Last updated: January 1, 2025
Introduction
Phenobarbital, a barbiturate with sedative and anticonvulsant properties, is widely used in medical practice. This article will delve into the market analysis and price projections for Phenobarbital, specifically focusing on the product with the NDC code 75826-138.
Market Overview
Phenobarbital is classified as a human prescription drug and is marketed by Winder Laboratories, LLC. Here are some key points about its market presence:
- Product Type and Route of Administration: Phenobarbital is available in oral tablet form[1][4][5].
- Marketing Category: It falls under the category of "unapproved drug other," indicating it is not a new drug application (NDA) but is still available for prescription use[1][4][5].
- DEA Schedule: Phenobarbital is listed as a Schedule IV controlled substance, which means it has a lower potential for abuse compared to Schedule III substances but can still lead to physical dependence[1][4][5].
Market Trends and Competition
The pharmaceutical market is highly competitive, and several factors influence the pricing and market share of drugs like Phenobarbital.
- Generic Market: Phenobarbital is a generic drug, which generally means it is priced lower than its branded counterparts. The presence of multiple generic versions from different manufacturers contributes to competitive pricing[1][4][5].
- Usage and Demand: As a sedative and anticonvulsant, Phenobarbital has a steady demand. However, its use has been declining with the advent of newer, safer alternatives. This trend can impact pricing and market share[4].
Price Projections
Price projections for Phenobarbital are influenced by several factors, including production costs, regulatory changes, and market competition.
- Current Pricing: The current price of Phenobarbital tablets varies based on the dosage and packaging. For example, a 30 mg tablet (NDC 75826-138) is generally priced lower than higher dosage forms[1][4][5].
- Regulatory Changes: The FDA's proposed rule to standardize the National Drug Code (NDC) to a 12-digit format may impact labeling and distribution costs, which could be reflected in the pricing of the drug. However, this is more of a logistical change rather than a direct price influencer[2].
Market Analysis by Dosage
Phenobarbital is available in various dosages, each with its own market dynamics.
- Dosage Forms: Phenobarbital tablets are available in dosages ranging from 15 mg to 100 mg. The 30 mg tablet (NDC 75826-138) is one of the commonly prescribed dosages[1][4][5].
- Pricing by Dosage: Generally, higher dosages are priced higher due to the increased amount of active ingredient. However, the price per unit may decrease with larger packaging quantities[1][4][5].
Impact of Generic Competition
Generic competition plays a significant role in the pricing of Phenobarbital.
- Multiple Manufacturers: Several manufacturers produce Phenobarbital, leading to competitive pricing. This competition ensures that the drug remains affordable for patients[1][4][5].
- Price Stability: The presence of multiple generic versions tends to stabilize prices, as manufacturers compete to offer the best value to consumers and healthcare providers.
Future Market Outlook
The future market outlook for Phenobarbital is influenced by several factors, including changes in medical practices and regulatory environments.
- Declining Use: With the development of newer anticonvulsants and sedatives, the use of Phenobarbital is expected to decline. This could lead to a reduction in demand and potentially lower prices[4].
- Regulatory Compliance: Manufacturers must comply with FDA regulations, including the proposed changes to NDC formats. This could lead to short-term costs associated with labeling updates but is unlikely to significantly impact long-term pricing[2].
Key Takeaways
- Stable Pricing: Due to generic competition, Phenobarbital prices are expected to remain relatively stable.
- Declining Demand: The use of Phenobarbital is expected to decline with the advent of newer medications.
- Regulatory Compliance: Manufacturers will need to adapt to FDA changes, but this is unlikely to significantly impact pricing.
FAQs
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What is the primary use of Phenobarbital?
Phenobarbital is primarily used as a sedative or anticonvulsant.
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Who is the manufacturer of Phenobarbital with NDC 75826-138?
The manufacturer is Winder Laboratories, LLC.
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What is the DEA schedule for Phenobarbital?
Phenobarbital is classified as a Schedule IV controlled substance.
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How does the FDA's proposed NDC format change affect Phenobarbital pricing?
The proposed change to a 12-digit NDC format is more of a logistical change and is unlikely to significantly impact the pricing of Phenobarbital.
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What is the expected market trend for Phenobarbital in the future?
The use of Phenobarbital is expected to decline with the advent of newer medications, which could lead to a reduction in demand and potentially lower prices.
Sources
- FDA.report: NDC 75826-138 Oral Tablet Phenobarbital Drug Codes.
- FDA: Future Format of the National Drug Code.
- Drug-dev.com: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
- DailyMed: Label: PHENOBARBITAL tablet.
- FDA.report: NDC 75826-141 Oral Tablet Phenobarbital Drug Codes.
