Introduction to NDC 70677-0087
The National Drug Code (NDC) 70677-0087 identifies a specific pharmaceutical product, which in this case is likely a formulation of Fexofenadine Hydrochloride, given the similarity in NDC codes to other Fexofenadine products[1].
Understanding the NDC System
The NDC is a unique, three-segment number that identifies a drug product. It includes the labeler code, product code, and package code. This system is crucial for tracking and regulating drug products in the U.S.[4].
Market Context of Generic Drugs
The pharmaceutical industry, particularly the generic drug sector, is experiencing several trends that impact pricing and market dynamics. Here are some key points:
- Price Erosion: The generic drug industry is expected to see mid-single-digit percent annual price erosion in 2024. This is a common trend due to the competitive nature of the market[3].
- Revenue Growth: Despite price erosion, there is a projected return to modest revenue growth, which is an improvement from recent years. Biosimilars are also expected to see substantial revenue growth, although intense competition may limit profitability[3].
- Regulatory Risks: The industry faces potential risks such as price-fixing litigation and increased FDA inspections of foreign manufacturing facilities, which could impact pricing and availability[3].
Pricing Mechanisms
Average Manufacturer Price (AMP) and Unit Rebate Amount (URA)
For drugs covered under the Medicaid Drug Rebate Program, the 340B ceiling price is calculated by subtracting the URA from the AMP for the smallest unit of measure. This price is then adjusted by the package size and case pack size to determine the final ceiling price[2].
Wholesale Pricing
Wholesale prices for generic drugs can fluctuate based on market conditions. For example, the NADAC (National Average Drug Acquisition Cost) wholesale price for similar products can vary significantly over time, reflecting changes in supply and demand[5].
Price Projections for NDC 70677-0087
Given the trends in the generic drug market:
- Short-Term Projections: In the short term, prices for NDC 70677-0087 are likely to follow the general trend of mid-single-digit percent annual price erosion. This means that the price could decrease by around 3-5% annually.
- Long-Term Projections: Over the long term, while there may be modest revenue growth for the generic drug industry, intense competition and regulatory pressures could keep prices relatively stable or slightly decreasing.
Factors Influencing Pricing
Competition
The generic drug market is highly competitive, which drives prices down. Multiple manufacturers producing the same or similar products contribute to this competitive environment[3].
Regulatory Changes
Changes in FDA regulations, such as increased inspections of foreign manufacturing facilities, can impact the supply chain and pricing. Additionally, price-fixing litigation can lead to price volatility[3].
Market Demand
Fluctuations in demand due to seasonal variations (e.g., allergy seasons for antihistamines like Fexofenadine) can also influence pricing.
Manufacturer and Distributor Dynamics
- Labeler Information: The labeler for NDC 70677-0087, likely Sunmark or a similar entity, plays a crucial role in setting the initial price based on their production costs, market conditions, and regulatory requirements[1].
- Distribution Channels: The price at which the drug is sold to pharmacies and other distributors can be influenced by the labeler's agreements and the distribution network.
Conclusion
The market analysis and price projections for NDC 70677-0087 suggest that prices will likely follow the broader trends in the generic drug industry. Here are the key takeaways:
- Price Erosion: Expect mid-single-digit percent annual price erosion.
- Modest Revenue Growth: Despite price erosion, the industry may see modest revenue growth.
- Regulatory Risks: Be aware of potential risks from regulatory changes and litigation.
- Competitive Market: The highly competitive nature of the generic drug market will continue to influence pricing.
Key Takeaways
- Price Trends: Prices for NDC 70677-0087 are expected to decrease by around 3-5% annually.
- Revenue Growth: The generic drug industry may see modest revenue growth despite price erosion.
- Regulatory Impact: Regulatory changes and litigation can impact pricing and availability.
- Market Competition: High competition in the generic drug market drives prices down.
- Demand Fluctuations: Seasonal demand variations can influence pricing.
FAQs
Q: What is the NDC 70677-0087 used for?
A: NDC 70677-0087 is likely used for Fexofenadine Hydrochloride, an antihistamine commonly used to treat allergies.
Q: How is the 340B ceiling price calculated?
A: The 340B ceiling price is calculated by subtracting the Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure, then adjusting for package size and case pack size[2].
Q: What are the main factors influencing the price of generic drugs?
A: The main factors include competition, regulatory changes, and market demand.
Q: How does the FDA regulate drug pricing?
A: The FDA does not directly regulate drug pricing but ensures compliance with pricing formulas under programs like the Medicaid Drug Rebate Program[2].
Q: What are the potential risks for the generic drug industry in 2024?
A: Potential risks include price-fixing litigation and increased FDA inspections of foreign manufacturing facilities[3].
