Market Analysis and Price Projections for the Drug NDC: 57664-0167
Introduction
The pharmaceutical industry is a complex and dynamic sector, influenced by a variety of factors including regulatory changes, technological advancements, and market demand. This article focuses on the market analysis and price projections for the drug identified by the National Drug Code (NDC) 57664-0167, which is associated with a specific formulation of promethazine hydrochloride and codeine phosphate syrup.
Drug Overview
The NDC 57664-0167 corresponds to a syrup formulation containing promethazine hydrochloride and codeine phosphate, marketed by Sun Pharmaceutical Industries, Inc.[1].
- Ingredients and Appearance: This syrup contains 6.25 mg of promethazine hydrochloride and 10 mg of codeine phosphate per 5 mL, with an alcohol content of 7% v/v.
- Packaging: It is available in a 16 fl. Oz. (473 mL) bottle.
- DEA Schedule: This drug is classified as a Schedule CV controlled substance.
Market Analysis
Current Market Dynamics
The market for promethazine hydrochloride and codeine phosphate syrup is characterized by several key factors:
- Generic Competition: As a generic formulation, the pricing of this drug is generally more stable compared to brand-name drugs. However, the presence of multiple generic manufacturers can lead to competitive pricing pressures[2].
- Regulatory Environment: The FDA's oversight and the DEA's scheduling play crucial roles in the distribution and pricing of this controlled substance. Regulatory changes, such as those affecting upper payment limits, could impact pricing strategies[2].
Historical Pricing
Historically, generic drugs have experienced significant price volatility. While the specific historical pricing data for NDC 57664-0167 is not readily available, it is important to note that generic drugs can see dramatic price changes due to various market and regulatory factors[2].
Price Projections
Price Stability
Given the generic nature of the drug, its pricing is likely to remain relatively stable. However, several factors can influence price fluctuations:
- Raw Material Costs: Changes in the costs of raw materials can impact the production costs and subsequently the pricing of the drug.
- Manufacturing Efficiencies: Improvements in manufacturing processes, potentially driven by technological advancements like AI and data analytics, could lead to cost savings and stable or reduced prices[4].
- Market Competition: The presence of multiple generic manufacturers ensures a competitive market, which generally keeps prices in check[2].
Impact of Regulatory Changes
Regulatory changes can significantly influence drug pricing. For instance, proposed upper payment limits for certain drugs could cap the maximum price that can be charged, potentially affecting the pricing strategy for this and other generic medications[2].
Technological Impact
The integration of technologies such as AI and data analytics is expected to boost operational efficiencies in the pharmaceutical industry. These advancements could lead to more efficient production and distribution processes, potentially stabilizing or reducing costs for drugs like the one associated with NDC 57664-0167[3].
Market Competition and Generics
The entry of generic versions of brand-name drugs often leads to a decrease in overall market prices. For promethazine hydrochloride and codeine phosphate syrup, the presence of multiple generic manufacturers ensures a competitive market, which helps keep prices stable and competitive[2].
Future Projections
While specific price projections for NDC 57664-0167 are not readily available, the overall trend for generic drugs suggests that prices may remain relatively stable or see moderate increases. Any significant changes in the supply chain, regulatory environment, or market demand could impact pricing.
Key Takeaways
- NDC and Regulatory Oversight: The FDA's NDC Directory plays a crucial role in tracking and managing drug products, ensuring compliance and transparency[5].
- Market Trends: The pharmaceutical industry is experiencing significant growth driven by technological advancements and evolving regulatory frameworks[3].
- Price Transparency: Regulatory programs aim to improve price transparency, but challenges in data quality and compliance persist[2].
- Pricing Stability: Generic drugs like promethazine hydrochloride and codeine phosphate syrup tend to have more stable pricing compared to brand-name drugs[2].
- Regulatory Impact: Proposed regulatory changes could affect pricing strategies for generic medications[2].
- Market Competition: Multiple generic manufacturers ensure a competitive market, keeping prices in check[2].
Illustrative Statistics
- Generic Drug Pricing: The median price increase for generic drugs has been around 19.9%, although this can vary widely depending on the specific drug and market conditions[2].
- Regulatory Changes: Nearly half of life sciences executives expect pricing and access to significantly affect their strategies in 2025, highlighting the ongoing impact of regulatory changes on drug pricing[3].
Quotes from Industry Experts
- "We are full of expectations for personalized medicine," explained a senior vice president of a small German pharma company. "With advances in genomics and biomarkers, we can provide patients with more precise treatment options. This not only improves efficacy but also significantly reduces side-effects, allowing patients to have a better treatment experience."[3]
Highlight
"The biopharma industry is facing a substantial loss of exclusivity, with more than US$300 billion in sales at risk through 2030 due to expiring patents on high-revenue products. This looming patent expiration is likely to drive interest in mergers and acquisitions, with 77% of surveyed executives expecting M&A to increase in 2025."[3]
FAQs
What is the NDC code 57664-0167 associated with?
The NDC code 57664-0167 is associated with a syrup formulation containing promethazine hydrochloride and codeine phosphate, marketed by Sun Pharmaceutical Industries, Inc.[1].
What are the key ingredients in the syrup associated with NDC 57664-0167?
The syrup contains 6.25 mg of promethazine hydrochloride and 10 mg of codeine phosphate per 5 mL, with an alcohol content of 7% v/v[1].
How does the regulatory environment impact the pricing of NDC 57664-0167?
The FDA's oversight and the DEA's scheduling play crucial roles in the distribution and pricing of this controlled substance. Regulatory changes, such as those affecting upper payment limits, could impact pricing strategies[2].
What is the expected price stability for generic drugs like NDC 57664-0167?
Generic drugs like promethazine hydrochloride and codeine phosphate syrup tend to have more stable pricing compared to brand-name drugs, although they can still experience moderate price increases due to various market and regulatory factors[2].
How do technological advancements impact the pricing of drugs like NDC 57664-0167?
Technological advancements such as AI and data analytics can lead to more efficient production and distribution processes, potentially stabilizing or reducing costs for drugs like the one associated with NDC 57664-0167[3].
Sources
- Pharmacompass: NDC Code 57664-185-34 - Codeine Phosphate
- Drug Patent Watch: Latest pharmaceutical drug prices and trends for NDC 16714-0167
- Deloitte Insights: 2025 life sciences outlook
- Drug Patent Watch: Latest pharmaceutical drug prices and trends for NDC 00115-1325
- FDA: National Drug Code Directory
