Introduction
The National Drug Code (NDC) 00378-9122 corresponds to the Fentanyl transdermal system, a prescription drug used for the management of severe and persistent pain in opioid-tolerant patients. This analysis will delve into the market dynamics, pricing trends, and potential future projections for this drug.
Drug Overview
The Fentanyl transdermal system, with the NDC 00378-9122, is manufactured by Mylan Pharmaceuticals Inc. and is classified as a Human Prescription Drug under the DEA Schedule CII[4].
Market Context
The pharmaceutical market, particularly for prescription drugs, is subject to various factors that influence pricing and demand.
Regulatory Environment
The FDA's National Drug Code Database plays a crucial role in identifying and tracking drug products, including the Fentanyl transdermal system. Each drug product is assigned a unique 10-digit NDC number, which helps in monitoring and regulating the market[1].
Pricing Trends
Prescription drug prices have been a subject of significant scrutiny due to their impact on affordability and healthcare costs. From 2017 to 2023, there has been a notable trend of price increases for prescription drugs. For instance, between January 2022 and January 2023, more than 4,200 drug products experienced price increases, with an average increase of 15.2%[2].
Price Increases and Affordability
The Fentanyl transdermal system, like many other prescription drugs, is not immune to price fluctuations.
Historical Price Changes
While specific historical price data for NDC 00378-9122 is not provided, the broader trend indicates that prescription drugs, especially those in high demand or with limited competition, are prone to significant price increases. For example, generic drugs have seen substantial price hikes, with some increases as high as 2,527% over several years[5].
Impact on Affordability
High prescription drug prices create affordability challenges for patients, healthcare payers, employers, and taxpayers. The average price increase of 15.2% from January 2022 to January 2023 translates to a significant dollar value increase, exacerbating these challenges[2].
Market Projections
Industry Predictions
Looking ahead to 2025, several trends are expected to shape the pharmaceutical market:
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AI and Data Trends: The adoption of artificial intelligence (AI) in clinical development and drug discovery is expected to increase. This could lead to more efficient drug development processes and potentially influence pricing through reduced development costs[3].
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Price Transparency: Efforts to enhance price transparency, such as the Prescription Drug Price Transparency program, may lead to more informed decision-making and potentially stabilize or reduce price increases[5].
Potential Price Projections
Given the historical trends and future predictions:
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Short-Term Projections: In the short term, it is likely that the Fentanyl transdermal system will experience price increases, although the magnitude may vary. The average price increase for prescription drugs has been around 15%, so a similar or slightly lower increase could be anticipated for NDC 00378-9122.
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Long-Term Projections: In the long term, the impact of AI and increased price transparency could lead to more stable or even reduced prices. However, this would depend on various factors, including market competition, regulatory changes, and the overall economic environment.
Key Takeaways
- Regulatory Oversight: The FDA's NDC system ensures that each drug product, including the Fentanyl transdermal system, is uniquely identified and tracked.
- Pricing Trends: Prescription drugs, including the Fentanyl transdermal system, have seen significant price increases in recent years.
- Affordability Challenges: High prices create affordability issues for various stakeholders.
- Future Trends: AI adoption and price transparency efforts may influence future pricing dynamics.
FAQs
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What is the NDC code for the Fentanyl transdermal system?
- The NDC code for the Fentanyl transdermal system is 00378-9122[4].
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Why do prescription drug prices increase?
- Prescription drug prices can increase due to various factors, including market demand, production costs, and regulatory changes[2].
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How does AI impact the pharmaceutical industry?
- AI is expected to enhance clinical development, drug discovery, and price transparency, potentially stabilizing or reducing prices in the long term[3].
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What is the DEA schedule for the Fentanyl transdermal system?
- The Fentanyl transdermal system is classified under DEA Schedule CII[4].
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How does price transparency affect prescription drug pricing?
- Price transparency programs aim to provide more detailed information about price changes, which can lead to more informed decision-making and potentially stabilize or reduce price increases[5].
Sources
- National Drug Code Database Background Information - FDA
- Changes in the List Prices of Prescription Drugs, 2017-2023 - ASPE
- 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch - Intelligencia AI
- FENTANYL patch - DailyMed
- Prescription Drug Price Transparency Results and Recommendations - Oregon Department of Consumer and Business Services
