Introduction
The pharmaceutical market is a complex and dynamic environment, influenced by various factors including regulatory changes, competition from generics and biosimilars, and advancements in technology. This article focuses on the market analysis and price projections for the drug identified by the NDC code 64850-504, which is a combination of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.
Drug Overview
Proprietary and Generic Names
The proprietary name of this drug is a combination of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. It is available in a generic form under the same active ingredient names[1].
Dosage Form and Route of Administration
This medication is administered orally in the form of tablets. Each tablet contains a specific strength of the active ingredients, which are crucial for managing conditions such as Attention Deficit Hyperactivity Disorder (ADHD) and certain cases of narcolepsy[1].
Marketing and Regulatory Status
The drug was approved under an Abbreviated New Drug Application (ANDA) and is marketed by Elite Laboratories, Inc. The marketing start date was December 11, 2018[1].
Market Trends and Competition
Generic and Biosimilar Competition
The pharmaceutical industry is facing significant competition from generic drugs and biosimilars. For drugs like the one identified by NDC 64850-504, the presence of generic alternatives can impact pricing and market share. According to Deloitte's life sciences outlook, 37% of respondents view competition from generic drugs and biosimilars as a top trend affecting their strategies[3].
Patent Expiration and Market Impact
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 trend could lead to increased competition and potentially lower prices for drugs that lose patent protection[3].
Pricing and Access
Current Pricing
As of the latest data, specific pricing details for NDC 64850-504 are not readily available. However, the pricing of similar medications can provide some insight. Generally, the prices of generic medications tend to be lower than their brand-name counterparts.
Price Projections
Given the competitive landscape and the impact of generic competition, it is likely that the prices of drugs like NDC 64850-504 will remain stable or decrease slightly over the next few years. The overall pharmaceutical market is expected to grow, but the generic segment may see continued price pressure due to increased competition[4].
Regulatory and Reimbursement Environment
DEA Schedule and Abuse Potential
This medication is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse. This classification can affect pricing and access, as stricter regulations may limit prescribing and dispensing practices[5].
Reimbursement and Access
Pricing and access to drugs are significant concerns in the life sciences industry. Nearly half of the C-suite executives surveyed by Deloitte expect pricing and access issues to significantly affect their strategies in 2025. This trend highlights the need for pharmaceutical companies to navigate complex reimbursement processes and regulatory environments[3].
Technological and Innovative Trends
Digital Transformation and R&D
The life sciences industry is undergoing significant transformation driven by digital advancements and scientific innovations. The integration of technologies like genomics, biomarkers, and AI is expected to boost operational efficiencies and drive breakthrough innovations. These advancements could lead to more personalized and effective treatments, potentially impacting the market for existing medications[3].
Market Expansion and Mergers & Acquisitions
Strategic Initiatives
Companies in the life sciences industry are exploring various initiatives to enhance their market positions. With the looming patent cliff and increased competition, there is a growing expectation that mergers and acquisitions will increase in 2025. This trend could lead to consolidation in the market and potentially impact the pricing and availability of drugs like NDC 64850-504[3].
Patient Outcomes and Therapeutic Solutions
Personalized Medicine
Advances in genomics and biomarkers are enabling more precise treatment options, which can improve efficacy and reduce side effects. This shift towards personalized medicine could influence the demand for certain medications and impact market dynamics[3].
Key Takeaways
- Competition from Generics: The presence of generic alternatives is a significant factor in the pricing and market share of drugs like NDC 64850-504.
- Regulatory Environment: The DEA Schedule CII classification and reimbursement processes can affect pricing and access.
- Technological Advancements: Digital transformation and scientific innovations are driving changes in the life sciences industry.
- Market Trends: The industry is poised for significant transformation, with a focus on R&D and personalized medicine.
- Price Projections: Prices are likely to remain stable or decrease slightly due to competition and regulatory pressures.
FAQs
What is the proprietary name of the drug identified by NDC 64850-504?
The proprietary name of the drug is a combination of dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.
What is the dosage form and route of administration for this drug?
The drug is administered orally in the form of tablets.
Why is the drug classified as a Schedule CII controlled substance?
The drug is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse.
How does the presence of generic alternatives affect the pricing of this drug?
The presence of generic alternatives can lead to lower prices and increased competition, potentially impacting the market share of the drug.
What are the key trends affecting the life sciences industry in 2025?
Key trends include pricing and access issues, competition from generics and biosimilars, the patent cliff, and the impact of digital transformation and scientific innovations.
Sources
- FDA Report: NDC 64850-504 Oral Tablet Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate.
- DrugPatentWatch: Latest drug prices and trends for NDC 50419-0459.
- Deloitte Insights: 2025 life sciences outlook.
- DrugPatentWatch: Latest pharmaceutical drug prices and trends for NDC 42806-0006.
- DailyMed: Label: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet.
