Market Analysis and Price Projections for NDC 76204-600: Ipratropium Bromide and Albuterol Sulfate
Introduction
Ipratropium Bromide and Albuterol Sulfate, identified by the National Drug Code (NDC) 76204-600, is a respiratory (inhalation) solution used to treat chronic obstructive pulmonary disease (COPD) and other respiratory conditions. This article provides a comprehensive market analysis and price projections for this drug, considering recent trends, regulatory changes, and industry outlook.
Market Context
The pharmaceutical industry, particularly the segment dealing with generic and combination drugs like Ipratropium Bromide and Albuterol Sulfate, is subject to various market forces. The generic drug industry is characterized by mid-single-digit percent annual price erosion, which can impact revenue growth[3].
Regulatory Environment
The Inflation Reduction Act (IRA) has introduced significant changes in the way drug prices are negotiated, especially for Medicare Part D. Beginning in January 2026, negotiated prices for selected drugs, including some respiratory medications, will come into effect. These negotiations aim to reduce the list prices of drugs, which have seen substantial increases over the years. For instance, nine out of the ten drugs selected for the first year of negotiation had list price increases ranging from 20% to 55% between 2018 and 2023[2].
Pricing Trends
Historically, the prices of prescription drugs, including those like Ipratropium Bromide and Albuterol Sulfate, have been on the rise. However, with the implementation of the IRA, there is a likelihood of significant discounts. Negotiated prices under the IRA have resulted in discounts ranging from 38% to 79% compared to list prices[2].
Generic Drug Market Dynamics
The generic drug market, where Ipratropium Bromide and Albuterol Sulfate resides, is expected to see modest revenue growth despite mid-single-digit percent annual price erosion. This erosion is a common trend in the commodity-like generic drug industry[3].
Manufacturer and Labeler
Ipratropium Bromide and Albuterol Sulfate is labeled and distributed by Ritedose Pharmaceuticals, LLC. The marketing start date for this product was October 15, 2012, indicating it has been in commercial distribution for over a decade[1].
Active Ingredients and Pharmacological Classes
The drug contains Albuterol Sulfate and Ipratropium Bromide as active ingredients. Albuterol Sulfate acts as an adrenergic beta2-agonist, while Ipratropium Bromide functions as an anticholinergic and cholinergic antagonist. These pharmacological classes are crucial for understanding the drug's efficacy and market positioning[1].
National Drug Code Directory
The FDA's National Drug Code Directory provides detailed information about finished drug products, including Ipratropium Bromide and Albuterol Sulfate. The NDC directory is updated daily and includes product listing data submitted by labelers, ensuring that all commercially distributed drugs are accounted for[5].
Price Projections
Given the current regulatory environment and market trends:
Impact of IRA Negotiations
Starting in January 2026, if Ipratropium Bromide and Albuterol Sulfate were to be selected for negotiation under the IRA, the drug could see significant price reductions. Historical data suggests that negotiated prices could result in discounts of up to 79% compared to list prices[2].
Generic Price Erosion
The generic drug industry is expected to experience mid-single-digit percent annual price erosion. This trend is likely to continue, affecting the pricing of Ipratropium Bromide and Albuterol Sulfate[3].
Revenue Growth
Despite price erosion, the generic drug industry is anticipated to see modest revenue growth. This growth could be driven by increased demand for respiratory medications and the expanding patient population[3].
Industry Risks and Opportunities
Price-Fixing Litigation
The generic drug industry faces risks such as price-fixing litigation, which could impact pricing strategies and revenue projections[3].
FDA Inspections
Increased FDA inspections of foreign manufacturing facilities could also pose challenges, potentially affecting supply chains and pricing stability[3].
Biosimilar Competition
While not directly related to Ipratropium Bromide and Albuterol Sulfate, the rise of biosimilars in other therapeutic areas could influence overall industry dynamics and pricing strategies[3].
Conclusion
The market analysis for Ipratropium Bromide and Albuterol Sulfate indicates a complex interplay of regulatory changes, market trends, and industry dynamics. Here are the key takeaways:
- Regulatory Impact: The IRA's price negotiation program could significantly reduce the list prices of selected drugs, including potentially Ipratropium Bromide and Albuterol Sulfate.
- Price Erosion: The generic drug industry is expected to experience mid-single-digit percent annual price erosion.
- Revenue Growth: Despite price erosion, modest revenue growth is anticipated due to increased demand.
- Industry Risks: Price-fixing litigation and increased FDA inspections are potential risks.
Key Takeaways
- Regulatory changes under the IRA could lead to significant price reductions.
- Generic price erosion is a persistent trend.
- Modest revenue growth is expected despite price erosion.
- Industry risks include price-fixing litigation and increased FDA inspections.
FAQs
What is the NDC for Ipratropium Bromide and Albuterol Sulfate?
The NDC for Ipratropium Bromide and Albuterol Sulfate is 76204-600[1].
What are the active ingredients in Ipratropium Bromide and Albuterol Sulfate?
The active ingredients are Albuterol Sulfate and Ipratropium Bromide[1].
How might the IRA affect the pricing of Ipratropium Bromide and Albuterol Sulfate?
The IRA's price negotiation program could result in significant discounts, potentially up to 79% compared to list prices, if the drug is selected for negotiation[2].
What are the pharmacological classes of the active ingredients?
Albuterol Sulfate is an adrenergic beta2-agonist, and Ipratropium Bromide is an anticholinergic and cholinergic antagonist[1].
What are the potential risks for the generic drug industry in 2024?
Potential risks include price-fixing litigation and increased FDA inspections of foreign manufacturing facilities[3].
Sources
- FDA Report: NDC 76204-600 Respiratory (inhalation) Solution IPRATROPIUM BROMIDE AND ALBUTEROL SULFATE.
- ASPE - HHS.gov: Medicare Drug Price Negotiation Program.
- S&P Global: Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures.
- CRS Reports: Medicare Drug Price Negotiation Under the Inflation Reduction Act.
- FDA: National Drug Code Directory.
