Introduction
The drug with the National Drug Code (NDC) 00480-1453 is RISPERIDONE SR INJ 50MG 2ML KIT, a long-acting injectable formulation of the antipsychotic medication risperidone. This analysis will delve into the market context, pricing, and projections for this specific drug product.
Market Context
Patient Population
Risperidone is indicated for the treatment of schizophrenia and bipolar disorder. Research suggests that as many as 7 million Americans suffer from the conditions that this product is intended to treat, indicating a significant potential market[1].
Market Size and Growth
The biopharma market, which includes injectable formulations like risperidone, is projected to grow substantially. The biopharma market size was estimated to be over $400 billion in 2024, with a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. This growth is driven by advancements in technological capabilities, evolving regulatory frameworks, and a shift towards patient-centered care[3].
Pricing and Cost Analysis
Current Pricing
As of the latest available data, the Wholesale Acquisition Cost (WAC) for RISPERIDONE SR INJ 50MG 2ML KIT is $1,062.04 per kit[1].
Price Trends
Pharmaceutical pricing can be influenced by various factors including regulatory changes, market competition, and healthcare policy adjustments. For instance, the prices of specialty drugs like risperidone can fluctuate based on these factors. However, specific price trends for this NDC are not readily available, but it is common for prices of injectable medications to remain stable or increase slightly over time due to their complex manufacturing processes and the need for ongoing research and development.
Regulatory Environment
FDA and State Regulations
The introduction of new drugs, including variations like the long-acting injectable form of risperidone, is subject to stringent regulatory oversight. Companies like Teva Pharmaceuticals must submit detailed reports to regulatory bodies, such as the Vermont Attorney General's Office, providing information on marketing and pricing plans, although some of this information may be withheld due to confidentiality[1].
National Drug Code Directory
The FDA's National Drug Code Directory is a critical resource for tracking drug products, including their pricing and market status. This directory ensures that all drugs, including those with NDC 00480-1453, are properly listed and updated to reflect any changes in their market status or pricing[5].
Clinical Trial and Innovation Impact
Accelerated Clinical Trial Designs
The biopharma and biotech industries are moving towards more innovative and efficient clinical trial designs. This shift could impact the development and pricing of drugs like risperidone by reducing the time and cost associated with bringing new formulations to market. However, the specific impact on the long-acting injectable form of risperidone would depend on ongoing research and development activities[3].
Precision Medicine and AI/ML
The increasing use of precision medicine and AI/ML technologies in drug development could also influence the market for risperidone. These technologies can help in personalizing treatment plans, which might affect the demand and pricing of specific formulations like the long-acting injectable form[3].
Market Projections
Demand and Patient Needs
Given the large patient population suffering from schizophrenia and bipolar disorder, the demand for effective and convenient treatment options like the long-acting injectable form of risperidone is likely to remain strong. This demand, coupled with the growing biopharma market, suggests a stable or increasing market share for this product.
Pricing Projections
While exact price projections are challenging without specific market data, it is reasonable to expect that the price of RISPERIDONE SR INJ 50MG 2ML KIT will either remain stable or see moderate increases. This is due to the ongoing costs associated with research, development, and manufacturing, as well as any potential regulatory or market changes.
Key Takeaways
- Patient Population: The drug treats conditions affecting up to 7 million Americans.
- Market Growth: The biopharma market is projected to grow significantly, driven by technological advancements and regulatory changes.
- Current Pricing: The WAC is $1,062.04 per kit.
- Regulatory Environment: Subject to FDA and state regulations, with detailed reporting requirements.
- Innovation Impact: Accelerated clinical trials and precision medicine could influence future development and pricing.
- Market Projections: Stable or increasing demand and moderate price stability or increases.
FAQs
What is the current Wholesale Acquisition Cost (WAC) for RISPERIDONE SR INJ 50MG 2ML KIT?
The current WAC for RISPERIDONE SR INJ 50MG 2ML KIT is $1,062.04 per kit[1].
How many patients in the U.S. could potentially benefit from this drug?
Research suggests that as many as 7 million Americans suffer from the conditions that this product is indicated to treat[1].
What are the key factors influencing the price of this drug?
The price is influenced by factors such as research and development costs, manufacturing complexities, regulatory changes, and market competition.
How does the FDA's National Drug Code Directory impact the tracking of this drug?
The FDA's National Drug Code Directory ensures that all drugs, including those with NDC 00480-1453, are properly listed and updated to reflect any changes in their market status or pricing[5].
What are the potential impacts of accelerated clinical trial designs on this drug?
Accelerated clinical trial designs could reduce the time and cost associated with bringing new formulations to market, potentially affecting the development and pricing of the long-acting injectable form of risperidone[3].
Sources
- Vermont Attorney General's Office, "New Drug Introduction Report Pursuant to 18 V.S.A. § 4637(c)".
- Missouri Department of Social Services, "MISSOURI SPECIALTY MAC NAME OF DRUG".
- TFS CRO, "5 Predictions for the Biopharma and Biotech Industries in 2025".
- Drug Patent Watch, "Latest pharmaceutical drug prices and trends for NDC 50419-0390".
- FDA, "National Drug Code Directory".
