Introduction
Phenobarbital, a barbiturate with sedative and anticonvulsant properties, is a long-standing medication in the pharmaceutical market. This analysis will delve into the market dynamics, pricing, and projections for Phenobarbital, specifically focusing on the product identified by the National Drug Code (NDC) 75826-141.
Market Overview
Phenobarbital is classified as a human prescription drug, marketed by Winder Laboratories, LLC. It is available in various strengths, including the 64.8 mg (1 grain) tablet, which is the focus of this analysis[1][4].
Current Market Status
Phenobarbital is an unapproved drug other than those approved by the FDA, but it is still widely used due to its established efficacy and safety profile. The drug is primarily used as a sedative or anticonvulsant, and its market is relatively stable due to its long history of use.
Pricing
The pricing of Phenobarbital tablets can vary based on several factors, including the strength, dosage form, and package size. However, specific pricing data for NDC 75826-141 is not readily available in the public domain. Generally, barbiturates like Phenobarbital tend to be less expensive compared to newer medications due to their generic status and long market presence.
Market Trends
The pharmaceutical market is dynamic, with trends often influenced by regulatory changes, patent expirations, and the introduction of new therapies. Here are some key trends that could impact the market for Phenobarbital:
Generic Competition
Phenobarbital, being a generic drug, faces competition from other generic manufacturers. This competition can lead to price pressures, as multiple manufacturers vie for market share[5].
Regulatory Environment
The FDA's regulatory environment can affect the market. For instance, changes in drug listing obligations or compliance requirements can impact the availability and pricing of the drug[5].
Therapeutic Alternatives
The development and approval of new anticonvulsants and sedatives can influence the demand for Phenobarbital. However, due to its well-established use and safety profile, Phenobarbital remains a viable option for many patients.
Price Projections
Given the stable demand and generic nature of Phenobarbital, price projections are likely to be modest. Here are some key points to consider:
Stability in Pricing
Phenobarbital prices are generally stable due to its long-standing presence in the market and the lack of significant new competitors.
Impact of Generic Competition
The presence of multiple generic manufacturers can keep prices competitive. However, since Phenobarbital is already a generic drug, significant price drops are unlikely.
Regulatory and Market Factors
Any changes in regulatory requirements or market conditions, such as shifts in demand or supply chain disruptions, could potentially impact pricing. However, these factors are typically short-term and do not significantly alter long-term price projections.
Conclusion
Phenobarbital, identified by NDC 75826-141, operates within a stable market segment. Here are the key takeaways:
- Stable Demand: Phenobarbital continues to be used for its sedative and anticonvulsant properties.
- Generic Competition: The presence of multiple generic manufacturers maintains competitive pricing.
- Regulatory Stability: The FDA's regulatory environment does not currently indicate significant changes that would impact Phenobarbital's market.
- Price Projections: Prices are expected to remain stable with minimal fluctuations due to the drug's generic status and established market presence.
Key Takeaways
- Market Stability: The market for Phenobarbital is relatively stable.
- Generic Pricing: Prices are influenced by generic competition but remain stable.
- Regulatory Factors: No significant regulatory changes are expected to impact the market.
- Therapeutic Alternatives: New therapies may influence demand but are unlikely to significantly impact Phenobarbital's market share.
FAQs
Q: What is the primary use of Phenobarbital?
A: Phenobarbital is primarily used as a sedative or anticonvulsant.
Q: Who is the labeler for NDC 75826-141?
A: The labeler for NDC 75826-141 is Winder Laboratories, LLC.
Q: What is the DEA schedule for Phenobarbital?
A: Phenobarbital is classified as a DEA Schedule CIV drug.
Q: How does generic competition affect the pricing of Phenobarbital?
A: Generic competition helps maintain competitive pricing for Phenobarbital, keeping prices relatively stable.
Q: Are there any significant price projections for Phenobarbital in the near future?
A: No, significant price changes are not anticipated due to the stable market and generic nature of the drug.
Sources
- FDA.report: NDC 75826-141 Oral Tablet Phenobarbital Drug Codes.
- Missouri Department of Social Services: MISSOURI SPECIALTY MAC NAME OF DRUG Strength NDC Price Effective January 1, 2023.
- Drug Development & Delivery: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
- DailyMed: Label: PHENOBARBITAL tablet.
- FDA: National Drug Code Database Background Information.
