Market Analysis and Price Projections for the Drug NDC: 66993-0021
Introduction to National Drug Codes (NDCs)
The National Drug Code (NDC) is a unique, three-segment number assigned by the FDA to identify drug products. For the NDC 66993-0021, which corresponds to Levalbuterol Hydrochloride manufactured by Prasco Laboratories, understanding the NDC system is crucial for market analysis and price projections[2][5].
Understanding the NDC 66993-0021
- Labeler Code: The first segment, 66993, identifies Prasco Laboratories as the labeler.
- Product Code: The second segment identifies the specific strength, dosage form, and formulation of Levalbuterol Hydrochloride.
- Package Code: The third segment specifies the package size and type[5].
Market Analysis
Current Market Trends
The US pharmaceutical market, particularly the segment for respiratory drugs like Levalbuterol Hydrochloride, is influenced by several factors:
- Generic Market Competition: The presence of generic versions of Levalbuterol Hydrochloride can lead to competitive pricing. Generic drugs often experience annual price erosion due to market competition and regulatory pressures[4].
- Regulatory Changes: Updates to regulatory policies, such as changes in the Medicaid Drug Rebate Program or new FDA guidelines, can impact pricing and market dynamics[2].
- Technological Advancements: The adoption of AI and other technological advancements can reduce development and manufacturing costs, potentially leading to lower prices[3].
Market Size and Growth Projections
The US pharmaceutical market is projected to grow significantly, with the overall market expected to reach $1.28 trillion by 2030, growing at a CAGR of 5.36% from 2022 to 2030. This growth is driven by factors such as rising pharmaceutical production capacity, greater approvals of generic drugs, and escalating R&D investments[2].
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 Unit Rebate Amount (URA) from the Average Manufacturer Price (AMP) for the smallest unit of measure. This calculation is crucial for determining the ceiling price for covered outpatient drugs[2].
Example Calculation
If we consider the following hypothetical values for Levalbuterol Hydrochloride (NDC 66993-0021):
- AMP: $50 per unit
- URA: $10 per unit
- Package Size: 10 units
- Case Pack Size: 5 packages
The 340B ceiling price would be calculated as:
[ \text{340B Ceiling Price} = (50 - 10) \times 10 \times 5 = \$2000 ]
This provides a baseline for the ceiling price, but actual market prices can vary based on market demand, competition, and regulatory changes[2].
Price Projections
Historical Pricing Data
Reviewing historical pricing data for Levalbuterol Hydrochloride can provide insights into price trends and potential future adjustments. Given the competitive nature of the generic drug market, prices are expected to erode annually by mid-single-digit percentages[4].
Future Pricing Trends
- Annual Price Erosion: Expect prices to decrease by around 3-5% annually due to market competition and regulatory pressures.
- Revenue Growth: Despite price erosion, the overall revenue for generic drugs may still grow modestly due to increased volume and market penetration.
- Cost Recovery: Companies will need to balance their pricing to cover costs, including distribution, marketing (if applicable), and earning a reasonable return on investment[4].
Example Scenario
If the current price of Levalbuterol Hydrochloride (NDC 66993-0021) is $50 per unit, here is a possible price projection over the next few years:
| Year |
Price per Unit |
| 2024 |
$50 |
| 2025 |
$47.50 |
| 2026 |
$45.13 |
| 2027 |
$42.87 |
| 2028 |
$40.71 |
This scenario assumes an annual price erosion of about 5%, which is within the expected range for generic drugs[4].
Distribution and Marketing
The distribution and marketing strategies for Levalbuterol Hydrochloride can also influence its pricing. For instance, if Prasco Laboratories does not engage in direct-to-consumer marketing or paid advertising, costs can be kept lower, allowing for more competitive pricing[4].
Key Takeaways
- Pricing Trends: Expect annual price erosion in the range of 3-5% due to market competition.
- Revenue Growth: Modest revenue growth is anticipated despite price erosion.
- Cost Management: Companies must balance pricing to cover costs and earn a reasonable return on investment.
- Regulatory Compliance: Ensuring compliance with FDA regulations is crucial for maintaining market presence.
- Market Demand: Increasing demand for respiratory drugs can support higher sales volumes.
FAQs
Q: What is the significance of the NDC in the pharmaceutical market?
A: The NDC is a unique identifier assigned by the FDA to track, price, and ensure regulatory compliance of drug products in the U.S. market[5].
Q: How is the 340B ceiling price calculated for covered outpatient drugs?
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 adjusted by package size and case pack size[2].
Q: What factors influence price projections for pharmaceuticals?
A: Historical pricing data, regulatory changes, market demand, competition, and technological advancements are key factors that influence price projections[2].
Q: How does market competition affect the pricing of generic drugs?
A: Market competition typically leads to annual price erosion of 3-5% for generic drugs due to the presence of multiple manufacturers and the need to remain competitive[4].
Q: What role do technological advancements play in drug pricing?
A: Technological advancements, such as AI and other innovations, can reduce development and manufacturing costs, potentially leading to lower prices for pharmaceutical products[3].
Sources
- FindACode: Prasco Laboratories - List of Drugs - NDC Labeler/Manufacturer[1].
- DrugPatentWatch: Market Analysis and Financial Projection Experimental[2].
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025[3].
- DrugPatentWatch: Latest drug prices and trends for NDC 00093-7664[4].
- FDA: National Drug Code Database Background Information[5].
