Market Analysis and Price Projections for NDC 64980-104: Dibasic Sodium Phosphate, Monobasic Potassium Phosphate, and Monobasic Sodium Phosphate
Introduction
The drug identified by the NDC code 64980-104 is a combination of dibasic sodium phosphate, monobasic potassium phosphate, and monobasic sodium phosphate, marketed as an oral tablet. This analysis will delve into the market dynamics, pricing strategies, and future projections for this pharmaceutical product.
Market Overview
Product Description
This drug is a phosphorus supplement, each tablet providing a specific amount of dibasic sodium phosphate, monobasic potassium phosphate, and monobasic sodium phosphate. It is used to increase urinary phosphate and pyrophosphate levels and is particularly beneficial in conditions such as idiopathic hypercalciuria[3].
Label and Distribution
The product is labeled and distributed by Rising Pharmaceuticals, Inc., and falls under the category of human prescription drugs. It is classified as an unapproved drug other than an approved drug, meaning it has not been found by the FDA to be safe and effective, and its labeling has not been approved by the FDA[1][3].
Pricing and Cost Structure
Current Pricing
The pricing of this drug is not explicitly stated in the available sources, but it can be inferred that the cost is influenced by several factors including manufacturing, marketing, and distribution costs. For similar pharmaceutical products, the Wholesale Acquisition Cost (WAC) is a key metric. However, for this specific NDC, detailed WAC information is not provided[2].
Cost Components
The overall cost of the drug includes:
- Manufacturing Costs: This involves the cost of raw materials, labor, and overheads associated with producing the tablets.
- Marketing Costs: Although the drug does not have direct-to-consumer marketing or paid advertising, there are still costs associated with promoting the product to healthcare professionals and distributing product information materials[2].
- Distribution Costs: These costs include the expenses related to getting the product from the manufacturer to the end consumer, such as logistics and storage.
Market Dynamics
Demand and Supply
The demand for this drug is likely driven by the need for phosphorus supplements in specific medical conditions. The supply is managed by Rising Pharmaceuticals, Inc., and other potential generic manufacturers. The market dynamics can be influenced by regulatory changes, competition from other phosphorus supplements, and the overall healthcare landscape.
Competitive Landscape
The competitive landscape for phosphorus supplements is relatively niche but can be competitive. Other manufacturers may offer similar products, and the pricing strategy will need to consider these competitors. For instance, generic versions of similar drugs can significantly impact pricing due to their lower costs and wider availability[2].
Price Projections
Short-Term Projections
In the short term, the price of the drug is likely to remain stable unless there are significant changes in the cost structure or market dynamics. Given that the drug is an unapproved drug other than an approved drug, any changes in FDA regulations or approval status could impact pricing.
Long-Term Projections
Long-term price projections are more speculative but can be influenced by several factors:
- Generic Competition: If generic versions of this drug become more prevalent, it could lead to a reduction in prices due to increased competition.
- Regulatory Changes: Approval or changes in the regulatory status of the drug could impact pricing. For example, if the drug were to be approved by the FDA, it might gain more market credibility and potentially higher pricing.
- Market Demand: Changes in the prevalence of conditions requiring phosphorus supplements could influence demand and subsequently prices.
Example of Price Reductions in Similar Markets
For instance, Dr. Reddy’s introduction of Lenalidomide, a generic version of Revlimid, resulted in a 14% reduction in the WAC pricing compared to the branded version. This illustrates how generic competition can drive down prices in the pharmaceutical market[2].
Key Considerations for Pricing Strategy
Regulatory Compliance
The drug's status as an unapproved drug other than an approved drug means that any pricing strategy must be cautious and compliant with FDA guidelines.
Market Feedback
Continuous monitoring of market feedback from healthcare professionals and patients is crucial. This can help in adjusting the pricing strategy to better align with market needs and expectations.
Cost Management
Effective management of manufacturing, marketing, and distribution costs is essential to maintain profitability while keeping prices competitive.
Key Takeaways
- Market Stability: The current market for NDC 64980-104 is relatively stable, with prices likely to remain consistent in the short term.
- Generic Competition: The potential for generic competition could lead to price reductions in the long term.
- Regulatory Impact: Changes in regulatory status or approval could significantly impact pricing and market dynamics.
- Cost Management: Efficient cost management is crucial for maintaining profitability and competitive pricing.
FAQs
What is the primary use of the drug NDC 64980-104?
The primary use of the drug NDC 64980-104 is as a phosphorus supplement to increase urinary phosphate and pyrophosphate levels, particularly beneficial in conditions such as idiopathic hypercalciuria.
Who is the distributor of this drug?
The drug is distributed by Rising Pharmaceuticals, Inc.
What is the regulatory status of this drug?
This drug is classified as an unapproved drug other than an approved drug, meaning it has not been found by the FDA to be safe and effective, and its labeling has not been approved by the FDA.
How might generic competition affect the price of this drug?
Generic competition could lead to a reduction in prices due to increased competition and lower costs associated with generic versions.
What factors influence the pricing of this drug?
The pricing is influenced by manufacturing costs, marketing costs, distribution costs, regulatory changes, and market demand.
Can changes in FDA regulations impact the price of this drug?
Yes, changes in FDA regulations or approval status could significantly impact the pricing and market dynamics of this drug.
How does the cost structure of this drug compare to other pharmaceuticals?
The cost structure includes manufacturing, marketing, and distribution costs, similar to other pharmaceuticals. However, the specific costs and their impact on pricing can vary based on the drug's unique market position and regulatory status.
