Introduction
Hyoscyamine sulfate, identified by the National Drug Code (NDC) 62135-512, is a human prescription drug manufactured by Chartwell RX, LLC. This article provides a comprehensive market analysis and price projections for this medication.
Drug Overview
Hyoscyamine sulfate is a generic prescription drug available in tablet form. It is used to treat various conditions, including gastrointestinal disorders and muscle spasms. Here are some key details about the drug:
- Proprietary Name: Hyoscyamine sulfate
- Generic Name: Hyoscyamine Sulfate
- Dosage Form: Tablet
- Route of Administration: Oral
- Labeler Name: Chartwell RX, LLC
- Marketing Start Date: November 17, 2022[1].
Market Context
The pharmaceutical market is highly dynamic, with prices influenced by multiple factors including research and development costs, manufacturing expenses, market competition, and regulatory environments.
Price Trends in the Pharmaceutical Industry
Recent trends indicate significant price increases in the pharmaceutical sector. For instance, the median price increase for generic drugs was 19.9% in 2022, while brand-name drugs saw a median increase of 13.4%[2].
Specific Price Increases
Some generic drugs have experienced extraordinary price hikes. For example, a generic version of naproxen saw a 2,527% price increase from $34.13 in 2012 to $896.44 in 2021[2]. Such drastic changes highlight the volatility in drug pricing.
Pricing Mechanisms
Drug prices are influenced by several factors:
- Perceived Value: The drug's ease of use, novelty, and safety compared to competitors[5].
- Therapeutic Alternatives: Costs of alternative treatments, such as other drugs, surgery, or medical devices[5].
- Patient Market: Size and characteristics of the patient population[5].
- Research and Development: Costs associated with developing the drug[5].
- Reimbursement: Amounts paid by third-party payers like insurance companies[5].
Current Pricing for Hyoscyamine Sulfate
As of the latest available data, the pricing for Hyoscyamine sulfate (NDC 62135-512) is not explicitly stated. However, given its status as a generic drug, it is generally less expensive than brand-name counterparts.
Price Projections
General Trends
Generic drugs, like Hyoscyamine sulfate, tend to follow broader industry trends. Here are some projections based on recent data:
- Median Price Increases: Generic drugs have seen median price increases of around 19.9% in recent years. This trend may continue, although the rate of increase can vary[2].
Specific Projections for Hyoscyamine Sulfate
Given the lack of specific historical price data for NDC 62135-512, projections must be based on industry averages and trends.
- Short-Term Projections: In the short term, Hyoscyamine sulfate prices might see a moderate increase, potentially in line with the median increase for generic drugs.
- Long-Term Projections: Over the long term, prices could stabilize or continue to rise, depending on factors such as changes in manufacturing costs, market competition, and regulatory changes.
Example of Price Volatility
To illustrate the potential for price volatility, consider the example of Paliperidone ER 9 MG Tablet (NDC 72819-0160), which saw significant price fluctuations over a few months. For instance, the price per unit varied from $1.44826 to $2.39324 between July 2024 and August 2024[3].
Regulatory Environment
The FDA's National Drug Code Directory plays a crucial role in tracking and regulating drug prices. Here are some key points:
- NDC Directory: Contains information on all finished and unfinished drugs, including compounded drug products. This directory helps in monitoring price changes and ensuring compliance with FDA regulations[4].
- Marketing Start and End Dates: The directory includes the marketing start and end dates, which can impact the pricing strategy of the drug[4].
Conclusion
The pricing of Hyoscyamine sulfate (NDC 62135-512) is influenced by a complex array of factors, including industry trends, regulatory environments, and market dynamics. While specific price projections are challenging without historical data, it is clear that generic drugs like Hyoscyamine sulfate are subject to the broader trends of price increases seen in the pharmaceutical industry.
Key Takeaways
- Generic Drug Pricing: Hyoscyamine sulfate, as a generic drug, is generally less expensive than brand-name drugs but can still see significant price increases.
- Industry Trends: Median price increases for generic drugs have been around 19.9% in recent years.
- Regulatory Impact: The FDA's National Drug Code Directory and other regulatory mechanisms play a crucial role in monitoring and influencing drug prices.
- Market Volatility: Prices can fluctuate significantly over short periods due to various market and regulatory factors.
FAQs
Q: What is the current price of Hyoscyamine sulfate (NDC 62135-512)?
A: The current price of Hyoscyamine sulfate (NDC 62135-512) is not explicitly stated in the available data. However, it is generally less expensive than brand-name counterparts.
Q: What factors influence the price of Hyoscyamine sulfate?
A: The price is influenced by factors such as perceived value, therapeutic alternatives, patient market size, research and development costs, and reimbursement amounts.
Q: How do regulatory environments impact drug pricing?
A: Regulatory environments, such as the FDA's National Drug Code Directory, help in monitoring and ensuring compliance with pricing regulations, which can impact the pricing strategy of the drug.
Q: Can we expect significant price increases for generic drugs like Hyoscyamine sulfate?
A: Yes, generic drugs can see significant price increases, as evidenced by recent trends showing median price increases of around 19.9%.
Q: How often are prices updated in the FDA's National Drug Code Directory?
A: The FDA's National Drug Code Directory is updated daily to reflect changes in drug listings and pricing[4].
Sources
- FDA.report: NDC 62135-512 Oral Tablet Hyoscyamine sulfate Drug.
- Oregon Department of Consumer and Business Services: Prescription Drug Price Transparency Results and Recommendations.
- DrugPatentWatch: Latest drug prices and trends for NDC 72819-0160.
- FDA: National Drug Code Directory.
- GAO: Brand-Name Prescription Drug Pricing.
