Introduction
Folic acid, with the National Drug Code (NDC) 11534-165, is a prescription drug distributed by Sunrise Pharmaceutical, Inc. This article provides a comprehensive market analysis and price projections for this specific drug.
Market Overview
Drug Classification and Usage
Folic acid is a human prescription drug categorized under the generic name "Folic Acid" and proprietary name "FOLIC ACID." It is available in oral tablet form, with a strength of 1 mg per tablet[1].
Market Demand
Folic acid is widely used for preventing and treating folate deficiency, particularly in pregnant women to prevent neural tube defects. The demand for folic acid is consistent due to its essential role in public health initiatives and routine medical care.
Competitive Landscape
The market for folic acid is competitive, with multiple manufacturers and distributors. The presence of generic versions, such as the one distributed by Sunrise Pharmaceutical, Inc., contributes to the competitive pricing environment. Other manufacturers also produce folic acid tablets, which can impact pricing dynamics[1][3].
Regulatory Environment
National Drug Code (NDC) and FDA Regulations
The NDC 11534-165 is part of the FDA's National Drug Code Directory, which contains information on finished drug products, including prescription and over-the-counter drugs. The FDA requires drug establishments to update their drug listing data regularly to ensure accuracy and compliance[2][3].
Compliance and Listing
The drug is listed under the Abbreviated New Drug Application (ANDA) category, indicating it has undergone the necessary approval process for generic drugs. This regulatory framework ensures the drug meets safety and efficacy standards set by the FDA[1][3].
Pricing Factors
Manufacturing and Distribution Costs
The cost of producing folic acid tablets includes raw material costs, manufacturing overhead, and distribution expenses. These costs can fluctuate based on market conditions, supply chain disruptions, and economic factors.
Market Competition
The presence of multiple generic versions of folic acid tablets drives competition, which can lead to lower prices. Pharmaceutical companies often engage in competitive pricing strategies to capture market share.
Regulatory Influences
Changes in FDA regulations or policies can impact the pricing of drugs. For example, revisions in the National Drug Code format or changes in reporting requirements can influence operational costs and subsequently affect pricing[2][3].
Price Projections
Current Pricing
As of the latest data, the pricing for folic acid tablets with NDC 11534-165 can vary depending on the pharmacy, location, and insurance coverage. On average, a 30-tablet supply can range from $5 to $15, reflecting the competitive nature of the generic drug market.
Future Trends
Given the stable demand and competitive market, price projections for folic acid tablets are likely to remain relatively stable. Here are some key trends:
- Short-term (2025-2026): Prices are expected to remain stable due to consistent demand and supply. Any significant changes in raw material costs or manufacturing efficiencies could lead to minor price adjustments.
- Medium-term (2027-2030): The market may see slight price reductions as more generic versions enter the market, increasing competition. Regulatory changes, if any, could also impact pricing.
- Long-term (2030 and beyond): The trend of stable to slightly decreasing prices is likely to continue, driven by ongoing competition and potential advancements in manufacturing processes.
Market Analysis Tools
Data Sources
Market analysis for folic acid tablets involves using data from the FDA's National Drug Code Directory, industry reports, and market research databases. Tools like the NDC Express mobile app and the Drug Name and NDC Reference Data can provide up-to-date information on drug listings and market trends[2][4].
Statistical Analysis
Statistical models can be used to forecast demand and price trends. These models consider historical data on sales, market share, and pricing strategies of competitors.
Key Takeaways
- Stable Demand: Folic acid tablets have a consistent demand due to their medical necessity.
- Competitive Market: The presence of multiple generic versions keeps prices competitive.
- Regulatory Compliance: Adherence to FDA regulations is crucial for maintaining market presence.
- Price Stability: Prices are expected to remain stable with potential for slight reductions in the medium to long term.
FAQs
Q: What is the primary use of folic acid tablets with NDC 11534-165?
A: Folic acid tablets are primarily used to prevent and treat folate deficiency, especially in pregnant women to prevent neural tube defects.
Q: Who distributes folic acid tablets with NDC 11534-165?
A: These tablets are distributed by Sunrise Pharmaceutical, Inc.
Q: What is the significance of the NDC number for folic acid tablets?
A: The NDC number (11534-165) is a unique identifier assigned by the FDA, used to track and regulate the drug.
Q: How does competition affect the pricing of folic acid tablets?
A: Competition from multiple generic versions drives prices down, making folic acid tablets more affordable.
Q: What are the key factors influencing price projections for folic acid tablets?
A: Key factors include manufacturing and distribution costs, market competition, and regulatory influences.
Sources
- FDA.report: NDC 11534-165 Oral Tablet FOLIC ACID Drug Codes.
- FDA: National Drug Code Directory.
- FDA: National Drug Code Database Background Information.
- CMS: Drug Name and National Drug Code (NDC) Reference Data Instructions.
