Market Analysis and Price Projections for NDC: 82009-0094
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug identified by the National Drug Code (NDC) 82009-0094, it is crucial to first understand what the NDC represents. The NDC is a unique, three-segment number that serves as the FDA’s identifier for drugs. It consists of a labeler code, a product code, and a package code[3].
Identifying the Drug
The NDC 82009-0094 is associated with Quallent Pharmaceuticals Health LLC, a labeler that manufactures, prepares, propagates, compounds, or processes drugs for commercial distribution in the U.S.[5].
Market Context
Over-The-Counter (OTC) and Prescription Drugs Market
The U.S. pharmaceutical market is diverse, with both OTC and prescription drugs playing significant roles. The OTC drugs market, in particular, is expected to grow from USD 42.80 billion in 2024 to USD 53 billion by 2029, at a CAGR of 4.40%. This growth is driven by the high cost of prescription drugs, leading consumers to opt for more affordable OTC alternatives[4].
Prescription Drug Market Trends
For prescription drugs, the market is influenced by various factors including the introduction of new therapies, patent expirations, and the rise of generic and biosimilar drugs. For instance, in the Non-Small Cell Lung Cancer (NSCLC) market, the introduction of immunotherapies and targeted therapies is expected to drive significant growth. However, patent expirations of blockbuster drugs can limit this growth[2].
Specific Market Analysis for NDC 82009-0094
Labeler and Product Information
To conduct a detailed market analysis, one needs to identify the specific drug product associated with the NDC 82009-0094. This involves looking into the FDA's National Drug Code Directory or contacting the labeler directly for detailed product information.
Market Size and Growth
If the drug is an OTC product, it would be part of the growing OTC market, driven by consumer preference for affordable healthcare options. For prescription drugs, the market size and growth would depend on factors such as the therapeutic area, competition from generics or biosimilars, and the drug's position within its treatment algorithm.
Pricing Trends
Pricing trends for pharmaceuticals are heavily influenced by regulatory policies, competition, and the overall healthcare landscape. The high cost of prescription drugs has led to a significant shift towards OTC drugs and generics. For example, in 2022, over 1,216 drugs experienced price hikes, with some increasing by more than 500%[4].
Price Projections
Impact of Generics and Biosimilars
If the drug associated with NDC 82009-0094 is a branded prescription drug, its price could be affected by the introduction of generic or biosimilar versions. For instance, in the NSCLC market, the sales of branded drugs like Avastin are expected to be impacted by biosimilar competition, with biosimilar bevacizumab projected to achieve $1 billion in sales by 2025[2].
Regulatory and Market Factors
Price projections would also consider regulatory approvals, new product launches, and changes in market demand. For OTC drugs, new approvals and launches, such as Marksans Pharma's Guaifenesin extended-release tablets, can increase product availability and drive market growth[4].
Competitive Landscape
The competitive landscape for the drug associated with NDC 82009-0094 would involve analyzing the market share of the labeler, Quallent Pharmaceuticals Health LLC, as well as other competitors in the same therapeutic area. This includes both international and local companies that hold significant market shares[4].
Key Takeaways
- Market Growth: The U.S. pharmaceutical market, including both OTC and prescription drugs, is expected to grow driven by consumer preferences and regulatory factors.
- Pricing Trends: High costs of prescription drugs are driving consumers towards OTC alternatives, while generics and biosimilars impact branded drug prices.
- Regulatory Impact: FDA approvals, patent expirations, and regulatory policies significantly influence market dynamics and pricing.
- Competitive Landscape: Understanding the market share and competitive positioning of the labeler and other players is crucial for accurate market analysis.
FAQs
Q: What is the National Drug Code (NDC) and its significance?
A: The NDC is a unique, three-segment number that identifies drug products. It consists of a labeler code, a product code, and a package code, serving as the FDA’s identifier for drugs[3].
Q: How does the high cost of prescription drugs affect the pharmaceutical market?
A: The high cost of prescription drugs leads to a shift towards OTC drugs and generics, as consumers seek more affordable healthcare options[4].
Q: What are the key drivers of the OTC drugs market growth in the U.S.?
A: The key drivers include the high cost of prescription drugs, increased OTC drug approvals, and consumer preference for affordable healthcare alternatives[4].
Q: How do generics and biosimilars impact the pricing of branded prescription drugs?
A: Generics and biosimilars can significantly reduce the prices of branded prescription drugs by introducing competitive, often cheaper alternatives[2].
Q: What role does FDA approval play in the market analysis of pharmaceuticals?
A: FDA approvals are critical as they determine the market entry and pricing of new drugs. They also influence the competitive landscape by allowing new products to enter the market[4].
Sources
- FDA's National Drug Code Directory - FDA
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - Drug Development
- National Drug Code Database Background Information - FDA
- U.S. OTC Drugs Market Forecast Report 2024-2029 - GlobeNewswire
- Quallent Pharmaceuticals Health LLC - List of Drugs - NDC Labeler - FindACode
