Market Analysis and Price Projections for NDC 65162-521: Promethazine Hydrochloride
Introduction
Promethazine Hydrochloride, identified by the National Drug Code (NDC) 65162-521, is a prescription drug manufactured and distributed by Amneal Pharmaceuticals LLC. This oral tablet is classified under the phenothiazine drug class and is used for various therapeutic purposes, including as an antihistamine, antiemetic, and sedative.
Market Context
The pharmaceutical market, particularly for prescription drugs, is characterized by significant price fluctuations and regulatory changes.
Global Market Trends
The biopharma and biotech industries are experiencing rapid growth, driven by technological advancements, evolving regulatory frameworks, and a shift towards patient-centered care. The biopharma market is projected to grow at a compound annual growth rate (CAGR) of 7.56% between 2024 and 2029, while the biotech sector is expected to grow at a CAGR of 9.4% between 2021 and 2027[3].
Pricing Dynamics
Prescription drug prices in the U.S. are notably higher compared to other regions. From 2017 to 2022, the average price per unit in the U.S. increased by 14%, while prices in the OECD (excluding the U.S.) and the rest of the world decreased by 9% and 7%, respectively. By 2022, prices in the U.S. were 5.5 times those in the OECD (excluding the U.S.) and 7.7 times those in the rest of the world[4].
Price Increases and Trends
Recent Price Changes
From January 2022 to January 2023, more than 4,200 drug products experienced price increases, with 46% of these increases exceeding the rate of inflation. The average price increase during this period was 15.2%, translating to $590 per drug product. This trend is consistent with historical data showing that the largest number of price increases typically occur in January and July each year[2].
Multi-Source vs. Single-Source Drugs
Price increases for multi-source drugs, such as generics, tend to be higher in percentage terms but lower in absolute dollar amounts compared to single-source drugs. For instance, from January 2022 to January 2023, the average price increase for multi-source drugs was 26.0% ($69), while single-source drugs saw an average increase of 7.4% ($958)[2].
Regulatory Environment
The regulatory landscape plays a crucial role in drug pricing and market dynamics.
FDA Approvals and Compliance
Drugs must have approved New Drug Applications (NDAs) to be eligible for inclusion in programs like the Medicaid Drug Rebate Program. Products without approved applications, such as some colchicine and propoxyphene products, are subject to enforcement action and cannot be marketed without appropriate FDA approval[5].
Impact on Pricing
Regulatory changes and enforcement actions can significantly impact drug prices. For example, drugs facing voluntary withdrawal notices due to safety concerns, like Darvon/Darvocet (Propoxyphene), can see their prices affected as they are removed from rebate programs and market circulation[5].
Specific Analysis for NDC 65162-521
Current Pricing
As of the last available data, Promethazine Hydrochloride tablets (NDC 65162-521) are marketed by Amneal Pharmaceuticals LLC with an active ingredient strength of 25 mg per tablet. The pricing for this drug would be influenced by the broader trends in the pharmaceutical market, including the general increase in prescription drug prices in the U.S.[1].
Projected Price Changes
Given the historical data and current trends, it is likely that the price of Promethazine Hydrochloride will continue to rise, albeit at a rate that may vary depending on several factors:
- Inflation and Market Dynamics: With an average price increase of 15.2% observed from January 2022 to January 2023, it is plausible that similar increases could occur in the future, especially if the drug is classified as a multi-source product[2].
- Regulatory Compliance: Ensuring ongoing compliance with FDA regulations will be crucial for maintaining market presence and pricing stability.
- Market Competition: The presence of other antihistamines and sedatives in the market could influence pricing strategies, potentially leading to more competitive pricing or further increases depending on market demand and supply.
Key Takeaways
- Pricing Trends: Prescription drug prices in the U.S. are generally increasing, with significant variations between multi-source and single-source drugs.
- Regulatory Impact: FDA approvals and compliance are critical for drug pricing and market participation.
- Market Growth: The biopharma and biotech sectors are experiencing rapid growth, driven by technological and regulatory advancements.
- Specific Drug Pricing: Promethazine Hydrochloride (NDC 65162-521) is likely to see price increases in line with broader market trends, influenced by inflation, regulatory compliance, and market competition.
FAQs
Q: What is the current active ingredient strength of Promethazine Hydrochloride tablets (NDC 65162-521)?
A: The current active ingredient strength is 25 mg per tablet[1].
Q: How have prescription drug prices in the U.S. changed from 2017 to 2022?
A: Prescription drug prices in the U.S. increased by an average of 14% from 2017 to 2022, significantly higher than in other regions[4].
Q: What is the typical timing for the largest number of prescription drug price increases?
A: The largest number of price increases typically occurs in January and the second largest in July each year[2].
Q: How do regulatory actions impact drug pricing?
A: Regulatory actions, such as FDA approvals and enforcement actions, can significantly affect drug prices by determining market eligibility and compliance[5].
Q: What are the projected growth rates for the biopharma and biotech industries?
A: The biopharma market is projected to grow at a CAGR of 7.56% between 2024 and 2029, while the biotech sector is expected to grow at a CAGR of 9.4% between 2021 and 2027[3].
Sources
- FDA Report: NDC 65162-521 Oral Tablet Promethazine Hydrochloride Drug.
- ASPE Issue Brief: Changes in the List Prices of Prescription Drugs, 2017-2023.
- TFS CRO: 5 Predictions for the Biopharma and Biotech Industries in 2025.
- ASPE Issue Brief: International Market Size and Prices.
- Medicaid: For State Technical Contacts - Medicaid.
