Understanding the National Drug Code (NDC)
The National Drug Code (NDC) is a unique identifier assigned to each drug product, including the labeler, product, and package size. For the drug identified by NDC 51672-4186, this code corresponds to Felbamate Tablets USP, specifically the 600 mg formulation packaged by Taro Pharmaceuticals U.S.A., Inc.[3][4].
Drug Overview: Felbamate
Felbamate is an antiepileptic drug used in the treatment of seizures. It is available in tablet form and is known for its efficacy in managing certain types of epilepsy. However, it is associated with serious side effects, including a marked increase in the incidence of aplastic anemia, which limits its use to specific clinical scenarios[3][4].
Market Trends and Price Analysis
To analyze the market and price projections for Felbamate (NDC 51672-4186), several factors need to be considered:
Current Pricing
As of the latest available data, the pricing for Felbamate tablets can vary based on the vendor, package size, and other market factors. However, specific price data for NDC 51672-4186 is not readily available in the public domain. Generally, prices for generic medications like Felbamate tend to be more stable compared to brand-name drugs but can still fluctuate based on market demand and supply chain dynamics.
Market Dynamics
The pharmaceutical market is influenced by various factors, including regulatory changes, competition from biosimilars or generic alternatives, and overall healthcare expenditure trends. For instance, the rise of biosimilars is expected to impact the pricing of many pharmaceuticals, although Felbamate, being a generic drug, may not be directly affected by biosimilar competition[2].
Specialty Pharmaceuticals and Overall Market Outlook
While Felbamate is not classified as a specialty pharmaceutical, the broader pharmaceutical market is experiencing significant changes driven by specialty drugs. According to Vizient, Inc., the projected increase in drug prices, particularly for specialty pharmaceuticals, is expected to be around 3.8% due to factors such as the increasing utilization of weight loss drugs and the expansion of gene therapies[2].
Price Projections
Given the lack of specific price data for NDC 51672-4186, we can infer some trends from the broader market:
General Price Stability
Generic drugs like Felbamate typically experience less price volatility compared to brand-name or specialty drugs. However, they can still be affected by general market trends and supply chain disruptions.
Impact of Regulatory and Market Changes
Any significant changes in regulatory policies or market conditions, such as shifts in demand or supply chain issues, could impact the pricing of Felbamate. For example, if there is a shortage of raw materials or manufacturing disruptions, prices could rise.
Competition and Market Share
The presence of other antiepileptic drugs and potential new entrants in the market could influence the pricing strategy for Felbamate. However, since Felbamate is a well-established generic drug, it is less likely to see significant price fluctuations due to competition.
Challenges and Opportunities
Supply Chain Management
Managing pharmacy expenditures and strengthening the supply chain is crucial, especially given the challenges faced by hospitals in recent years, including drug shortages and rising costs[2].
Regulatory Compliance
Ensuring compliance with regulatory requirements and proper coding for reimbursement is essential for maintaining stable pricing and market access.
Key Takeaways
- Stable Pricing: Generic drugs like Felbamate generally experience stable pricing.
- Market Dynamics: Broader market trends, such as the rise of specialty pharmaceuticals, can indirectly influence the pricing environment.
- Regulatory Compliance: Adherence to regulatory requirements is critical for maintaining market stability.
- Supply Chain Management: Effective supply chain management is vital to mitigate the risk of shortages and price fluctuations.
FAQs
Q: What is the National Drug Code (NDC) and its significance?
A: The NDC is a unique identifier assigned to each drug product, including the labeler, product, and package size. It helps in tracking and managing drug products efficiently.
Q: What are the potential side effects of Felbamate?
A: Felbamate is associated with serious side effects, including a marked increase in the incidence of aplastic anemia.
Q: How do broader market trends affect the pricing of generic drugs like Felbamate?
A: While generic drugs are less affected by broader market trends compared to specialty drugs, they can still be influenced by general market conditions and supply chain dynamics.
Q: What role does regulatory compliance play in drug pricing?
A: Regulatory compliance is crucial for maintaining stable pricing and market access. Proper coding for reimbursement and adherence to regulatory requirements are essential.
Q: How can supply chain disruptions impact drug prices?
A: Supply chain disruptions, such as shortages of raw materials or manufacturing issues, can lead to price increases for drugs, including generic medications like Felbamate.
Sources
- DailyMed - Label: FELBAMATE tablet
- Vizient, Inc. - Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals
- DailyMed - Felbamate Tablets USP 400 mg and 600 mg
- DailyMed - Label: FELBAMATE tablet
"Many hospitals around the country experienced a challenging 2023, including drug shortages and rising drug costs," said Carina Dolan, associate vice president, clinical oncology, pharmacoeconomics and market insights, Vizient[2].