Introduction to NDC 24510-0075
NDC 24510-0075 corresponds to a specific formulation of the drug XTAMPZA ER, which is an extended-release oral capsule containing oxycodone. This drug is labeled and distributed by Collegium Pharmaceutical, Inc.[1].
Market Context: Opioid Market
The opioid market, particularly for extended-release formulations, is subject to stringent regulations and evolving market dynamics. Here are some key points to consider:
Regulatory Environment
The FDA and other regulatory bodies closely monitor opioid products due to their potential for abuse and misuse. This scrutiny can impact pricing and market access. For instance, the FDA's National Drug Code (NDC) Directory ensures that all drugs, including opioids, are properly identified and reported[5].
Market Trends
The opioid market is influenced by various factors, including changes in prescribing practices, regulatory policies, and the introduction of alternative pain management options. The shift towards safer, more controlled-release formulations like XTAMPZA ER is a significant trend.
Price Projections and Market Analysis
Current Market Position
XTAMPZA ER, with the NDC 24510-0075, is a controlled-release opioid, which places it in a highly regulated segment of the pharmaceutical market. The price of such drugs is influenced by factors such as production costs, regulatory compliance, and market demand.
Pricing Mechanisms
Pricing for prescription drugs, including opioids, involves complex calculations that include the Average Manufacturer Price (AMP) and the Best Price, which are critical for Medicaid and other government programs. Manufacturers must report these prices accurately to comply with regulatory requirements[2].
Competitive Landscape
The opioid market is competitive, with several players offering various formulations. However, the extended-release segment, where XTAMPZA ER operates, is particularly competitive due to the need for controlled-release mechanisms to mitigate abuse potential.
Forecasting Price Trends
Regulatory Impact
Regulatory changes, such as those related to warranty payment arrangements and value-based pricing (VBP) models, can affect the pricing strategy of pharmaceutical companies. For example, warranty arrangements where manufacturers pay premiums to ensure certain clinical outcomes can reduce the drug's price but must be included in the best price calculations[2].
Market Growth and Competition
The overall opioid market is expected to see fluctuations due to changing prescribing practices and the introduction of new pain management therapies. However, extended-release opioids like XTAMPZA ER are likely to maintain a stable market share due to their controlled-release mechanism.
Economic Factors
Economic factors such as production costs, distribution expenses, and reimbursement policies also play a crucial role in determining the price of XTAMPZA ER. Any changes in these factors can lead to price adjustments.
Statistical Insights
While specific price projections for NDC 24510-0075 are not readily available, we can look at broader trends in the opioid market:
- Opioid Sales: The opioid market has seen a decline in recent years due to increased regulatory scrutiny and changes in prescribing practices.
- Extended-Release Formulations: These formulations, like XTAMPZA ER, are expected to maintain a stable market presence due to their safety profile and controlled-release mechanism.
Expert Predictions and Industry Trends
Adoption of AI and Health Tech
The pharmaceutical industry is increasingly adopting artificial intelligence (AI) and health tech to improve drug development and market analysis. This trend could influence pricing strategies by providing more accurate market forecasts and optimizing production costs[3].
Data-Driven Decision Making
The use of large language models (LLMs) and other AI tools is expected to grow, helping pharmaceutical companies make more informed decisions about pricing and market positioning[3].
Unmet Needs and Future Outlook
Patient Needs
The opioid market is driven by patient needs for effective pain management. As healthcare providers and patients seek safer alternatives, the demand for controlled-release opioids like XTAMPZA ER is likely to remain steady.
Innovation and Competition
The future outlook for XTAMPZA ER will depend on innovations in pain management and the competitive landscape. New entrants and alternative therapies could impact market share and pricing.
Key Takeaways
- Regulatory Compliance: Pricing for XTAMPZA ER is heavily influenced by regulatory requirements, including accurate reporting of AMP and Best Price.
- Market Trends: The opioid market is subject to changes in prescribing practices and regulatory policies.
- Competitive Landscape: The extended-release opioid segment is competitive, with a focus on safety and controlled-release mechanisms.
- Economic Factors: Production costs, distribution expenses, and reimbursement policies are crucial in determining the price of XTAMPZA ER.
- Technological Advancements: The adoption of AI and health tech is expected to improve market analysis and pricing strategies.
FAQs
Q: What is the NDC 24510-0075, and what does it correspond to?
A: NDC 24510-0075 corresponds to XTAMPZA ER, an extended-release oral capsule containing oxycodone, distributed by Collegium Pharmaceutical, Inc.
Q: How does the regulatory environment impact the pricing of opioids like XTAMPZA ER?
A: The regulatory environment, including FDA guidelines and reporting requirements, significantly influences the pricing of opioids by ensuring compliance with AMP and Best Price calculations.
Q: What role does AI and health tech play in the pharmaceutical industry, particularly in pricing strategies?
A: AI and health tech are increasingly used to improve market analysis, optimize production costs, and make informed pricing decisions.
Q: How does the competitive landscape affect the price of XTAMPZA ER?
A: The competitive landscape, particularly in the extended-release opioid segment, influences pricing due to the need for safety and controlled-release mechanisms.
Q: What are the key economic factors that determine the price of XTAMPZA ER?
A: Key economic factors include production costs, distribution expenses, and reimbursement policies.
Sources
- FDA Report: NDC 24510-115 Oral Capsule, Extended Release XTAMPZA ER...
- Medicaid: Manufacturer Release 118 - Medicaid
- Intelligencia.ai: 2025 Pharma Predictions: AI, Health Tech, and Data Trends to Watch
- Drug-Dev: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025
- FDA: National Drug Code Directory - FDA
