Introduction to NDC 62332-0159
The National Drug Code (NDC) 62332-0159 corresponds to Pramipexole Dihydrochloride, a medication manufactured by Alembic Pharmaceuticals Inc. This drug is used primarily for the treatment of Parkinson's disease and restless legs syndrome.
Market Overview
Prescription Drug Market Growth
The overall prescription drug market is expected to grow at a Compound Annual Growth Rate (CAGR) of 9% through 2030. This growth is driven by increasing demand for medications, advancements in healthcare, and an aging population[5].
Specific Market for Pramipexole Dihydrochloride
Pramipexole Dihydrochloride is part of the dopamine agonist class, which is a significant segment within the neurology and psychiatry drug markets. The demand for dopamine agonists is steady due to the chronic nature of Parkinson's disease and restless legs syndrome.
Pricing Trends
Current Pricing
As of the latest available data, the pricing for Pramipexole Dihydrochloride (NDC 62332-0159) can vary based on the dosage and packaging. However, specific price data for this NDC is not readily available in the provided sources. For context, prices of similar medications can fluctuate based on market conditions, competition, and regulatory changes.
Historical Price Movements
While specific historical price data for NDC 62332-0159 is not provided, it is common for generic medications like Pramipexole Dihydrochloride to experience price stability or gradual decreases over time due to competition from other generic manufacturers. For example, prices for other medications have shown a trend of slight decreases or stability in recent months[5].
Regulatory Environment
FDA Oversight
The FDA's National Drug Code Directory includes information about finished drug products, including Pramipexole Dihydrochloride. Manufacturers like Alembic Pharmaceuticals Inc. must comply with FDA regulations, including product listing and reporting requirements[1].
Compliance and Reporting
Drug establishments, including those producing Pramipexole Dihydrochloride, are required to provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed in commercial distribution in the U.S. This ensures that the drug meets safety and efficacy standards.
Market Drivers and Barriers
Drivers
- Increasing Prevalence of Parkinson's Disease and Restless Legs Syndrome: The growing incidence of these conditions drives the demand for effective treatments like Pramipexole Dihydrochloride.
- Generic Competition: The presence of multiple generic manufacturers can lead to competitive pricing, making the drug more accessible to patients.
- Advancements in Healthcare: Improvements in diagnostic techniques and treatment protocols can increase the prescription rate of this medication.
Barriers
- Regulatory Hurdles: Strict FDA regulations and the need for continuous compliance can increase costs and complexity for manufacturers.
- Patent Expirations and Generic Entry: While generic competition can drive down prices, it also increases market competition, potentially affecting the market share of individual manufacturers.
- Economic Factors: Economic downturns or changes in healthcare policies can impact the affordability and accessibility of medications.
Price Projections
Short-Term Projections
Given the stable demand for Pramipexole Dihydrochloride and the competitive nature of the generic drug market, it is likely that prices will remain relatively stable in the short term. Any significant price movements would be influenced by changes in raw material costs, manufacturing efficiencies, or regulatory changes.
Long-Term Projections
In the long term, the price of Pramipexole Dihydrochloride is expected to follow the general trend of the prescription drug market, with a potential for slight decreases due to increased competition and market pressures. The overall market growth of 9% CAGR through 2030 suggests that while the price per unit might stabilize or decrease slightly, the total market value for this medication could still increase due to growing demand.
Key Takeaways
- Stable Demand: The chronic nature of Parkinson's disease and restless legs syndrome ensures a steady demand for Pramipexole Dihydrochloride.
- Regulatory Compliance: Manufacturers must adhere to FDA regulations, which can impact pricing and market dynamics.
- Generic Competition: Multiple generic manufacturers can drive competitive pricing.
- Market Growth: The overall prescription drug market is expected to grow, influencing the market value of this medication.
FAQs
What is the primary use of Pramipexole Dihydrochloride?
Pramipexole Dihydrochloride is primarily used for the treatment of Parkinson's disease and restless legs syndrome.
Who manufactures Pramipexole Dihydrochloride with the NDC 62332-0159?
Alembic Pharmaceuticals Inc. manufactures Pramipexole Dihydrochloride with the NDC 62332-0159.
What is the expected growth rate of the prescription drug market through 2030?
The prescription drug market is expected to grow at a CAGR of 9% through 2030.
How does FDA regulation impact the pricing of Pramipexole Dihydrochloride?
FDA regulations ensure that the drug meets safety and efficacy standards, but compliance costs can influence pricing.
What are the key drivers of the market for Pramipexole Dihydrochloride?
Key drivers include the increasing prevalence of Parkinson's disease and restless legs syndrome, generic competition, and advancements in healthcare.
Sources
- FDA's National Drug Code Directory - FDA
- MISSOURI SPECIALTY MAC NAME OF DRUG Strength NDC Price - Missouri Department of Social Services
- Antimicrobial Drugs Market Returns Analysis - ASPE
- Alembic Pharmaceuticals Inc. - List of Drugs - Find-A-Code
- Latest drug prices and trends for NDC 00054-0319 - DrugPatentWatch
