Overview of NDC 51862-0486
The National Drug Code (NDC) 51862-0486 corresponds to Trimethoprim, a medication manufactured by Mayne Pharma. This NDC is part of the broader pharmaceutical market, which is subject to various factors influencing pricing and market dynamics.
Understanding the NDC Structure
The NDC 51862-0486 is a 10-digit code divided into three segments:
- Labeler Code: 51862, assigned by the FDA to Mayne Pharma.
- Product Code: Identifies the specific strength, dosage form, and formulation of Trimethoprim.
- Package Code: Identifies the package size and type[1].
Market Context
Pharmaceutical Market Trends
The pharmaceutical market is experiencing significant changes, including the rise of gene therapies and increasing costs for advanced treatments. For instance, the approval of high-cost gene therapies highlights the need for sustainable financial models in healthcare[3].
Price Inflation Projections
For the period from January 1, 2025, to December 31, 2025, the overall drug price inflation rate is projected to be 0.00%, indicating a stable pricing environment for many pharmaceuticals. However, this does not necessarily mean that prices for specific drugs like Trimethoprim will remain unchanged, as they can be influenced by various market and regulatory factors[3].
Pricing and Cost Considerations
Wholesale Acquisition Cost (WAC)
The pricing strategy for drugs like Trimethoprim involves setting a Wholesale Acquisition Cost (WAC), which is the list price at which the drug is sold to wholesalers. This cost can be adjusted based on market conditions, competition, and regulatory requirements. For example, Dr. Reddy's Laboratories adjusted the WAC pricing for their generic version of Lenalidomide to recoup costs, cover distribution, provide rebates, and earn a reasonable return on investment[2].
Cost Components
The pricing of Trimethoprim would include several cost components:
- Manufacturing Costs: The costs associated with producing the drug.
- Marketing Costs: Although Mayne Pharma may not engage in direct-to-consumer marketing or paid advertising for Trimethoprim, any promotional materials or product sell sheets provided to healthcare professionals would be included.
- Distribution Costs: Costs related to getting the drug from the manufacturer to the end-user.
- Rebates and Discounts: Any rebates or discounts offered to partners in the supply chain[2].
Regulatory Impact
FDA Approval and Listing
Trimethoprim, like other drugs, must be listed in the FDA's National Drug Code Directory. This listing ensures that the drug has been approved for marketing based on a review of its safety and effectiveness. The NDA/ANDA number associated with the NDC indicates FDA approval[1].
Medicare Drug Price Negotiation Program
While the Medicare Drug Price Negotiation Program primarily affects Medicare-covered drugs, it can have broader implications for the pharmaceutical market. Negotiated prices for selected drugs could influence market pricing strategies, although Trimethoprim's specific pricing would depend on whether it is selected for negotiation and its therapeutic alternatives[5].
Price Projections
Given the stable overall drug price inflation rate projected for 2025, it is likely that the price of Trimethoprim will remain relatively stable. However, several factors could influence this:
- Generic Competition: The presence of generic versions of Trimethoprim could drive prices down.
- Market Demand: Changes in demand due to public health needs or prescribing patterns.
- Regulatory Changes: Any changes in regulatory requirements or negotiations under programs like the Medicare Drug Price Negotiation Program could impact pricing[3].
Key Takeaways
- NDC Structure: The NDC 51862-0486 is a unique identifier for Trimethoprim by Mayne Pharma, divided into labeler, product, and package codes.
- Market Trends: The pharmaceutical market is experiencing stability in price inflation, but specific drug prices can vary based on competition, regulatory changes, and market demand.
- Pricing Components: The pricing of Trimethoprim includes manufacturing, marketing, distribution costs, and rebates/discounts.
- Regulatory Impact: FDA approval and listing, as well as broader regulatory programs, can influence pricing strategies.
FAQs
What is the NDC 51862-0486?
The NDC 51862-0486 is the unique identifier for Trimethoprim, a medication manufactured by Mayne Pharma.
What factors influence the pricing of Trimethoprim?
Pricing is influenced by manufacturing costs, marketing costs, distribution costs, rebates, and discounts, as well as market demand and regulatory changes.
Is the price of Trimethoprim expected to change in 2025?
Given the projected 0.00% overall drug price inflation rate, the price of Trimethoprim is likely to remain stable, but it can be affected by specific market and regulatory factors.
How does the Medicare Drug Price Negotiation Program impact Trimethoprim?
The program primarily affects Medicare-covered drugs, but negotiated prices for therapeutic alternatives could indirectly influence the pricing of Trimethoprim.
What is the significance of the FDA's National Drug Code Directory?
The directory ensures that listed drugs, including Trimethoprim, have been approved for marketing based on a review of their safety and effectiveness.
Sources
- FDA: National Drug Code Database Background Information - FDA
- Minnesota Department of Health: New Prescription Drug Price Reporting
- Vizient Inc.: Pharmacy Market Outlook Summer 2024
- FindACode: Mayne Pharma - List of Drugs - NDC Labeler/Manufacturer
- CMS: Medicare Drug Price Negotiation Program - CMS
