Introduction
The pharmaceutical market is complex and dynamic, with various factors influencing the availability and pricing of drugs. This analysis focuses on the market dynamics and price projections for Amphetamine Mixed Salts Extended-Release Capsules, specifically those with the National Drug Code (NDC) 00115-1487.
Drug Overview
Amphetamine Mixed Salts Extended-Release Capsules, with the NDC 00115-1487, are manufactured by Amneal Pharmaceuticals of New York LLC. These capsules contain a combination of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, and are available in various strengths, including 5 mg, 10 mg, 15 mg, 20 mg, 25 mg, and 30 mg[1][4].
Current Market Status
As of the latest updates, there are significant shortages and supply disruptions affecting these capsules. Several manufacturers, including Amneal, Teva, Lannett, and Rhodes, have reported intermittent back orders and allocations. For instance, Lannett has the 5 mg, 10 mg, 25 mg, and 30 mg capsules on intermittent back order, with the 15 mg capsules expected to be released by mid-December 2024 and the 20 mg capsules on allocation[1].
Reasons for Shortages
The reasons for these shortages vary among manufacturers. Amneal did not provide a specific reason, while Camber and Par have discontinued their production of these capsules. Mallincrodt refuses to provide availability information, and Prasco discontinued their authorized generic version in March 2024[1].
Impact on Pricing
Shortages and supply disruptions can significantly impact drug prices. When demand exceeds supply, prices tend to rise. However, specific price data for NDC 00115-1487 is not readily available in the public domain. Generally, prices for prescription medications can fluctuate based on market conditions, regulatory changes, and competition.
Price Trends in Similar Medications
While direct price data for NDC 00115-1487 is not available, we can look at trends in similar medications. For example, the prices of Adderall 30 mg immediate-release tablets (a different formulation but similar active ingredients) have remained relatively stable over the past year, ranging from $10.27 to $10.30 per unit[5].
Market Projections
Given the current shortages and the anticipated release dates for some strengths, here are some market projections:
- Short-Term: Prices may remain volatile or increase slightly due to the ongoing shortages and back orders. Patients and healthcare providers may need to explore alternative treatments or wait for the anticipated release dates.
- Mid-Term: As supplies become more available, particularly with the expected release of the 15 mg capsules by mid-December 2024, prices are likely to stabilize. However, the impact of discontinued products from other manufacturers could still affect overall market dynamics.
- Long-Term: The life sciences industry is expected to see significant transformation driven by digital advancements and scientific innovations. This could lead to more efficient production and distribution, potentially stabilizing prices and improving availability in the long term[3].
Regulatory and Safety Considerations
The Centers for Disease Control and Prevention (CDC) has issued a health advisory regarding the potential disrupted access to care for patients taking prescription stimulant medications, highlighting possible increased risks for injury and overdose[1].
Competitive Landscape
The competitive landscape in the life sciences industry is highly dynamic. With the patent cliff looming and more than $300 billion in sales at risk through 2030 due to expiring patents, companies are likely to focus on mergers and acquisitions, and the development of new therapeutic solutions[3].
Conclusion
The market for Amphetamine Mixed Salts Extended-Release Capsules (NDC: 00115-1487) is currently characterized by shortages and supply disruptions, which can lead to price volatility. As the industry navigates these challenges, the integration of digital technologies and innovative therapeutic solutions is expected to play a crucial role in stabilizing the market and improving patient outcomes.
Key Takeaways
- Shortages and Supply Disruptions: Ongoing shortages affect various strengths of Amphetamine Mixed Salts Extended-Release Capsules.
- Price Volatility: Prices may increase due to supply-demand imbalances.
- Regulatory Considerations: CDC health advisories highlight potential risks due to disrupted access to care.
- Long-Term Projections: Digital advancements and scientific innovations are expected to improve market stability.
- Competitive Landscape: The industry faces significant changes due to patent expirations and competitive pressures.
FAQs
Q: What are the reasons for the current shortages of Amphetamine Mixed Salts Extended-Release Capsules?
A: The reasons include discontinuation by some manufacturers, intermittent back orders, and refusal to provide availability information by others.
Q: How do shortages affect the pricing of these capsules?
A: Shortages can lead to price increases due to supply-demand imbalances.
Q: Are there any alternative treatments available for patients affected by these shortages?
A: Yes, other manufacturers like Aytu BioPharma offer alternative products such as Adzenys XR oral disintegrating tablets.
Q: What is the expected impact of digital advancements on the pharmaceutical industry?
A: Digital advancements are expected to boost operational efficiencies and drive breakthrough innovations.
Q: How do patent expirations affect the life sciences industry?
A: Patent expirations can lead to significant losses in sales and drive interest in mergers and acquisitions to maintain market positions.
Sources
- ASHP - Drug Shortage Detail: Amphetamine Extended-Release Oral Presentations
- DrugPatentWatch - Latest drug prices and trends for NDC 51672-1387
- Deloitte Insights - 2025 life sciences outlook
- FDA.report - NDC 0115-1487 - Dextroamphetamine Sulfate
- DrugPatentWatch - Drug Price Trends for NDC 57844-0130
