Introduction
The Fentanyl Transdermal Patch, identified by the National Drug Code (NDC) 0378-9123, is a prescription drug used for managing chronic pain in patients who require continuous, long-term opioid therapy. Here, we will delve into the market analysis and price projections for this drug.
Product Overview
- Generic Name: Fentanyl
- Dosage Form: Transdermal Patch
- Route of Administration: Transdermal
- Active Ingredient Strength: 75 μg/h
- Labeler Name: Mylan Pharmaceuticals Inc.
- Marketing Start Date: January 31, 2005[1].
Market Context
The pharmaceutical market, particularly for opioid medications, is subject to various factors that influence pricing and demand.
Biopharma and Biotech Market Trends
The biopharma and biotech industries are experiencing significant growth, driven by technological advancements, evolving regulatory frameworks, and a shift towards patient-centered care. However, these trends primarily impact newer, innovative drugs rather than established products like fentanyl patches[3].
Prescription Drug Price Trends
Recent years have seen substantial increases in prescription drug prices. From January 2022 to January 2023, more than 4,200 drug products experienced price increases, with an average increase of 15.2% or $590 per drug product. This trend is particularly pronounced for multi-source drugs, which saw an average price increase of 26.0% during the same period[2].
Price Projections
Given the broader trends in prescription drug pricing:
Historical Price Increases
Fentanyl patches, as part of the opioid class, have likely been subject to price increases over the years. However, specific historical data for NDC 0378-9123 is not readily available. Generally, opioid prices have been influenced by factors such as regulatory changes, market demand, and competition from generic or alternative treatments.
Future Price Trends
- Inflation and Market Adjustments: Prices for prescription drugs, including fentanyl patches, are expected to continue rising, albeit potentially at a rate that may be influenced by inflation and regulatory pressures. The average price increase for multi-source drugs, which includes generics and branded generics like Mylan's fentanyl patch, was 26.0% from January 2022 to January 2023[2].
- Competition and Generic Market: The presence of generic versions of fentanyl patches can mitigate price increases to some extent. However, the absolute dollar increases tend to be smaller for multi-source drugs compared to single-source drugs[2].
Market Drivers and Challenges
Demand and Patient Needs
The demand for fentanyl patches is driven by the need for effective chronic pain management. However, the opioid crisis has led to increased scrutiny and regulatory oversight, which can impact prescribing patterns and patient access.
Regulatory Landscape
Regulatory changes and safety measures imposed by health authorities can affect the pricing and availability of opioid medications. For instance, stricter prescribing guidelines and monitoring programs may reduce demand or increase costs associated with compliance[3].
Competitive Landscape
Generic Competition
The fentanyl patch market includes both branded and generic versions. Mylan's product, while being a generic, competes with other generic and branded fentanyl patches. This competition can help stabilize prices but may also lead to periodic price adjustments based on market dynamics.
Alternative Treatments
The rise of alternative pain management therapies, including non-opioid medications and interventional procedures, can also influence the demand for fentanyl patches and subsequently impact pricing.
Unmet Needs and Future Outlook
Patient-Centered Care
The shift towards patient-centered care and precision medicine may lead to more tailored treatment options, potentially reducing the reliance on broad-spectrum opioids like fentanyl. However, for patients requiring continuous opioid therapy, fentanyl patches will likely remain a viable option.
Technological Advancements
Advancements in drug delivery systems and pain management technologies could introduce new competitors or alternatives to traditional fentanyl patches, influencing future price trends.
Key Takeaways
- Price Increases: Fentanyl patches are likely to experience price increases, though the rate may vary based on market and regulatory factors.
- Competition: Generic competition and alternative treatments can influence pricing dynamics.
- Regulatory Impact: Regulatory changes and safety measures will continue to shape the market for opioid medications.
- Patient Needs: The ongoing need for effective chronic pain management will sustain demand for fentanyl patches.
FAQs
-
What is the NDC for the Fentanyl Transdermal Patch by Mylan?
- The NDC for the Fentanyl Transdermal Patch by Mylan is 0378-9123[1].
-
What is the active ingredient strength of this fentanyl patch?
- The active ingredient strength is 75 μg/h[1].
-
How have prescription drug prices changed recently?
- From January 2022 to January 2023, prescription drug prices saw an average increase of 15.2% or $590 per drug product[2].
-
What factors influence the pricing of fentanyl patches?
- Factors include regulatory changes, market demand, competition from generics or alternative treatments, and broader economic trends such as inflation[2].
-
How does the competitive landscape affect the pricing of fentanyl patches?
- The presence of generic and branded competitors, as well as alternative pain management therapies, can stabilize or reduce prices but may also lead to periodic price adjustments based on market dynamics.
Sources
- FDA.report: NDC 0378-9123 Transdermal Patch FENTANYL Drug.
- ASPE: Changes in the List Prices of Prescription Drugs, 2017-2023.
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025.
- GlobalData: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
- FDA: National Drug Code Database Background Information.
