Introduction
The NDC (National Drug Code) 00591-2640 corresponds to Butalbital, Acetaminophen, and Caffeine Capsules USP, a medication manufactured by Actavis Pharma, Inc. This drug is commonly used for the treatment of tension headaches and is classified as a controlled substance due to its butalbital component.
Market Overview
The pharmaceutical market, particularly for generic and controlled substances, is subject to various factors that influence pricing and demand.
Generic Drug Market
The generic drug market has seen significant fluctuations in prices. According to the Oregon Prescription Drug Price Transparency Program, the median price increase for generic drugs was 19.9% in 2022, with some drugs experiencing much higher increases[2][4].
Specific Drug Analysis: NDC 00591-2640
Current Pricing
As of the latest available data, the pricing for Butalbital, Acetaminophen, and Caffeine Capsules USP (NDC 00591-2640) is influenced by several factors including production costs, market competition, and regulatory requirements. The Wholesale Acquisition Cost (WAC) for this drug can vary, but it generally falls within a range that reflects its classification as a controlled substance and its generic status.
Price Trends
Historically, generic drugs have experienced significant price volatility. For instance, a generic naproxen manufactured by Hikma Pharmaceuticals saw a 2,527% price increase from $34.13 in 2012 to $896.44 in 2021[2]. While such extreme increases are rare, they highlight the potential for substantial price changes in the generic drug market.
Regulatory Environment
The regulatory landscape plays a crucial role in drug pricing. Programs like the Oregon Drug Price Transparency Program aim to provide more transparency into drug pricing and the reasons behind price increases. However, the quality of information submitted by manufacturers can be variable, making it challenging to determine the exact reasons for price changes[2][4].
Market Competition
Competition in the generics market can significantly impact pricing. For example, the WAC prices for generic fingolimod, a drug used for multiple sclerosis, were reduced by 84% to 97% due to competition among manufacturers[4].
Price Projections
Short-Term Projections
Given the current trends, it is likely that the price of Butalbital, Acetaminophen, and Caffeine Capsules USP will continue to experience moderate increases, potentially in line with the median price increase for generic drugs, which was around 20% in recent years[2][4].
Long-Term Projections
In the long term, the biopharma and biotech industries are expected to see significant growth and innovation, driven by advancements in clinical trial designs, regulatory frameworks, and the adoption of precision medicine and AI/ML technologies[3]. While these trends may not directly impact the pricing of a specific generic drug like NDC 00591-2640, they could influence the broader market dynamics and potentially lead to more stable or even reduced prices due to increased efficiency and competition.
Consumer and Market Impact
Affordability
The affordability of prescription drugs remains a critical issue. High and unpredictable price increases can make necessary medications unaffordable for many consumers. Initiatives like the Oregon Prescription Drug Price Transparency Program and the California-based CalRx project aim to address these issues by promoting transparency and reducing costs[4].
Market Demand
The demand for Butalbital, Acetaminophen, and Caffeine Capsules USP is likely to remain steady due to its use in treating tension headaches, a common condition. However, changes in pricing can affect patient adherence and healthcare outcomes.
Key Takeaways
- Price Volatility: Generic drugs, including NDC 00591-2640, can experience significant price increases.
- Regulatory Impact: Transparency programs and regulatory changes can influence pricing and market dynamics.
- Market Competition: Increased competition among manufacturers can lead to reduced prices.
- Long-Term Trends: Innovations in the biopharma and biotech sectors may lead to more efficient and cost-effective drug development.
FAQs
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What is NDC 00591-2640 used for?
- NDC 00591-2640 is used for the treatment of tension headaches and is a combination of butalbital, acetaminophen, and caffeine.
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Why do generic drug prices fluctuate so much?
- Generic drug prices can fluctuate due to factors such as production costs, market competition, and regulatory requirements.
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How does the regulatory environment affect drug pricing?
- Regulatory programs aim to provide transparency into pricing and can influence market dynamics, but the quality of information submitted by manufacturers can be variable.
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Can competition among manufacturers reduce drug prices?
- Yes, increased competition among manufacturers can lead to reduced prices, as seen with generic fingolimod.
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What are the long-term projections for the biopharma and biotech industries?
- The biopharma and biotech industries are expected to see significant growth and innovation, driven by advancements in clinical trial designs, regulatory frameworks, and the adoption of precision medicine and AI/ML technologies.
Sources
- Table of Exempted Prescription Products - Drug Enforcement Administration Diversion Control Division[1].
- Prescription Drug Price Transparency Results and Recommendations - Oregon Department of Consumer and Business Services[2].
- 5 Predictions for the Biopharma and Biotech Industries in 2025 - TFS CRO[3].
- Prescription Drug Price Transparency Program results and recommendations - Oregon Department of Consumer and Business Services[4].
