Introduction
Fentanyl Citrate Injection, with the NDC code 00641-6027, is a critical medication in the opioid class, used primarily for pain management. This analysis will delve into the current market dynamics, pricing trends, and future projections for this drug.
Market Overview
Drug Description and Usage
Fentanyl Citrate Injection is a preservative-free solution available in various volumes, including 2 mL, 5 mL, and 20 mL, each containing 50 mcg of fentanyl base per mL. It is classified as a Schedule II controlled substance due to its high potential for abuse and dependence[1].
Current Market Status
The pharmaceutical market, particularly for opioids like fentanyl, is complex and influenced by several factors including regulatory policies, supply and demand, and global health trends. The U.S. market for prescription drugs has seen significant growth, with sales revenues increasing by 22% between 2017 and 2022, far outpacing other regions[4].
Pricing Trends
Historical Pricing
The pricing of Fentanyl Citrate Injection has been subject to various market forces. In the U.S., the average price per unit of prescription drugs has increased by 14% between 2017 and 2022, which is significantly higher than in other OECD countries and the rest of the world[4].
Current Pricing
As of the latest data, there is no specific pricing information available for the NDC 00641-6027. However, it is known that drug prices in the U.S. are generally higher compared to other countries. For instance, the average price per unit in the U.S. is 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world[4].
Supply and Demand Issues
Drug Shortages
Fentanyl Citrate Injection has been experiencing shortages due to several reasons, including supply and demand issues and the cessation of operations by certain manufacturers like Akorn. Hikma Pharmaceuticals, one of the primary manufacturers, has reported shortages due to these issues, with some products on back order and uncertain resupply dates[5].
Regulatory Environment
DEA Scheduling
As a Schedule II controlled substance, Fentanyl Citrate Injection is subject to strict regulatory oversight. This classification affects its distribution, prescribing, and pricing, as it must comply with stringent DEA regulations[1].
Future Projections
Market Growth
The pharmaceutical industry is expected to continue growing, driven by advancements in technology, increased demand for healthcare services, and the integration of artificial intelligence (AI) in drug development and clinical operations. AI is predicted to play a more significant role in 2025, with increased adoption in standard operations and the use of external data to train internal data science models[3].
Pricing Projections
Given the historical trend of increasing drug prices in the U.S., it is likely that the price of Fentanyl Citrate Injection will continue to rise. However, the rate of increase may be influenced by regulatory actions, changes in supply and demand, and the overall economic conditions.
Impact of AI and Health Tech
The use of AI and health tech is expected to improve efficiency and reduce costs in the long run, but in the short term, these technologies may also contribute to higher development and operational costs, potentially affecting drug prices. For example, the use of large language models (LLMs) and expert AI applications could enhance decision-making but may also increase the cost of drug development[3].
Key Takeaways
- Market Growth: The pharmaceutical market, including opioids like Fentanyl Citrate Injection, is expected to grow driven by technological advancements and increased healthcare demand.
- Pricing Trends: Prices for prescription drugs in the U.S. have historically been higher and are expected to continue rising, influenced by regulatory, supply, and demand factors.
- Supply Issues: Current shortages of Fentanyl Citrate Injection highlight the need for stable supply chains and robust manufacturing capabilities.
- Regulatory Environment: Strict DEA regulations will continue to impact the distribution and pricing of Schedule II controlled substances.
- Technological Impact: The integration of AI and health tech may improve efficiency but could also increase short-term costs.
FAQs
1. What is the current status of Fentanyl Citrate Injection supply?
Fentanyl Citrate Injection is currently experiencing shortages due to supply and demand issues and the cessation of operations by some manufacturers. Hikma Pharmaceuticals has several products on back order with uncertain resupply dates[5].
2. How does the DEA scheduling affect Fentanyl Citrate Injection?
As a Schedule II controlled substance, Fentanyl Citrate Injection is subject to strict DEA regulations, affecting its distribution, prescribing, and pricing[1].
3. What are the predicted trends in pharmaceutical pricing for 2025?
Pharmaceutical prices in the U.S. are expected to continue rising, influenced by regulatory actions, changes in supply and demand, and the integration of AI and health tech[3][4].
4. How will AI impact the pharmaceutical industry in 2025?
AI is expected to increase its presence in standard operations, external data usage, and expert AI applications, potentially improving efficiency but also increasing short-term costs[3].
5. Why are drug prices in the U.S. higher compared to other countries?
Drug prices in the U.S. are higher due to a combination of factors including higher prices per unit, a drug mix that skews towards higher-cost drugs, and different regulatory and market conditions compared to other OECD countries and the rest of the world[4].
Sources
- DailyMed: FENTANYL CITRATE injection - DailyMed
- New York State Department of Financial Services: Drug Price Increases Report - November 2024
- Intelligencia.ai: 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch
- ASPE: ISSUE BRIEF - International Market Size and Prices
- ASHP: Drug Shortage Detail: Fentanyl Citrate Injection
