Introduction to NDC 51991-0526
The National Drug Code (NDC) 51991-0526 corresponds to a specific drug product, which is essential to identify for market analysis and price projections. This NDC is associated with a human prescription drug, and understanding its components and market dynamics is crucial.
Drug Identification
- NDC Number: 51991-0526
- Labeler Name: Breckenridge Pharmaceutical, Inc. (or a similar labeler, as NDCs can be assigned by various manufacturers or labelers)[5].
- Generic Name: This would typically be the active ingredient of the drug, such as Lacosamide for another product from the same labeler[5].
Market Context
Pharmaceutical Market Trends
The pharmaceutical market, particularly the biopharma and biotech sectors, is experiencing significant growth and transformation. The biopharma market size was estimated to be over $400 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. The biotech sector is also growing rapidly, with a market size of nearly $500 billion in 2020 and an estimated CAGR of 9.4% between 2021 and 2027[3].
Regulatory Environment
The regulatory landscape is evolving to keep pace with innovation. This includes changes in clinical trial designs, precision medicine, and the use of AI/ML technologies. These advancements can influence the development, approval, and pricing of drugs[3].
Price Transparency and Competition
National Drug Code Directory
The FDA's National Drug Code Directory provides comprehensive information on drug products, including finished and unfinished drugs. This directory is updated daily and includes data on active and certified drugs submitted by labelers. For drugs like the one associated with NDC 51991-0526, this directory would contain essential product listing data[1].
Price Dynamics
Price transparency programs and competition in the generics market play a significant role in drug pricing. For instance, competition in the generics market can significantly reduce drug prices. A case in point is the generic version of fingolimod, which saw a price reduction of 84% to 97% due to competition[4].
Price Projections
Historical Price Trends
To project prices for the drug associated with NDC 51991-0526, it is crucial to analyze historical price trends. Many prescription drugs have seen substantial price increases over the years. For example, nine out of ten drugs selected for Medicare Part D price negotiations had list price increases ranging from 20% to 55% between 2018 and 2023[2].
Impact of Negotiations and Regulations
Beginning in January 2026, Medicare Part D will implement negotiated prices for certain drugs, resulting in discounts ranging from 38% to 79% compared to list prices. Such negotiations and regulatory changes can significantly impact the pricing of drugs, including those in the generics market[2].
Generic Market Competition
If the drug associated with NDC 51991-0526 is a generic or has generic competitors, the prices are likely to be influenced by market competition. Generic drugs often see price reductions as more manufacturers enter the market[4].
Market Analysis
Demand and Supply
The demand for the drug will be influenced by factors such as the prevalence of the condition it treats, patient preferences, and healthcare policies. Supply-side factors include production costs, regulatory approvals, and the number of manufacturers producing the drug.
Competitive Landscape
Understanding the competitive landscape is crucial. If the drug is part of a highly competitive market, prices are likely to be lower due to competition. Conversely, if it has limited competition, prices might be higher.
Key Takeaways
- Regulatory Environment: Evolving regulatory frameworks and price transparency programs can significantly impact drug pricing.
- Market Competition: Competition in the generics market can lead to substantial price reductions.
- Historical Trends: Analyzing historical price trends is essential for projecting future prices.
- Negotiations and Discounts: Medicare Part D negotiations and similar programs can result in significant discounts.
- Technological Advancements: Innovations in clinical trial designs and precision medicine can influence drug development and pricing.
FAQs
1. What is the National Drug Code (NDC) and how is it used?
The National Drug Code (NDC) is a unique three-segment number used by the FDA to identify drugs. It is essential for tracking and reporting drug products in the U.S. market[1].
2. How does competition in the generics market affect drug prices?
Competition in the generics market can significantly reduce drug prices. For example, the generic version of fingolimod saw a price reduction of 84% to 97% due to competition[4].
3. What impact do Medicare Part D negotiations have on drug prices?
Medicare Part D negotiations can result in substantial discounts, ranging from 38% to 79% compared to list prices, starting in January 2026[2].
4. How do regulatory changes influence the pharmaceutical market?
Regulatory changes, such as evolving clinical trial designs and precision medicine, can shape the future of drug development and pricing. These changes aim to make healthcare more personalized, efficient, and accessible[3].
5. What role does the FDA's National Drug Code Directory play in market analysis?
The FDA's National Drug Code Directory provides comprehensive information on drug products, including finished and unfinished drugs, which is crucial for market analysis and tracking price trends[1].
Sources
- FDA's National Drug Code Directory - FDA
- Medicare Drug Price Negotiation Program - ASPE, HHS.gov
- 5 Predictions for the Biopharma and Biotech Industries in 2025 - TFS CRO
- Prescription Drug Price Transparency Program results and market dynamics - Oregon Department of Consumer and Business Services
- NDC 51991-350 Oral Tablet, Film Coated LACOSAMIDE Drug - FDA.report
