Introduction
Amphetamine mixed salts, commonly known by the brand name Adderall, are widely used to treat Attention Deficit Hyperactivity Disorder (ADHD) and certain cases of narcolepsy. The specific NDC code 72516-016-01 refers to a formulation containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets, manufactured by Oryza Pharmaceuticals Inc.
Current Market Status
As of the latest updates, the market for amphetamine mixed salts is characterized by several key factors:
Supply and Demand
The market is currently experiencing supply chain disruptions. Several manufacturers, including Alvogen, Granules, Mallinckrodt, Rhodes, and Teva, are facing backorders and limited supply issues for various strengths of amphetamine mixed salts immediate-release tablets[3].
- Alvogen: The 5 mg, 20 mg, and 30 mg tablets are on intermittent back order, with supplies being released as they become available.
- Granules: The 7.5 mg and 12.5 mg tablets are on back order, with an estimated release date of January 2025.
- Mallinckrodt: Most strengths are available in limited supply.
- Rhodes: All presentations are on back order with no estimated release date.
- Teva: The 7.5 mg, 10 mg, 12.5 mg, 15 mg, 20 mg, and 30 mg tablets are on intermittent back order.
Price Trends
The pricing for amphetamine mixed salts, specifically the 30 mg immediate-release tablets (though not the exact NDC 72516-016-01), has been relatively stable over recent months. For example, the price per unit for the 30 mg Adderall tablets (NDC 57844-0130-01) has fluctuated slightly but remains around $10.27 per unit[2].
Price Projections
Given the current supply chain issues and the stable pricing trend, here are some projections:
Short-Term Projections
- Supply Constraints: The ongoing backorders and limited supply from various manufacturers are likely to continue affecting the market. This could lead to temporary price increases due to demand outpacing supply.
- Price Stability: Despite supply issues, the prices are expected to remain relatively stable in the short term, as manufacturers continue to release supplies as they become available.
Long-Term Projections
- Market Stabilization: As supply chains normalize and manufacturers resolve their backorder issues, prices are expected to stabilize and potentially decrease slightly due to increased competition and availability.
- Regulatory Impact: Any changes in regulatory policies or health advisories, such as those issued by the CDC regarding potential disrupted access to prescription stimulants, could influence market dynamics and pricing[3].
Safety and Regulatory Considerations
The use of amphetamine mixed salts is associated with several safety concerns, including a high potential for abuse and misuse, which can lead to substance use disorders and addiction. The CDC has issued health advisories regarding the potential risks associated with disrupted access to these medications[3].
Pharmacokinetics and Clinical Use
The formulation of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate tablets contains d-amphetamine and l-amphetamine salts in a 3:1 ratio. The pharmacokinetics show peak plasma concentrations approximately 3 hours post-dose, with dose-proportional pharmacokinetics observed between 10 mg and 30 mg doses[1].
Key Takeaways
- Supply Chain Issues: Ongoing backorders and limited supply from multiple manufacturers.
- Price Stability: Prices are expected to remain relatively stable despite supply constraints.
- Regulatory Considerations: Safety concerns and regulatory advisories can impact market dynamics.
- Pharmacokinetics: Dose-proportional pharmacokinetics with peak plasma concentrations approximately 3 hours post-dose.
FAQs
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What is the current supply status of amphetamine mixed salts (NDC: 72516-016-01)?
- The current supply is affected by backorders and limited availability from various manufacturers.
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How have prices for amphetamine mixed salts been trending?
- Prices have been relatively stable, with minor fluctuations around $10.27 per unit for the 30 mg tablets.
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What are the potential long-term price projections for amphetamine mixed salts?
- Prices are expected to stabilize and potentially decrease as supply chains normalize.
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What safety concerns are associated with amphetamine mixed salts?
- High potential for abuse and misuse, leading to substance use disorders and addiction, as well as peripheral vasculopathy including Raynaud’s phenomenon.
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How do regulatory advisories impact the market for amphetamine mixed salts?
- Regulatory advisories, such as those from the CDC, can influence market dynamics and highlight potential risks associated with disrupted access to these medications.
Sources
- DailyMed: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet[1].
- DrugPatentWatch: Drug Price Trends for NDC 57844-0130[2].
- ASHP: Amphetamine Mixed Salts, Immediate-Release Tablets[3].
