Introduction
Adzenys ER, with the NDC code 70165-003, is an extended-release oral suspension of amphetamine, marketed by Neos Therapeutics, LP. This medication is classified as a Central Nervous System Stimulant and is used primarily for the treatment of Attention Deficit Hyperactivity Disorder (ADHD)[1].
Current Market Position
Adzenys ER was introduced to the market in 2017, and since then, it has been a part of the growing market for ADHD treatments. The drug is available in various strengths, including an orally disintegrating tablet form known as Adzenys XR-ODT[5].
Pricing and Cost Considerations
The pricing of Adzenys ER is influenced by several factors, including its DEA Schedule II classification, which indicates a high potential for abuse and dependence. Here are some key points to consider:
- Current Pricing: The exact current pricing of Adzenys ER can vary based on factors such as insurance coverage, pharmacy, and location. However, it is generally priced in line with other extended-release amphetamine products.
- Comparison with International Markets: The U.S. market tends to have significantly higher drug prices compared to other OECD countries and the rest of the world. For example, the average price per unit in the U.S. is 5.5 times higher than in the OECD (excluding the U.S.) and 7.7 times higher than in the rest of the world[4].
Market Trends and Projections
Several trends and projections are relevant to the pricing and market position of Adzenys ER:
Generic and Biosimilar Competition
The life sciences industry is facing increased competition from generic drugs and biosimilars. This trend is expected to continue, with 37% of C-suite executives viewing competition from generics and biosimilars as a top trend in 2025[3].
Patent Cliff and Exclusivity
The biopharma industry is facing a substantial loss of exclusivity due to expiring patents, with over $300 billion in sales at risk through 2030. This could lead to increased interest in mergers and acquisitions, which might impact the pricing strategies of companies like Neos Therapeutics[3].
Regulatory and Pricing Pressures
The Biden-Harris Administration's initiatives to negotiate lower prices for certain drugs under Medicare could set a precedent for broader price reductions in the U.S. market. While Adzenys ER is not currently listed among the drugs selected for Medicare price negotiation, such policies could influence the overall pricing environment[2].
Digital Transformation and Innovation
The life sciences industry is undergoing significant transformation driven by digital advancements and scientific innovations. The integration of technologies like gen AI and increased use of data are expected to boost operational efficiencies and drive breakthrough innovations. This could lead to more personalized and effective treatments, potentially altering market dynamics and pricing strategies[3].
Patient Access and Affordability
Pricing and access to drugs remain significant issues for the life sciences industry. Nearly half of the C-suite executives surveyed expect pricing and access to significantly affect their strategies in 2025. Ensuring patient access and affordability will be crucial for the long-term success of Adzenys ER[3].
Price Projections
Given the current trends and factors influencing the pharmaceutical market:
- Short-Term Projections: In the short term, prices for Adzenys ER are likely to remain stable or see moderate increases, aligned with overall market trends and inflation.
- Long-Term Projections: In the long term, the impact of generic competition, patent expirations, and regulatory pressures could lead to price reductions. Additionally, the increasing focus on patient access and affordability might drive more competitive pricing strategies.
Key Takeaways
- Adzenys ER is part of a competitive ADHD treatment market with high potential for generic and biosimilar competition.
- The U.S. market has significantly higher drug prices compared to international markets.
- Regulatory and pricing pressures, including Medicare price negotiations, could influence the pricing environment.
- Digital transformation and innovation are expected to drive operational efficiencies and breakthrough innovations.
- Ensuring patient access and affordability will be crucial for the long-term success of Adzenys ER.
FAQs
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What is Adzenys ER used for?
Adzenys ER is used for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).
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Who markets Adzenys ER?
Adzenys ER is marketed by Neos Therapeutics, LP.
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What is the DEA classification of Adzenys ER?
Adzenys ER is classified as a DEA Schedule II drug, indicating a high potential for abuse and dependence.
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How does the pricing of Adzenys ER compare to international markets?
The pricing of Adzenys ER in the U.S. is significantly higher compared to other OECD countries and the rest of the world.
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What are the potential long-term price projections for Adzenys ER?
Long-term price projections suggest potential price reductions due to generic competition, patent expirations, and regulatory pressures.
Cited Sources:
- FDA Report: NDC 70165-003 Oral Suspension, Extended Release Adzenys ER.
- White House Fact Sheet: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation.
- Deloitte Insights: 2025 life sciences outlook.
- ASPE Issue Brief: International Market Size and Prices.
- PharmaCompass: NDC Code 70165-030-30 - Amphetamine.
