- Market Trends: Specialty pharmaceuticals and biosimilars are key drivers of current market trends.
- Price Projections: A general 3.8% increase in drug prices is projected, with potential for higher increases in certain categories.
- Regulatory Changes: FDA proposals and Medicare negotiations could impact pricing and administrative processes.
- AI and Data: The use of AI and external data is becoming more prevalent in predicting and managing drug prices.
FAQs
What is the National Drug Code (NDC)?
The NDC is a unique 10-digit or 11-digit, 3-segment number that identifies the labeler, product, and commercial package size of a drug in the United States.
How are NDCs formatted?
NDCs are formatted in one of the following configurations: 4-4-2, 5-3-2, or 5-4-1, identifying the labeler, product, and package size respectively.
What is the impact of FDA's proposed NDC format change?
The proposed change to a 12-digit NDC format aims to standardize the format and prevent the depletion of 10-digit NDCs, potentially streamlining administrative processes.
How do Medicare negotiations affect drug prices?
Medicare negotiations can result in significant discounts, ranging from 38% to 79% compared to list prices, for selected drugs.
What role does AI play in pharmaceutical pricing?
AI helps analyze large datasets to predict market trends and inform pricing strategies, making it a valuable tool in managing drug prices.
Sources
- National Drug Codes Explained: What You Need to Know - Drugs.com
- Medicare Drug Price Negotiation Program - ASPE, HHS.gov
- 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch - Intelligencia.ai
- Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals - Vizientinc.com
- National Drug Code Database Background Information - FDA.gov
