Introduction
The National Drug Code (NDC) 0480-1232 corresponds to Risperidone for Extended-Release Injectable Suspension, a product manufactured by Teva Pharmaceuticals, Inc. This article will delve into the market analysis and price projections for this specific drug, considering various factors such as regulatory frameworks, market trends, and international price comparisons.
Understanding the NDC
The NDC 0480-1232 is part of the unique identifier system used by the FDA to track and regulate drug products. This 10-digit code is segmented into three parts: the labeler code, product code, and package code. For the NDC 0480-1232, the labeler code is 0480, indicating Teva Pharmaceuticals, Inc., the product code identifies the specific strength and formulation of Risperidone, and the package code specifies the package size and type[1][2].
Market Size and Growth
The biopharmaceutical and biotech industries, which include psychiatric medications like Risperidone, are experiencing significant growth. As of 2024, the biopharma market size was estimated to be over $400 billion, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029. The biotech sector is also growing rapidly, with a market size of nearly $500 billion in 2020 and an estimated CAGR of 9.4% between 2021 and 2027[3].
Regulatory Landscape
The regulatory landscape for pharmaceuticals is evolving, with the FDA proposing changes to the NDC format to standardize and simplify the system. The proposed rule would expand NDCs from 10 digits to 12 digits, aiming to minimize confusion and medication errors. This change is expected to have a 3-year transition period, allowing firms to adjust their labeling and systems accordingly[2].
Price Comparisons
Prescription drug prices in the United States are significantly higher compared to other high-income countries. For brand-name drugs, U.S. prices are approximately 422% of prices in comparison countries. However, generic drugs, which account for 90% of U.S. prescription volume, are generally cheaper, with prices averaging 67% of those in comparison countries[4].
Price Projections for Risperidone
Given the current market and regulatory environment, here are some key points to consider for price projections of Risperidone (NDC 0480-1232):
Current Pricing
As of the latest data, Risperidone prices in the U.S. are higher compared to other OECD countries. For instance, brand-name psychiatric medications, including extended-release injectable suspensions like Risperidone, tend to have higher price indexes in the U.S.[4].
Impact of Regulatory Changes
The proposed FDA rule to standardize NDCs to a 12-digit format may have indirect effects on pricing by reducing administrative and labeling costs. However, this is unlikely to significantly impact the pricing of Risperidone directly[2].
Market Competition
The presence of generic versions of Risperidone can influence pricing. Generic drugs are generally cheaper, and their availability can drive down the prices of brand-name and extended-release formulations. However, the extended-release injectable suspension of Risperidone, being a specialized formulation, may maintain a premium price due to its unique delivery mechanism and therapeutic benefits[5].
International Price Comparisons
International price comparisons indicate that the U.S. market tends to have higher prices for brand-name drugs. This trend is expected to continue, although there may be some adjustments due to rebates and discounts applied to manufacturer prices. For Risperidone, this means that prices in the U.S. are likely to remain higher than in many other countries[4].
Key Takeaways
- Market Growth: The biopharmaceutical and biotech industries are growing rapidly, driven by technological advancements and evolving regulatory frameworks.
- Regulatory Changes: The FDA's proposed rule to standardize NDCs to 12 digits may streamline administrative processes but is unlikely to directly impact drug pricing.
- Price Comparisons: U.S. prices for brand-name drugs, including Risperidone, are significantly higher than in other OECD countries.
- Market Competition: The availability of generic versions can influence pricing, but specialized formulations like the extended-release injectable suspension of Risperidone may maintain premium prices.
FAQs
1. What is the significance of the NDC 0480-1232?
The NDC 0480-1232 is a unique identifier for Risperidone for Extended-Release Injectable Suspension, manufactured by Teva Pharmaceuticals, Inc. It helps in tracking and regulating the drug product.
2. How does the FDA's proposed NDC format change affect drug pricing?
The proposed change to a 12-digit NDC format is primarily aimed at reducing administrative and labeling costs and minimizing confusion and medication errors. It is unlikely to have a direct significant impact on drug pricing.
3. Why are U.S. prices for Risperidone higher than in other countries?
U.S. prices for brand-name drugs, including Risperidone, are higher due to various factors such as faster growth in U.S. prices, differences in regulatory frameworks, and the absence of price controls seen in many other countries.
4. How does the availability of generic versions affect the price of Risperidone?
The availability of generic versions of Risperidone can drive down prices, but the extended-release injectable suspension, being a specialized formulation, is likely to maintain a premium price.
5. What are the projected market trends for psychiatric medications like Risperidone?
The market for psychiatric medications, including Risperidone, is expected to grow due to increasing demand and advancements in therapeutic treatments. However, pricing will continue to be influenced by regulatory changes, market competition, and international price comparisons.
Sources
- FDA: National Drug Code Database Background Information.
- FDA: Future Format of the National Drug Code.
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025.
- ASPE: International Prescription Drug Price Comparisons: Estimates Using IQVIA MIDAS Data.
- DailyMed: Risperidone kit - Label.
