Overview of the Drug
The drug with the National Drug Code (NDC) 51991-0333 is Carbinoxamine Maleate, manufactured by Breckenridge Pharmaceutical, Inc. This medication is commonly used to treat allergic reactions and is part of the antihistamine class of drugs.
Current Market Context
Pharmaceutical Industry Outlook
The pharmaceutical industry, particularly the generic drug sector, is expected to experience mid-single-digit percent annual price erosion in 2024. However, there is a forecast of modest revenue growth, which is an improvement from recent trends[3].
Specialty Pharmaceuticals
While the focus here is on a generic drug, it's important to note that the overall pharmaceutical market is heavily influenced by specialty pharmaceuticals. These drugs, which treat complex or chronic conditions, are driving a significant portion of the market growth. For instance, Vizient projects a 3.8% drug price increase in 2024, largely driven by specialty pharmaceuticals[4].
Price Projections
Generic Drug Price Erosion
Given that Carbinoxamine Maleate is a generic drug, it is likely to be affected by the general trend of price erosion in the generic drug market. This means that the price of Carbinoxamine Maleate could decrease by mid-single-digit percentages annually[3].
Market Competition
The presence of multiple manufacturers and the competitive nature of the generic drug market can further drive down prices. Breckenridge Pharmaceutical, Inc., like other generic drug manufacturers, will need to navigate this competitive landscape to maintain market share.
Specific Price Data
As of the latest available data, the price of Carbinoxamine Maleate (NDC 51991-0333) is not explicitly listed in the sources provided. However, prices for generic drugs are generally influenced by market forces such as supply and demand, regulatory changes, and competition.
Regulatory Environment
Outsourcing facilities, including those that may produce compounded versions of drugs like Carbinoxamine Maleate, are regulated under Section 503B of the FD&C Act. These facilities must report their compounded drugs to the FDA, which can impact the overall supply and pricing of these medications[1].
Biosimilars and Generic Market Dynamics
While Carbinoxamine Maleate is not a biosimilar, the growth of biosimilars in the market can indirectly affect generic drug prices. Biosimilars are expected to increase in market share, which could lead to more competitive pricing across the board. However, this impact is more significant for biologic drugs rather than generic antihistamines like Carbinoxamine Maleate[4].
Supply Chain and Drug Shortages
The pharmaceutical industry has faced challenges such as drug shortages and supply chain disruptions. Managing these issues is crucial for maintaining stable prices and ensuring continuous supply. Any disruptions in the supply chain could potentially affect the pricing of Carbinoxamine Maleate[4].
Conclusion
Given the current market trends and regulatory environment:
- Price Erosion: Carbinoxamine Maleate (NDC 51991-0333) is likely to experience mid-single-digit percent annual price erosion due to the competitive nature of the generic drug market.
- Market Competition: The presence of multiple manufacturers and the increasing competition from biosimilars in other segments of the market will continue to influence pricing.
- Regulatory Compliance: Compliance with FDA regulations, especially for outsourcing facilities, will be crucial in maintaining the supply and pricing stability of the drug.
Key Takeaways
- Generic drugs like Carbinoxamine Maleate are expected to see price erosion.
- The overall pharmaceutical market is influenced by specialty pharmaceuticals and biosimilars.
- Regulatory compliance and supply chain management are critical for stable pricing.
- Market competition drives down prices in the generic drug sector.
FAQs
-
What is the NDC 51991-0333 for?
- The NDC 51991-0333 is for Carbinoxamine Maleate, an antihistamine used to treat allergic reactions.
-
What is the expected price trend for generic drugs in 2024?
- Generic drugs are expected to experience mid-single-digit percent annual price erosion in 2024[3].
-
How do biosimilars affect the generic drug market?
- Biosimilars can increase market competition, which may indirectly affect the pricing of generic drugs by driving down prices across the board[4].
-
What role do outsourcing facilities play in drug pricing?
- Outsourcing facilities, regulated under Section 503B of the FD&C Act, must report their compounded drugs to the FDA, which can impact supply and pricing[1].
-
What are the main drivers of the projected 3.8% drug price increase in 2024?
- The increase is driven by specialty pharmaceuticals, including weight loss drugs and the anticipated expansion of gene therapies[4].
Sources
- FDA's National Drug Code Directory - FDA
- MISSOURI SPECIALTY MAC NAME OF DRUG Strength NDC Price - Missouri Department of Social Services
- Pharmaceutical Industry 2024 Credit Outlook - S&P Global
- Vizient Projects 3.8% Drug Price Increase Driven by Specialty Pharmaceuticals - Vizient, Inc.
- Breckenridge Pharmaceutical, Inc. - List of Drugs - NDC Labeler - FindACode
