Introduction to Acetazolamide
Acetazolamide, identified by the National Drug Code (NDC) 51672-4022, is a medication used to treat various conditions, including glaucoma, epilepsy, and altitude sickness. It is an inhibitor of the enzyme carbonic anhydrase and is available in tablet form, packaged by Taro Pharmaceuticals U.S.A., Inc.[5].
Understanding the National Drug Code (NDC)
The NDC 51672-4022 is a unique identifier that breaks down into three segments: the labeler code, product code, and package code. The labeler code (51672) is assigned by the FDA and identifies Taro Pharmaceuticals U.S.A., Inc. as the manufacturer or distributor. The product code identifies the specific strength, dosage form, and formulation of the drug, while the package code specifies the package size and type[1].
Current Market Trends in the Pharmaceutical Industry
The pharmaceutical industry is experiencing several key trends that could impact the pricing and market dynamics of drugs like acetazolamide.
Generic Drug Market
The generic drug market, which includes drugs like acetazolamide, is expected to see mid-single-digit percent annual price erosion. However, there is also a forecast of modest revenue growth, which is an improvement from recent years[3].
Specialty Pharmaceuticals
While acetazolamide is not classified as a specialty pharmaceutical, the overall trend in the pharmaceutical market is driven by these high-cost, complex, or chronic condition treatments. Specialty pharmaceuticals are projected to drive a 3.8% increase in drug prices, with a particular focus on weight loss drugs and gene therapies[4].
Biosimilars
Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are expected to grow in market share. However, since acetazolamide is a small molecule drug and not a biologic, the impact of biosimilars on its pricing will be minimal[4].
Price Projections for Acetazolamide
Given the current market trends, here are some key points to consider for price projections of acetazolamide:
Generic Drug Price Erosion
Acetazolamide, being a generic drug, is likely to experience price erosion. The median price increase for generic drugs has been lower than that for brand name drugs, and there is an expectation of mid-single-digit percent annual price erosion[3].
Historical Price Increases
While specific historical data for acetazolamide is not provided, the generic drug market has seen significant price increases in some cases. For example, a generic version of naproxen saw a 2,527% price increase from 2012 to 2021. However, such extreme cases are not typical and are often subject to regulatory scrutiny[2].
Market Competition
The generic drug market is highly competitive, which generally keeps prices in check. However, the quality of information submitted by manufacturers can vary, making it challenging to determine the exact reasons for price changes[2].
Regulatory and Litigation Risks
FDA Inspections
The pharmaceutical industry, including generic drug manufacturers, faces potential risks from increased FDA inspections of foreign manufacturing facilities. This could impact the supply chain and pricing if manufacturers face compliance issues or production disruptions[3].
Price-Fixing Litigation
Price-fixing litigation is another risk for the generic drug industry. Any involvement in such litigation could lead to significant financial penalties and reputational damage, potentially affecting the pricing and availability of drugs like acetazolamide[3].
Conclusion
The pricing of acetazolamide (NDC: 51672-4022) is influenced by several factors, including the overall trends in the generic drug market, regulatory risks, and market competition.
- Price Erosion: Expect mid-single-digit percent annual price erosion due to market competition and regulatory pressures.
- Regulatory Risks: Increased FDA inspections and potential price-fixing litigation could impact the supply chain and pricing.
- Market Trends: The growth in specialty pharmaceuticals and biosimilars, while not directly affecting acetazolamide, indicates a dynamic market with various cost pressures.
Key Takeaways
- Acetazolamide is a generic drug subject to price erosion due to market competition.
- Regulatory risks, including FDA inspections and price-fixing litigation, can impact pricing and availability.
- The overall pharmaceutical market is driven by trends in specialty and biosimilar drugs, which may indirectly influence generic drug pricing.
FAQs
Q: What is the National Drug Code (NDC) and how is it structured?
A: The NDC is a 10-digit number that identifies a drug product. It is divided into three segments: the labeler code, product code, and package code[1].
Q: What are the current trends in the generic drug market?
A: The generic drug market is expected to see mid-single-digit percent annual price erosion and modest revenue growth[3].
Q: How do regulatory risks impact the pricing of generic drugs?
A: Increased FDA inspections and price-fixing litigation can lead to compliance issues, production disruptions, and financial penalties, all of which can affect pricing[3].
Q: What is the role of biosimilars in the pharmaceutical market?
A: Biosimilars are expected to grow in market share, particularly for biologic drugs, but they do not directly impact the pricing of small molecule generic drugs like acetazolamide[4].
Q: How does market competition influence the pricing of generic drugs?
A: Market competition generally keeps prices in check, but the quality of information submitted by manufacturers can vary, making it challenging to determine exact price trends[2].
Sources
- FDA: National Drug Code Database Background Information.
- Oregon Drug Price Transparency Program: Prescription Drug Price Transparency Results and Recommendations.
- S&P Global: Pharmaceutical Industry 2024 Credit Outlook Is Stable As Revenue Growth Mitigates Pressures.
- Vizient, Inc.: Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals.
- DailyMed: Label: ACETAZOLAMIDE tablet.
