Introduction
The drug identified by the National Drug Code (NDC) 00378-7502, which is the trade name BREYNA manufactured by Mylan Pharmaceuticals Inc., falls under the category of pharmaceutical products that are subject to various market and regulatory forces. Here, we will analyze the market dynamics and project price trends for this specific drug.
Drug Overview
BREYNA, with the NDC 00378-7502, is a product of Mylan Pharmaceuticals Inc., a well-known labeler in the pharmaceutical industry. This drug is part of Mylan's extensive portfolio, which includes a wide range of therapeutic products[5].
Medicare's Market Share and Pricing Impact
Medicare's market share can significantly influence the pricing of pharmaceutical drugs. If Medicare has a substantial market share for BREYNA, the manufacturer may have greater flexibility to set prices without fearing significant sales declines. This is particularly true if the drug is a single-source product, meaning it has no direct competitors. Medicare's dominance in the market for certain drugs can reduce manufacturers' incentives to price drugs competitively[4].
Industry Trends and Price Erosion
The pharmaceutical industry is subject to various trends that can affect pricing:
- Generic Drug Sector: Mid-single-digit percent annual price erosion is expected in the generic drug sector, but this does not directly impact branded or specialty drugs like BREYNA.
- Biosimilars and Competitive Products: While biosimilars and other competitive products may influence pricing strategies, they are unlikely to directly affect BREYNA if it is a unique product with no direct generic competition[4].
Market Segments and Growth
The market for drug delivery systems, particularly injectables, is expected to grow significantly. If BREYNA is administered via injection or another route that is seeing significant market growth, this could support higher pricing due to increased demand and technological advancements in drug delivery systems[4].
Regulatory Landscape
The regulatory landscape plays a crucial role in drug pricing. Changes in regulatory frameworks, such as those related to the Medicare Drug Price Negotiation Program, can set benchmarks for future pricing discussions. However, these negotiations may not directly apply to BREYNA unless it is selected for negotiation[4].
Price Changes and Trends
Historically, the pharmaceutical industry has seen significant price changes, especially in the beginning of the year and mid-year. For example, from January 2022 to January 2023, the average price increase for single-source drugs was 7.4%, while multi-source drugs saw an average increase of 26.0%[2].
Specific Price Projections for NDC: 00378-7502
Given the factors above, here are some key points to consider for price projections of BREYNA:
- Medicare Influence: If Medicare has a significant market share for BREYNA, prices may be less competitive.
- Negotiated Prices: CMS negotiations could set pricing benchmarks, but this may not directly apply to BREYNA unless selected for negotiation.
- Industry Trends: As a branded or specialty drug, BREYNA is less likely to be affected by generic price erosion.
- Market Growth: The growing demand for advanced drug delivery systems could support higher pricing due to increased demand and technological advancements.
Data from the NDC Directory
The FDA's New NDC Directory, which is updated daily, includes comprehensive data on all listed drugs in their final marketed form. This directory provides data elements such as the Drug Enforcement Administration schedule and pharmacological class, which can be useful in understanding the regulatory and market positioning of BREYNA[1].
Expert Insights and Statistics
Industry experts predict that the biopharma and biotech sectors will continue to grow, driven by advancements in technological capabilities and evolving regulatory frameworks. The biopharma market is projected to grow at a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029, which could influence pricing strategies for drugs like BREYNA[3].
For instance, in the period from January 2022 to January 2023, the average price increase for prescription drugs was $589.68 per drug, which is nearly 3.5 times the average price change between 2021 and 2022. This trend indicates that price increases are often concentrated in more expensive drug products, which could impact the pricing of BREYNA if it falls into this category[2].
Key Takeaways
- Medicare's Market Share: Significant market share can reduce competitive pricing pressures.
- Negotiated Prices: CMS negotiations can set pricing benchmarks but may not directly apply to BREYNA unless selected for negotiation.
- Industry Trends: Branded and specialty drugs are less affected by generic price erosion.
- Market Growth: Growing demand for advanced drug delivery systems supports higher pricing.
- Regulatory Landscape: Evolving regulatory frameworks can influence pricing strategies.
FAQs
Q: How does Medicare's market share affect the pricing of drugs like BREYNA?
A: Medicare's significant market share can reduce competitive pricing pressures, allowing manufacturers to set prices with less fear of sales declines.
Q: What impact do generic drugs have on the pricing of branded drugs like BREYNA?
A: Generic drugs typically do not directly impact the pricing of branded or specialty drugs like BREYNA, as these drugs maintain higher prices due to their unique therapeutic benefits and lack of direct generic competition.
Q: How do technological advancements in drug delivery systems influence pricing?
A: Technological advancements in drug delivery systems, such as injectables, can support higher pricing due to increased demand and the value added by these innovations.
Q: What role do regulatory changes play in drug pricing?
A: Regulatory changes, such as those related to the Medicare Drug Price Negotiation Program, can set pricing benchmarks and influence future pricing discussions.
Q: What are the projected growth rates for the biopharma and biotech industries, and how might this impact BREYNA?
A: The biopharma market is projected to grow at a CAGR of 7.56% between 2024 and 2029. This growth, driven by technological advancements and evolving regulatory frameworks, could support higher pricing for drugs like BREYNA.
Sources
- FDA New NDC Directory: "NDC Directory" - YouTube
- ASPE Brief: "Changes in the List Prices of Prescription Drugs, 2017-2023" - ASPE
- TFS CRO Predictions: "5 Predictions for the Biopharma and Biotech Industries in 2025" - TFS CRO
- DrugPatentWatch: "Market Analysis and Financial Projection for NDC: 00002-8147" - DrugPatentWatch
- FindACode: "Mylan Pharmaceuticals Inc. - List of Drugs - NDC Labeler" - FindACode