Market Analysis and Price Projections for the Drug NDC: 0378-6993
Introduction
The National Drug Code (NDC) 0378-6993 corresponds to Levalbuterol inhalation solution, a concentrate used for the treatment or prevention of bronchospasm in adults, adolescents, and children 6 years of age and older. This analysis will delve into the market dynamics, pricing trends, and projections for this specific drug.
Market Overview
Levalbuterol, marketed under various brand names, is a key medication in the management of asthma and chronic obstructive pulmonary disease (COPD). The market for bronchodilators, including levalbuterol, is significant due to the high prevalence of respiratory diseases.
Demand and Supply
The demand for levalbuterol is driven by the increasing incidence of asthma and COPD, as well as the need for effective bronchodilators. Supply is maintained by several pharmaceutical companies, including Mylan Pharmaceuticals Inc., which is the packager for the NDC 0378-6993[4].
Pricing Trends
Historical Price Changes
Pricing trends for prescription drugs, including levalbuterol, have been marked by periodic increases. According to the ASPE issue brief, most prescription drug price increases occur in January and July each year. In January 2022, the average price increase was nearly $150 per drug (10.0 percent), and in July 2022, it was $250 (7.8 percent)[2].
Specific Price Changes for NDC 0378-6993
While the specific price changes for NDC 0378-6993 are not detailed in the available sources, it is reasonable to assume that this drug follows similar trends to other prescription drugs. Significant price increases, defined as changes greater than $20 per package or 10 percent within a 12-month period, or any change greater than $500 per package, are common in the pharmaceutical industry[2].
Impact of Inflation
The Consumer Price Index (CPI) for all Urban Consumers increased by 8.5 percent between July 2021 and July 2022, which can influence drug price increases. However, not all price increases exceed the rate of inflation; in July 2022, 124 of the 601 increases exceeded general inflation[2].
Regulatory Environment
FDA and NDC Directory
The FDA's National Drug Code Directory includes information on finished drug products, unfinished drugs, and compounded drug products. The NDC Directory is updated daily and contains product listing data submitted by labelers, including manufacturers, repackagers, and relabelers[1][3].
Compliance and Reporting
Drug establishments, including those manufacturing levalbuterol, must provide the FDA with a current list of all drugs manufactured, prepared, propagated, compounded, or processed for sale in the U.S. This includes updating drug listing data in June and December each year[1][3].
Market Projections
Price Projections
Given the historical trends, it is likely that the price of levalbuterol (NDC 0378-6993) will continue to experience periodic increases, particularly in January and July. The average price increase could range from 7.8 percent to 10.0 percent, aligning with industry-wide trends.
Market Growth
The market for bronchodilators is expected to grow due to increasing awareness and diagnosis of respiratory diseases. This growth, combined with the necessity of levalbuterol in treatment protocols, suggests a stable or increasing demand for the drug.
Competitive Landscape
Market Competition
The market for levalbuterol is competitive, with multiple manufacturers and generic versions available. Mylan Pharmaceuticals Inc., the packager for NDC 0378-6993, competes with other pharmaceutical companies to maintain market share. Competition can influence pricing strategies, but regulatory requirements and market demand also play significant roles[4].
Consumer and Payer Impact
Affordability and Access
High prescription drug prices, including those for levalbuterol, create affordability challenges for patients and the healthcare system. Significant price increases can lead to higher copayments and coinsurance, affecting patient access to essential medications[2].
Regulatory Measures
Some states and regulatory bodies are implementing measures to monitor and control drug price increases. For example, Nevada's Essential Drug List tracks price increases for essential drugs, including those for asthma and diabetes, and requires reports from labelers and pharmacy benefit managers[5].
Key Takeaways
- Pricing Trends: Levalbuterol (NDC 0378-6993) is likely to follow industry-wide pricing trends with periodic increases, particularly in January and July.
- Regulatory Environment: The FDA's NDC Directory and compliance requirements ensure that drug establishments update their listing data regularly.
- Market Projections: The market for bronchodilators, including levalbuterol, is expected to grow due to increasing demand for respiratory disease treatments.
- Competitive Landscape: The market is competitive, with multiple manufacturers influencing pricing strategies.
- Consumer and Payer Impact: High drug prices affect patient affordability and access, prompting regulatory measures to monitor and control price increases.
FAQs
What is the National Drug Code (NDC) and how is it used?
The NDC is a unique, three-segment number that identifies drug products. It is used by the FDA to track and regulate drug products in the U.S.[1][3].
How often do prescription drug prices increase?
Prescription drug prices, including those for levalbuterol, typically increase in January and July each year[2].
What factors influence the price of levalbuterol?
Factors such as inflation, regulatory requirements, market demand, and competition influence the price of levalbuterol[2].
How does the FDA monitor drug price increases?
The FDA does not directly monitor drug price increases but ensures that drug establishments comply with listing and reporting requirements. Price monitoring is often done by other regulatory bodies and research organizations[1][3].
What are the implications of high drug prices for patients and the healthcare system?
High drug prices create affordability challenges for patients and the healthcare system, affecting access to essential medications and increasing healthcare costs[2].
Sources
- FDA's National Drug Code Directory - FDA
- Price Increases for Prescription Drugs, 2016-2022 - ASPE
- National Drug Code Database Background Information - FDA
- Label: LEVALBUTEROL solution, concentrate - DailyMed
- 2020 Essential Drug List - Department of Health and Human Services, Nevada
