Drug Overview
The NDC code 00555-0972 corresponds to a medication containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate, manufactured by Teva Pharmaceuticals USA, Inc. This medication is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse[1].
Current Market Context
Pharmaceutical Industry Trends
The pharmaceutical industry is undergoing significant transformations driven by digital innovation, scientific advancements, and changing regulatory landscapes. In 2025, pricing and access to drugs are expected to be major concerns, with nearly half of C-suite executives anticipating these issues to significantly impact their strategies[3].
Generic and Biosimilar Competition
The market for the NDC 00555-0972 may face competition from generic versions, as the patent cliff looms large over the biopharma industry. More than $300 billion in sales are at risk through 2030 due to expiring patents on high-revenue products, which could lead to increased generic competition[3].
Price Transparency and Regulatory Oversight
Oregon Drug Price Transparency Program
The Oregon Drug Price Transparency Program provides insights into the pricing dynamics of prescription drugs. The program has highlighted significant price increases, with some generic drugs experiencing as much as a 2,527% increase in price. This variability in pricing underscores the need for transparency and regulatory oversight to understand the factors influencing drug prices[2].
Reporting Requirements and Compliance
Manufacturers, including Teva Pharmaceuticals, are required to report price increases and new high-cost drugs to regulatory bodies. However, the quality of information submitted varies widely, and compliance issues remain a challenge. Regulatory efforts aim to improve transparency across the pharmaceutical supply chain, including interactions with pharmacy benefit managers (PBMs) and other entities[2].
Price Projections for 2025
Overall Drug Price Inflation
For the period from January 1, 2025, to December 31, 2025, the overall drug price inflation rate is projected to be around 0%, according to the Vizient Pharmacy Market Outlook. However, this projection is general and may not reflect the specific dynamics of controlled substances like the one with NDC 00555-0972[4].
Specific Drug Price Trends
Given the high potential for abuse and the controlled nature of the drug, price fluctuations may be more stable compared to other pharmaceuticals. However, any significant changes in regulatory policies, such as the implementation of upper payment limits or increased transparency measures, could impact pricing.
Impact of Generic Competition
As patents expire and generic versions become more prevalent, the prices of branded drugs like the one with NDC 00555-0972 may face downward pressure. This competition could lead to more affordable options for consumers but may also affect the revenue streams of the original manufacturers.
Financial and Access Considerations
Cost to Consumers
The cost of prescription drugs, including those with NDC 00555-0972, is influenced by various factors such as list prices, markups, rebates, and discounts. Understanding these factors is crucial for developing policies to make drugs more affordable for consumers[2].
Healthcare Financial Models
The escalating costs of advanced treatments highlight the need for sustainable financial models in healthcare. The approval of high-cost gene therapies, for example, underscores the financial challenges faced by healthcare systems and the need for innovative pricing strategies[4].
Industry Outlook and Innovations
Digital Transformation and Innovation
The life sciences industry is poised for significant transformation in 2025, driven by digital advancements and scientific innovations. Technologies like gen AI and increased data use are expected to boost operational efficiencies and drive breakthrough innovations, which could indirectly influence the pricing and accessibility of drugs[3].
Personalized Medicine
Advances in genomics and biomarkers are enabling more precise treatment options, which could improve efficacy and reduce side effects. This shift towards personalized medicine may also impact the pricing strategies of pharmaceutical companies as they adapt to new therapeutic solutions[3].
Key Takeaways
- The NDC 00555-0972 corresponds to a controlled substance with a high potential for abuse.
- The pharmaceutical industry faces significant challenges related to pricing and access in 2025.
- Regulatory oversight and transparency measures are crucial for understanding and managing drug prices.
- Generic competition and patent expirations can significantly impact the pricing of branded drugs.
- Digital transformation and scientific innovations are driving changes in the life sciences industry.
Frequently Asked Questions (FAQs)
1. What is the NDC code 00555-0972 for?
The NDC code 00555-0972 is for a medication containing dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate.
2. Why is this drug classified as a Schedule CII controlled substance?
This drug is classified as a Schedule CII controlled substance due to its high potential for abuse and misuse.
3. How does the Oregon Drug Price Transparency Program affect drug pricing?
The Oregon Drug Price Transparency Program requires manufacturers to report price increases and new high-cost drugs, aiming to improve transparency and understand the factors influencing drug prices.
4. What are the projected price trends for pharmaceuticals in 2025?
The overall drug price inflation rate is projected to be around 0% for 2025, but specific trends may vary based on factors like generic competition and regulatory changes.
5. How does digital transformation impact the pharmaceutical industry?
Digital transformation, including the use of gen AI and increased data, is expected to boost operational efficiencies and drive breakthrough innovations in the pharmaceutical industry.
Sources:
- DailyMed. DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE tablet.
- Oregon Department of Consumer and Business Services. Prescription Drug Price Transparency Results and Recommendations 2022.
- Deloitte Insights. 2025 life sciences outlook.
- Vizient Inc. Pharmacy Market Outlook Summer 2024.
