Introduction
Acetaminophen and Codeine Phosphate, with the NDC code 0406-0484, is a prescription drug that combines acetaminophen and codeine phosphate to treat pain. Here, we will delve into the market analysis and price projections for this medication.
Drug Overview
- Generic Name: Acetaminophen and Codeine Phosphate
- Dosage Form: Oral Tablet
- Route of Administration: Oral
- DEA Schedule: CIII, indicating it is a controlled substance[1][4].
Market Context
The pharmaceutical market, particularly for prescription drugs, is subject to various regulatory and economic factors. Recent initiatives, such as the Medicare Drug Price Negotiation Program, have significant implications for drug pricing.
Medicare Drug Price Negotiation Program
While the Medicare Drug Price Negotiation Program primarily targets high-expenditure, single-source drugs without generic or biosimilar competition, it sets a precedent for price negotiations in the pharmaceutical industry. For example, the program has negotiated prices for drugs like Eliquis, Jardiance, and Enbrel, resulting in substantial savings for Medicare beneficiaries. Although Acetaminophen and Codeine Phosphate is not currently part of this program, the broader impact on drug pricing strategies is noteworthy[2][3].
Current Pricing
- Active Ingredients: 300 mg of acetaminophen and codeine phosphate per tablet.
- Labeler: SpecGx LLC.
- Marketing Start Date: 2001-05-31[1].
The current pricing of Acetaminophen and Codeine Phosphate is influenced by market demand, production costs, and regulatory environments. However, specific price data for this drug is not publicly available in the same detail as for the drugs selected under the Medicare negotiation program.
Price Trends in the Pharmaceutical Industry
The pharmaceutical industry has seen significant price increases over the years. For instance, the list prices of many drugs have risen by 20% to 55% between 2018 and 2023. This trend is a result of various factors, including research and development costs, market demand, and the absence of generic or biosimilar competition[2].
Projected Price Changes
Given the current regulatory and market environment, here are some potential price projections:
Regulatory Impact
While Acetaminophen and Codeine Phosphate is not currently subject to the Medicare Drug Price Negotiation Program, future regulatory changes could impact its pricing. If similar negotiation programs expand to include more drugs, we might see price reductions.
Market Dynamics
The demand for pain management medications remains high, which could support stable or slightly increasing prices. However, increased competition from generic or alternative pain management options could lead to price stability or slight decreases.
Economic Factors
Economic conditions, such as inflation and changes in healthcare policies, can also influence drug prices. For example, the Consumer Price Index (CPI-U) adjustments could affect negotiated prices for drugs under the Medicare program, although this would not directly impact Acetaminophen and Codeine Phosphate unless it is included in future negotiations[5].
Potential Savings Mechanisms
- Generic Competition: If a generic version of Acetaminophen and Codeine Phosphate becomes available, it could significantly reduce prices.
- Alternative Treatments: The development of alternative pain management treatments could also drive prices down due to increased competition.
- Regulatory Interventions: Future expansions of drug price negotiation programs could include more medications, potentially leading to lower prices for a broader range of drugs.
Consumer Impact
For consumers, the pricing of Acetaminophen and Codeine Phosphate is crucial as it affects out-of-pocket costs. Any significant price changes, whether due to regulatory actions or market dynamics, would directly impact patient affordability.
Industry Expert Insights
Industry experts often highlight the complex interplay between regulatory policies, market competition, and economic factors in determining drug prices. For example:
"The pharmaceutical industry is highly regulated, and pricing is influenced by a multitude of factors including research and development costs, market demand, and regulatory environments."[3]
Illustrative Statistics
- The Medicare Drug Price Negotiation Program has resulted in negotiated prices that are 38% to 79% lower than the list prices for the selected drugs[2].
- For drugs like Januvia, the negotiated price reduction is as high as 79%[3].
While these statistics are specific to the negotiated drugs, they illustrate the potential impact of regulatory interventions on drug pricing.
Key Takeaways
- Regulatory Environment: Current and future regulatory changes, such as the Medicare Drug Price Negotiation Program, can significantly impact drug prices.
- Market Dynamics: Demand for pain management medications and competition from generic or alternative treatments influence pricing.
- Economic Factors: Inflation and healthcare policy changes can affect drug prices.
- Potential Savings: Generic competition, alternative treatments, and regulatory interventions could lead to lower prices.
FAQs
Q: What is the current DEA schedule for Acetaminophen and Codeine Phosphate?
A: Acetaminophen and Codeine Phosphate is classified as a Schedule III controlled substance[1][4].
Q: How does the Medicare Drug Price Negotiation Program affect drug prices?
A: The program negotiates lower prices for selected high-expenditure drugs, resulting in significant savings for Medicare beneficiaries[2][3].
Q: What are the potential factors that could influence the price of Acetaminophen and Codeine Phosphate?
A: Regulatory changes, market competition, economic conditions, and the availability of generic or alternative treatments could influence the price[1][2][5].
Q: Are there any projected price changes for Acetaminophen and Codeine Phosphate?
A: While there are no specific projections available, the drug could be affected by broader market and regulatory trends[1][2].
Q: How do economic factors like inflation impact drug prices?
A: Economic factors such as inflation can lead to price adjustments, as seen in the CPI-U adjustments for negotiated prices under the Medicare program[5].
Cited Sources
- FDA Report: NDC 0406-0484 Oral Tablet ACETAMINOPHEN AND CODEINE PHOSPHATE.
- ASPE - HHS.gov: Medicare Drug Price Negotiation Program - ASPE - HHS.gov.
- White House Briefing Room: Fact Sheet: Biden-Harris Administration Announces New, Lower Prices for First Ten Drugs Selected for Medicare Price Negotiation.
- DailyMed: ACETAMINOPHEN AND CODEINE PHOSPHATE tablet.
- CMS: Negotiated Prices for Initial Price Applicability Year 2026 - CMS.
