Overview of Modafinil
Modafinil, with the NDC code 72578-006, is a prescription drug categorized under the central nervous system stimulants. It is distributed by Viona Pharmaceuticals Inc. and is used primarily to treat conditions such as narcolepsy, shift work sleep disorder, and obstructive sleep apnea[1].
Market Context
The pharmaceutical market, particularly for prescription drugs like Modafinil, is influenced by several factors including regulatory changes, technological advancements, and market demand.
Biopharma and Biotech Industry Trends
The biopharma and biotech industries are experiencing rapid growth, driven by advancements in technological capabilities and evolving regulatory frameworks. The biopharma market size was estimated to be over $400 billion in 2024, with a projected compound annual growth rate (CAGR) of 7.56% between 2024 and 2029[3].
Pricing and Cost Analysis
Current Pricing
As of the latest available data, the pricing for Modafinil (NDC 72578-006) is not explicitly provided in the sources. However, it is common for generic drugs like Modafinil to have competitive pricing due to the presence of multiple manufacturers.
Price Trends in Pharmaceutical Market
In general, pharmaceutical prices can fluctuate based on various factors such as production costs, market demand, and regulatory changes. For example, specialty pharmaceuticals have seen a trend of price increases, with an overall trend of a 3.8% increase[4].
Regulatory Environment
DEA Schedule and Marketing Category
Modafinil is classified as a Schedule IV controlled substance by the DEA, indicating it has a lower potential for abuse compared to Schedule III substances but can still lead to physical or psychological dependence. It is marketed under the ANDA (Abbreviated New Drug Application) category, which allows for the approval of generic drugs that are bioequivalent to the brand-name drug[1].
Market Projections
Clinical Trial Innovations
The shift towards more innovative clinical trial designs, such as adaptive trials and basket trials, is expected to impact the development and approval process of drugs like Modafinil. These designs can lead to faster approval times and more efficient use of resources, potentially influencing the pricing and availability of the drug[3].
Precision Medicine and AI/ML
The increasing focus on precision medicine and the use of AI and machine learning (AI/ML) technologies in drug development are likely to enhance the efficacy and safety of treatments. While these advancements may not directly impact the pricing of existing drugs like Modafinil, they could influence the overall market dynamics and competition[3].
Price Projections
Given the lack of specific pricing data for NDC 72578-006, we can infer potential price trends from broader market observations:
- Generic Drug Pricing: Generic drugs tend to have stable or slightly decreasing prices over time due to competition among manufacturers.
- Market Demand: If demand for Modafinil remains consistent or increases, prices might stabilize or see a slight increase.
- Regulatory Changes: Any significant changes in regulatory frameworks could impact production costs and subsequently the pricing of the drug.
Key Takeaways
- Market Growth: The biopharma and biotech industries are growing rapidly, driven by technological and regulatory advancements.
- Regulatory Environment: Modafinil is a Schedule IV controlled substance and is marketed under the ANDA category.
- Pricing Trends: Generic drugs like Modafinil typically experience stable or slightly decreasing prices due to market competition.
- Innovative Clinical Trials: New clinical trial designs and the use of AI/ML technologies may influence the development and approval of drugs, potentially affecting market dynamics.
FAQs
1. What is the primary use of Modafinil?
Modafinil is primarily used to treat conditions such as narcolepsy, shift work sleep disorder, and obstructive sleep apnea.
2. Who distributes Modafinil with the NDC code 72578-006?
Modafinil with the NDC code 72578-006 is distributed by Viona Pharmaceuticals Inc.
3. What is the DEA classification of Modafinil?
Modafinil is classified as a Schedule IV controlled substance by the DEA.
4. How are prices for generic drugs like Modafinil typically influenced?
Prices for generic drugs like Modafinil are typically influenced by market competition, production costs, and regulatory changes.
5. What are the expected trends in the biopharma and biotech industries in 2025?
The biopharma and biotech industries are expected to see accelerated clinical trial designs, evolving regulatory frameworks, a rise in precision medicine, and increased use of AI/ML technologies.
Sources
- FDA.report: NDC 72578-006 Oral Tablet Modafinil Drug Codes.
- DrugPatentWatch: Latest pharmaceutical drug prices and trends.
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025.
- DrugPatentWatch: Latest drug prices and trends for NDC 72819-0160.
- FDA.report: NDC 72578-036 - Metformin Hydrochloride.
