Market Analysis and Price Projections for the Drug NDC: 42806-343-01
Introduction to NDC Codes and Drug Identification
The National Drug Code (NDC) is a unique identifier assigned to each drug product by the FDA, helping in the tracking and regulation of pharmaceuticals. The NDC code 42806-343-01 corresponds to a specific formulation of amphetamine, a prescription drug marketed by Epic Pharma, LLC[1].
Market Context: Pharmaceutical Industry Outlook
The pharmaceutical industry is poised for significant growth and changes in the coming years. According to Evaluate's 2024 World Preview Report, global prescription drug sales are projected to reach $1.7 trillion by 2030, driven by a shift towards treating major diseases such as obesity[4].
Generic Drug Market Dynamics
In the generic drug sector, where amphetamine falls, mid-single-digit percent annual price erosion is expected. However, this erosion is anticipated to be balanced by modest revenue growth, marking an improvement from recent trends. The generic drug industry faces challenges such as price-fixing litigation and increased FDA inspections of foreign manufacturing facilities[3].
Pricing Trends and Negotiations
High prescription drug prices continue to be a significant issue in the U.S., affecting patients, healthcare payers, and taxpayers. Recent data from the Medicare Drug Price Negotiation Program highlights substantial price increases for many drugs between 2018 and 2023, with some drugs experiencing increases of 20 to 55 percent. However, negotiated prices under Medicare Part D are expected to result in discounts ranging from 38 to 79 percent starting in January 2026[2].
Specific Drug Pricing: Amphetamine
Amphetamine, under the NDC code 42806-343-01, is classified as a DEA Schedule CII drug, indicating its potential for abuse and dependence. Given its classification and the ongoing trends in the pharmaceutical market:
Price Erosion
As a generic drug, amphetamine is likely to experience mid-single-digit percent annual price erosion. This is consistent with the broader trends in the generic drug industry[3].
Market Demand
The demand for amphetamine, particularly for conditions like ADHD and narcolepsy, remains steady. However, the market is highly competitive, and pricing is influenced by regulatory and market forces.
Regulatory Impact
The FDA's oversight and any changes in regulatory requirements can impact the pricing and availability of amphetamine. For instance, increased inspections of foreign manufacturing facilities could lead to temporary shortages or price fluctuations[5].
Medicare Negotiations and Impact on Pricing
The Medicare Drug Price Negotiation Program, set to begin in January 2026, will significantly impact the pricing of drugs, including potentially those in the generic sector. While amphetamine is not specifically listed among the first 10 drugs selected for negotiation, the broader impact of these negotiations on the pharmaceutical market could influence pricing strategies across the board[2].
Forecasting Price Projections
Given the current market dynamics:
- Short-Term Projections: In the immediate future, prices for amphetamine are likely to remain stable or experience slight decreases due to the anticipated mid-single-digit percent annual price erosion in the generic drug sector.
- Long-Term Projections: By 2030, the overall pharmaceutical market is expected to grow significantly, but the generic segment may see continued price pressure. However, the demand for essential medications like amphetamine is likely to sustain, albeit with potentially lower profit margins due to increased competition and regulatory pressures.
Key Takeaways
- Market Growth: The global pharmaceutical market is projected to grow significantly by 2030.
- Price Erosion: Generic drugs, including amphetamine, are expected to experience mid-single-digit percent annual price erosion.
- Regulatory Impact: FDA regulations and Medicare negotiations can significantly influence drug pricing.
- Demand Stability: The demand for amphetamine is likely to remain steady due to its use in treating chronic conditions.
FAQs
Q: What is the NDC code 42806-343-01 associated with?
A: The NDC code 42806-343-01 is associated with a specific formulation of amphetamine, a prescription drug marketed by Epic Pharma, LLC.
Q: How is the generic drug market expected to perform in 2024?
A: The generic drug market is expected to experience mid-single-digit percent annual price erosion but with a return to modest revenue growth.
Q: What impact will Medicare drug price negotiations have on the pharmaceutical market?
A: Medicare drug price negotiations are expected to result in significant discounts, ranging from 38 to 79 percent, starting in January 2026.
Q: How does the FDA regulate drugs using NDC codes?
A: The FDA uses NDC codes to track and regulate drug products, requiring drug establishments to provide a current list of all drugs manufactured or processed for sale in the U.S.[5].
Q: What are the projected global prescription drug sales by 2030?
A: Global prescription drug sales are projected to reach $1.7 trillion by 2030, driven by a shift towards treating major diseases like obesity[4].
Sources
- PharmaCompass.com - NDC Code 42806-343-01 - Amphetamine
- ASPE.HHS.gov - Medicare Drug Price Negotiation Program
- SPGlobal.com - Pharmaceutical Industry 2024 Credit Outlook
- Evaluate.com - Evaluate Releases 2030 Forecasts for Global Pharmaceutical Market
- FDA.gov - National Drug Code Directory
