Drug Overview
The drug with the NDC code 0781-2329 is a formulation of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate, marketed as MAS-ER Capsules. These capsules are indicated for the treatment of attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older[1].
Market Context
The pharmaceutical market, particularly for ADHD medications, is subject to various factors that influence pricing and market dynamics.
Generic Drug Market
The generic drug industry, which includes medications like the one with NDC 0781-2329, is characterized by mid-single-digit percent annual price erosion. However, there is an expectation of modest revenue growth in the coming years, marking an improvement from recent trends[3].
Price Volatility
Generic drugs have seen significant price fluctuations. For instance, the median price increase for generic drugs in 2022 was 19.9%, with some drugs experiencing drastic increases, such as a 2,527% increase for a generic naproxen manufactured by Hikma Pharmaceuticals[2].
Pricing Trends
Given the generic nature of the drug, here are some key pricing trends to consider:
Current Pricing
As of the latest data, the pricing for MAS-ER Capsules would be influenced by the broader generic drug market. However, specific current prices are not provided in the available sources.
Future Projections
- Price Erosion: Expect mid-single-digit percent annual price erosion, which is typical for the generic drug industry. This means that the price of MAS-ER Capsules is likely to decrease over time due to market competition and regulatory pressures[3].
- Revenue Growth: Despite price erosion, the generic drug industry is expected to see modest revenue growth. This growth could be driven by increased demand for ADHD treatments and the expanding patient population[3].
Regulatory and Legal Factors
Several regulatory and legal factors can impact the pricing and market dynamics of MAS-ER Capsules:
DEA Schedule
The drug is classified as a Schedule CII controlled substance, which can affect its distribution and pricing due to stricter regulatory controls[1].
FDA Oversight
The FDA's oversight, including inspections of manufacturing facilities, can influence the supply chain and pricing. Potential increases in FDA inspections of foreign manufacturing facilities could pose risks to the generic drug industry, including price instability[3].
Price-Fixing Litigation
Litigation related to price-fixing can also impact the pricing of generic drugs. Any involvement in such litigation could lead to significant price adjustments and market volatility[3].
Market Competition
The ADHD treatment market is competitive, with several other medications available. The pricing of MAS-ER Capsules will be influenced by competition from other generic and brand-name ADHD medications.
Patient Demand and Market Size
The demand for ADHD treatments is increasing, driven by growing awareness and diagnosis rates. This increased demand can support revenue growth despite price erosion.
Manufacturer and Distributor Dynamics
The packager of MAS-ER Capsules, Sandoz Inc, plays a crucial role in determining the drug's pricing and availability. The company's strategies, including production costs, distribution networks, and pricing policies, will influence the market price of the drug[1].
Key Takeaways
- Price Erosion: Expect mid-single-digit percent annual price erosion due to market competition.
- Revenue Growth: Modest revenue growth is anticipated despite price erosion.
- Regulatory Risks: FDA inspections and price-fixing litigation can impact pricing stability.
- Market Competition: The ADHD treatment market is highly competitive, influencing pricing strategies.
- Demand and Market Size: Increasing demand for ADHD treatments supports revenue growth.
Frequently Asked Questions
Q: What is the NDC code 0781-2329 for?
A: The NDC code 0781-2329 is for MAS-ER Capsules, a medication used to treat attention deficit hyperactivity disorder (ADHD) in adults and pediatric patients 6 years and older.
Q: What are the key ingredients in MAS-ER Capsules?
A: The key ingredients are dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate.
Q: What is the DEA schedule for MAS-ER Capsules?
A: MAS-ER Capsules are classified as a Schedule CII controlled substance.
Q: How does the generic drug market impact the pricing of MAS-ER Capsules?
A: The generic drug market influences pricing through mid-single-digit percent annual price erosion and modest revenue growth.
Q: What regulatory factors could impact the pricing of MAS-ER Capsules?
A: FDA inspections of manufacturing facilities and price-fixing litigation are potential regulatory risks that could impact pricing stability.
Sources
- DailyMed: DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE- dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, and amphetamine sulfate capsule, extended release.
- Oregon Drug Price Transparency Program: Prescription Drug Price Transparency Results and Recommendations 2022.
- S&P Global: Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures.
