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Last Updated: January 5, 2025

Drug Price Trends for NDC 00113-0194


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Best Wholesale Price for NDC 00113-0194

These are wholesale prices available to the US Federal Government which, by law, must be the best prices available under comparable terms and conditions
Drug Name Vendor NDC Count Price ($) Price/Unit ($) Dates Price Type
>Drug Name >Vendor >NDC >Count >Price ($) >Price/Unit ($) >Dates >Price Type
Price type key: Federal Supply Schedule (FSS): generally available to all Federal Govt agencies / 'BIG4' prices: VA, DoD, Public Health & Coast Guard only / National Contracts (NC): Available to specific agencies

00113-0194 Market Analysis and Financial Projection

Market Analysis and Price Projections for the Drug NDC: 00113-0194

Introduction to National Drug Codes (NDCs)

The National Drug Code (NDC) is a unique, three-segment number assigned by the FDA to identify drugs in the U.S. market. For the NDC 00113-0194, understanding the NDC system, market trends, and pricing mechanisms is crucial for accurate market analysis and price projections.

Understanding the NDC Directory

The FDA's NDC Directory is a comprehensive resource that contains information on all listed drugs in their final marketed form, including prescription, over-the-counter, approved, and unapproved drugs. This directory is updated daily and includes data elements such as the Drug Enforcement Administration schedule and pharmacological class[1][5].

Market Trends in the Pharmaceutical Industry

The U.S. pharmaceutical market is projected to grow significantly, from $846.72 billion in 2022 to $1.28 trillion by 2030, with a compound annual growth rate (CAGR) of 5.36%. This growth is driven by factors such as rising pharmaceutical production capacity, greater approvals of generic drugs, and escalating R&D investments[2].

Small Molecule Drugs vs. Biologics

While small molecule drugs still dominate the market, biologic products are experiencing rapid growth. In the U.S., sales revenues for biologic products grew by 61% between 2017 and 2022, in contrast to a 4% growth for small molecule drugs. This shift indicates a market trend towards more complex and often higher-priced biologic therapies[4].

Pricing Mechanisms in the Pharmaceutical Market

Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)

For drugs covered under the Medicaid Drug Rebate Program, the 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure. This price is then adjusted by the package size and case pack size to determine the final ceiling price[2].

Example Calculation

If the NDC 00113-0194 corresponds to a drug covered under the Medicaid program, the ceiling price would be calculated as follows:

  • AMP: Average Manufacturer Price per unit
  • URA: Unit Rebate Amount per unit
  • Package Size: Number of units per package
  • Case Pack Size: Number of packages per case

[ \text{340B Ceiling Price} = (\text{AMP} - \text{URA}) \times \text{Package Size} \times \text{Case Pack Size} ]

For instance:

  • AMP: $100 per unit
  • URA: $20 per unit
  • Package Size: 10 units
  • Case Pack Size: 5 packages

[ \text{340B Ceiling Price} = (100 - 20) \times 10 \times 5 = \$4000 ]

Factors Influencing Price Projections

Historical Pricing Data

Reviewing historical pricing data from the NDC Directory and other sources provides insights into price trends and potential future adjustments. This data can help predict whether the price of the drug with NDC 00113-0194 is likely to increase, decrease, or remain stable[2].

Regulatory Changes

Changes in regulatory policies, such as updates to the Medicaid Drug Rebate Program or new FDA guidelines, can significantly impact pricing. For example, changes in the FDA's approval process or new regulations on drug pricing could affect the market price of the drug[2].

Market Demand and Competition

The demand for the drug and the level of competition in the market are critical factors. If the drug faces significant competition from generics or biosimilars, the price might be more stable or even decrease over time. Conversely, if the drug has a unique therapeutic benefit and limited competition, prices could remain high or increase[2].

Technological Advancements

The adoption of AI and other technological advancements can reduce development and manufacturing costs, potentially leading to lower prices. However, these advancements can also lead to the development of more complex and expensive therapies, depending on the specific application[2][3].

Market Size and Growth Projections

The U.S. pharmaceutical market is expected to continue its growth trajectory, driven by increasing demand for pharmaceuticals, advancements in technology, and a shift towards personalized medicine. The biopharma and biotech sectors, in particular, are experiencing rapid growth, with the biopharma market projected to grow at a CAGR of 7.56% between 2024 and 2029[3].

Example: Pricing for a Specific NDC

If the NDC 00113-0194 corresponds to a widely used drug with high demand but significant competition from generics or biosimilars, here is a hypothetical example:

  • AMP: $80 per unit
  • URA: $15 per unit
  • Package Size: 20 units
  • Case Pack Size: 3 packages

[ \text{340B Ceiling Price} = (80 - 15) \times 20 \times 3 = \$5850 ]

This calculation provides a baseline for the ceiling price, but actual market prices can vary based on various factors including market demand, competition, and regulatory changes.

Precision Medicine and AI/ML Technologies

The future of pharmaceutical pricing will be influenced by the increasing use of precision medicine and AI/ML technologies. These advancements are expected to make drug development more efficient and personalized, potentially leading to higher efficacy and lower long-term costs. However, the initial investment in these technologies could result in higher prices for new drugs[3].

Regulatory Landscape

The regulatory landscape is evolving to keep pace with innovation. Changes in FDA guidelines and regulatory policies can impact the pricing and availability of drugs. For instance, new regulations on drug pricing transparency or changes in the approval process for generic and biosimilar drugs can significantly affect market prices[3].

Key Takeaways

  • NDC Directory: A critical resource for tracking and pricing drugs, updated daily by the FDA.
  • Market Trends: The U.S. pharmaceutical market is growing, with biologics and biosimilars experiencing rapid growth.
  • Pricing Mechanisms: AMP and URA are key in calculating ceiling prices for covered outpatient drugs.
  • Market Growth: The U.S. pharmaceutical market is projected to grow significantly by 2030.
  • Price Projections: Historical data, regulatory changes, market demand, and technological advancements influence price projections.

FAQs

Q: What is the National Drug Code (NDC) and how is it used? A: The NDC is a unique three-segment number assigned by the FDA to identify drugs in the U.S. market. It is used for tracking, pricing, and regulatory compliance of pharmaceutical products.

Q: How is the 340B ceiling price calculated? A: The 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure, then adjusting by the package size and case pack size.

Q: What factors influence price projections for pharmaceuticals? A: Historical pricing data, regulatory changes, market demand, competition, and technological advancements influence price projections.

Q: How does the adoption of AI and other technological advancements impact drug pricing? A: The adoption of AI and other technological advancements can reduce development and manufacturing costs, potentially leading to lower prices, but can also lead to the development of more complex and expensive therapies.

Q: What is the projected growth rate of the U.S. pharmaceutical market? A: The U.S. pharmaceutical market is projected to grow from $846.72 billion in 2022 to $1.28 trillion by 2030, with a CAGR of 5.36%.

Sources

  1. YouTube - NDC Directory (March 2015)
  2. DrugPatentWatch - Market Analysis and Financial Projection Experimental
  3. TFS CRO - 5 Predictions for the Biopharma and Biotech Industries in 2025
  4. ASPE - ISSUE BRIEF: International Market Size and Prices
  5. FDA - National Drug Code Directory

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