Overview of the Drug
The drug with the National Drug Code (NDC) 51801-001 is Effer-K Orange, a human prescription drug manufactured by Nomax Inc. It is an effervescent tablet containing Potassium Bicarbonate as the active ingredient, with a strength of 977.5 mg per tablet[1].
Market Category and Approval Status
Effer-K Orange falls under the category of "UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER," indicating that it is not an FDA-approved drug but is still available on the market. This status can affect its pricing and market dynamics compared to approved drugs[1].
Historical Pricing Trends
While specific pricing data for NDC 51801-001 is not readily available in the provided sources, we can infer some trends from similar contexts:
- Price Inflation: Generally, drug prices are expected to rise due to inflation. For example, a projected 3.81% drug price inflation rate is anticipated in some sectors[5].
- Market Dynamics: The prices of unapproved drugs can be more volatile and less predictable compared to FDA-approved drugs. This volatility can be influenced by factors such as competition, regulatory changes, and market demand.
Factors Influencing Price Projections
Several factors can influence the price projections for Effer-K Orange:
Utilization and Demand
- Increased utilization of potassium bicarbonate products, especially in clinical settings, can drive up demand and potentially increase prices.
- Example: In 2023, overall pharmaceutical expenditures in the US grew 13.6% due to increased utilization, among other factors[3].
Regulatory Environment
- Changes in regulatory policies or legislation can impact the pricing of unapproved drugs. For instance, stricter regulations could lead to increased costs for manufacturers, which might be passed on to consumers.
- Example: The FDA's National Drug Code Directory includes information on all finished and unfinished drugs, which can influence pricing transparency and regulatory compliance[4].
Competition
- The presence of other potassium bicarbonate products or alternative treatments can affect pricing. If there are few competitors, manufacturers may have more flexibility to set higher prices.
- Example: The market for specialty and generic drugs is highly competitive, which can influence pricing strategies[3].
Economic Factors
- Economic conditions such as inflation and supply chain disruptions can impact the cost of production and distribution, leading to price increases.
- Example: A 3.81% drug price inflation rate is projected in some sectors, reflecting broader economic trends[5].
Price Projections
Given the lack of specific historical pricing data for NDC 51801-001, we must rely on general trends and factors influencing the pharmaceutical market:
- Short-Term Projections: For 2024, overall prescription drug spending is expected to rise by 10.0% to 12.0%. While this is a general trend, unapproved drugs like Effer-K Orange might experience more variability.
- Long-Term Projections: The ongoing increase in pharmaceutical expenditures, driven by factors like new drug approvals, patent expirations, and changes in utilization, suggests that prices for Effer-K Orange could continue to rise, albeit with some uncertainty due to its unapproved status.
Key Takeaways
- Market Volatility: Prices for unapproved drugs like Effer-K Orange can be more volatile due to regulatory and market uncertainties.
- Inflation and Utilization: General trends in pharmaceutical spending, including inflation and increased utilization, are likely to influence price increases.
- Regulatory Impact: Changes in FDA regulations or policies can affect the pricing and availability of unapproved drugs.
FAQs
Q: What is the active ingredient in Effer-K Orange?
A: The active ingredient in Effer-K Orange is Potassium Bicarbonate[1].
Q: What is the marketing category for Effer-K Orange?
A: Effer-K Orange falls under the category of "UNAPPROVED DRUG OTHER / UNAPPROVED DRUG OTHER"[1].
Q: How does the regulatory status affect the pricing of Effer-K Orange?
A: The unapproved status can make pricing more volatile and less predictable compared to FDA-approved drugs.
Q: What are the key factors influencing price projections for Effer-K Orange?
A: Key factors include utilization and demand, regulatory environment, competition, and economic factors such as inflation.
Q: What is the expected trend in pharmaceutical spending for 2024?
A: Overall prescription drug spending is expected to rise by 10.0% to 12.0% in 2024[3].
Sources
- FDA.report: NDC 51801-001 Oral Tablet, Effervescent Effer-K.
- DrugPatentWatch: Latest drug prices and trends for NDC 51672-1387.
- PubMed: National trends in prescription drug expenditures and projections for 2024.
- FDA: National Drug Code Directory.
- DrugPatentWatch: Latest drug prices and trends for NDC 59630-0551.
