Overview of Fentanyl Citrate Injection
Fentanyl Citrate Injection, identified by the NDC code 63323-806, is a potent opioid analgesic used for the management of acute pain in patients who are tolerant to opioid analgesics. It is classified as a Schedule II controlled substance due to its high potential for abuse and dependence[1].
Market Dynamics
Demand and Supply
The demand for Fentanyl Citrate Injection is driven by the need for effective pain management in clinical settings. However, the supply chain for this drug, like many others, can be affected by various factors such as manufacturing disruptions, regulatory changes, and global health crises like the COVID-19 pandemic. The FDA closely monitors drug shortages, which can significantly impact the availability and pricing of critical medications[5].
Regulatory Environment
The pharmaceutical industry, including drugs like Fentanyl Citrate Injection, is heavily regulated. Changes in regulatory requirements, such as the proposed revision to the National Drug Code (NDC) format, can impact the entire supply chain. The FDA's proposal to switch to a 12-digit NDC format aims to ensure a uniform and consistent coding system, which could influence how drugs are tracked and managed[4].
Price Transparency and Trends
Price Increases and Transparency
The prices of prescription drugs, including Fentanyl Citrate Injection, are influenced by multiple factors within the pharmaceutical supply chain. The Oregon Prescription Drug Price Transparency Program highlights the complexity of drug pricing, with significant price increases reported for various drugs. For instance, the median price increase for generic drugs was 19.9% in 2022, while brand-name drugs saw a median increase of 13.4%[2].
Specific Pricing for Fentanyl Citrate Injection
As of the latest available data, the pricing for Fentanyl Citrate Injection is not explicitly mentioned in the sources provided. However, it is part of a broader opioid market that is subject to strict regulatory oversight and pricing pressures. Given its classification as a Schedule II drug, any price changes would need to be carefully monitored to prevent misuse and ensure affordability.
Factors Influencing Pricing
Manufacturer and Supply Chain Costs
The cost of producing Fentanyl Citrate Injection, including raw materials, manufacturing processes, and distribution, plays a significant role in its pricing. Additionally, rebates, discounts, and other financial negotiations between pharmaceutical companies, pharmacy benefit managers (PBMs), and insurers can significantly impact the final cost to consumers[2].
Regulatory and Policy Changes
Policy initiatives, such as the creation of drug affordability boards and the implementation of upper payment limits, can influence drug prices. For example, Oregon's Prescription Drug Price Transparency Program and the federal Inflation Reduction Act of 2022 aim to increase transparency and control costs in the pharmaceutical market[2].
Price Projections
Short-Term Projections
In the short term, the price of Fentanyl Citrate Injection is likely to remain stable or see moderate increases due to ongoing regulatory and market pressures. However, any significant disruptions in the supply chain or changes in regulatory policies could lead to price volatility.
Long-Term Projections
Long-term price projections are more uncertain and depend on several factors:
- Regulatory Changes: Implementations of upper payment limits or bulk purchasing models could reduce costs.
- Market Competition: Increased competition from generic versions or alternative pain management options could drive prices down.
- Supply Chain Stability: Continued stability in the supply chain, aided by regulatory measures to prevent shortages, would help maintain predictable pricing.
Key Takeaways
- Regulatory Oversight: Fentanyl Citrate Injection is subject to strict regulatory controls due to its potential for abuse.
- Supply Chain Impact: The COVID-19 pandemic and other disruptions can affect the availability and pricing of the drug.
- Price Transparency: Initiatives like the Oregon Prescription Drug Price Transparency Program aim to increase transparency in drug pricing.
- Policy Influences: Changes in regulatory policies and the implementation of affordability measures can impact drug prices.
- Market Dynamics: Demand for effective pain management and supply chain stability are crucial for stable pricing.
FAQs
Q: What is the current regulatory status of Fentanyl Citrate Injection?
A: Fentanyl Citrate Injection is classified as a Schedule II controlled substance and is subject to an Abbreviated New Drug Application (ANDA)[1].
Q: How does the COVID-19 pandemic affect the supply of Fentanyl Citrate Injection?
A: The pandemic has led to supply disruptions and shortages of drug products, including Fentanyl Citrate Injection, due to its impact on the medical product supply chain[5].
Q: What are the key factors influencing the price of Fentanyl Citrate Injection?
A: The price is influenced by manufacturing costs, supply chain dynamics, regulatory policies, and financial negotiations between pharmaceutical companies and PBMs[2].
Q: Are there any proposed changes to the National Drug Code (NDC) format that could affect Fentanyl Citrate Injection?
A: Yes, the FDA has proposed a change to a 12-digit NDC format to ensure a uniform and consistent coding system, which could impact how drugs are tracked and managed[4].
Q: How do policy initiatives like drug affordability boards impact the pricing of Fentanyl Citrate Injection?
A: These initiatives aim to increase transparency and control costs by setting upper payment limits and leveraging bulk purchasing models, which could reduce the cost of the drug[2].
Sources
- DailyMed: FENTANYL CITRATE injection, solution - DailyMed.
- Oregon Health Authority: Prescription Drug Price Transparency Results and Recommendations.
- CMS: Draft Prescription Drug (RXCUIs) to HHS Drug Classes (RXCs).
- FDA: Proposed Rule on Revising the National Drug Code Format.
- FDA: Drug Shortages CY 2023.
