Overview of Dextroamphetamine Sulfate
Dextroamphetamine sulfate, with the NDC code 0555-0953, is a central nervous system stimulant marketed by Teva Pharmaceuticals USA, Inc. It is used to treat conditions such as attention deficit hyperactivity disorder (ADHD) and narcolepsy. The drug is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse[1][5].
Current Market Context
Generic Drug Market Trends
The generic drug market, where dextroamphetamine sulfate is categorized, is experiencing several key trends. There is an expectation of mid-single-digit percent annual price erosion, which is a common phenomenon in the commodity-like generic drug industry. However, this erosion is anticipated to be offset by modest revenue growth, marking an improvement from recent years[3].
Price Transparency and Regulatory Environment
Price transparency remains a significant issue in the pharmaceutical industry. Reports have highlighted variable quality in the information submitted by manufacturers, which complicates the understanding of price increases. For instance, the median price increase for generic drugs was 19.9% in 2022, with some generic drugs experiencing dramatic price hikes, such as a 2,527% increase for a generic naproxen[2].
Price Projections
Overall Pharmaceutical Market
For 2024, the overall pharmaceutical market is projected to see a 3.8% increase in drug prices, driven largely by specialty pharmaceuticals. While this projection is more relevant to specialty drugs, it sets a broader context for the pharmaceutical market's pricing trends[4].
Generic Drugs
Specific to generic drugs, the expectation is for a mid-single-digit percent annual price erosion. This means that the price of dextroamphetamine sulfate could potentially decrease, albeit modestly, over the coming year. However, this decrease might be mitigated by overall market conditions and the specific dynamics of the drug's supply chain[3].
Factors Influencing Price
Supply Chain and Manufacturing
The supply chain for generic drugs, including dextroamphetamine sulfate, can be influenced by various factors such as FDA inspections of foreign manufacturing facilities and potential price-fixing litigation. These factors could impact the stability and cost of the drug supply, thereby affecting its market price[3].
Regulatory Oversight
Regulatory oversight and transparency measures are increasingly important. Recommendations for greater transparency across the pharmaceutical supply chain, including aspects like coupons, discounts, fees, and rebates, could influence how drug prices are set and reported. This increased transparency might lead to more stable and predictable pricing for generic drugs like dextroamphetamine sulfate[2].
Market Share and Competition
Biosimilars and Generic Competition
While dextroamphetamine sulfate is a generic drug, the broader market is seeing an increase in biosimilars, which could indirectly affect the pricing and market share of generic drugs. Biosimilars are expected to grow in market share, particularly for drugs like adalimumab, but this trend is more relevant to biologic drugs rather than traditional generics like dextroamphetamine sulfate[4].
Conclusion
The market analysis for dextroamphetamine sulfate (NDC: 0555-0953) suggests that while the generic drug market is expected to experience price erosion, the overall pharmaceutical market trends and regulatory environment will play significant roles in determining the drug's price. Here are some key takeaways:
- Price Erosion: Mid-single-digit percent annual price erosion is expected for generic drugs.
- Regulatory Environment: Increased transparency and regulatory oversight could stabilize prices.
- Supply Chain: FDA inspections and potential litigation could impact supply chain stability.
- Market Trends: Specialty pharmaceuticals are driving the overall increase in drug prices, but this has a limited direct impact on generic drugs like dextroamphetamine sulfate.
Key Takeaways
- Generic Drug Price Trends: Expect modest price decreases due to market erosion.
- Regulatory Impact: Transparency and oversight can stabilize prices.
- Supply Chain Risks: FDA inspections and litigation can affect supply chain stability.
- Market Competition: Biosimilars are growing in market share but are less relevant to traditional generics.
FAQs
Q: What is the current DEA classification for dextroamphetamine sulfate?
A: Dextroamphetamine sulfate is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse[1][5].
Q: What are the projected price trends for generic drugs in 2024?
A: Generic drugs are expected to experience mid-single-digit percent annual price erosion, with modest revenue growth[3].
Q: How does the regulatory environment impact drug pricing?
A: Increased transparency and regulatory oversight can help stabilize prices and provide better understanding of price increases[2].
Q: What role do biosimilars play in the pharmaceutical market?
A: Biosimilars are expected to grow in market share, particularly for biologic drugs, but have limited direct impact on traditional generics like dextroamphetamine sulfate[4].
Q: What factors could influence the supply chain stability of generic drugs?
A: FDA inspections of foreign manufacturing facilities and potential price-fixing litigation are significant factors that could impact supply chain stability[3].
Sources
- FDA Report: NDC 0555-0953 Oral Tablet Dextroamphetamine Sulfate Drug.
- Oregon Prescription Drug Price Transparency Report: Prescription Drug Price Transparency Results and Recommendations.
- S&P Global Ratings: Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures.
- Vizient Inc.: Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals.
- DailyMed: Label: DEXTROAMPHETAMINE SULFATE tablet.
