Last updated: January 6, 2025
Introduction
The National Drug Code (NDC) 16571-0754 corresponds to Neomycin and Polymyxin B Sulfates, a product manufactured by Rising Pharma Holdings, Inc. This analysis will delve into the market dynamics, pricing factors, and future projections for this specific drug.
Market Context
Industry Trends
The pharmaceutical industry is undergoing significant transformations driven by digital advancements, innovative therapies, and regulatory changes. The COVID-19 pandemic has accelerated the issuance of new NDC codes, exacerbating the need for a new format to avoid running out of 10-digit codes[2].
Competitive Landscape
The market for antibiotic ointments like Neomycin and Polymyxin B Sulfates is competitive, with multiple manufacturers and generic options available. Rising Pharma Holdings, Inc., the manufacturer of NDC 16571-0754, operates in a sector where pricing and access to drugs are critical issues. Nearly half of life sciences executives surveyed expect pricing and access to significantly impact their strategies in 2025[3].
Pricing Factors
Current Pricing
The pricing of Neomycin and Polymyxin B Sulfates is influenced by several factors, including production costs, market demand, and regulatory requirements. As a generic product, it is generally priced lower than brand-name alternatives.
Regulatory Impact
The proposed change to the NDC format from 10 digits to 12 digits could have indirect effects on pricing. The transition period and the need for system updates across the healthcare supply chain may lead to temporary increases in operational costs, which could be reflected in the pricing of drugs[2].
Market Demand
The demand for antibiotic ointments remains steady due to their widespread use in treating minor cuts and scrapes. However, the rise of generic and biosimilar drugs could impact pricing strategies as companies compete for market share[3].
Price Projections
Short-Term Projections
In the short term, the price of Neomycin and Polymyxin B Sulfates is likely to remain stable, influenced by the existing market dynamics and the availability of generic alternatives. However, the transition to the new 12-digit NDC format could introduce some volatility as companies adjust to the new system.
Long-Term Projections
In the long term, several factors will influence pricing:
- Regulatory Changes: The adoption of a uniform 12-digit NDC format is expected to streamline processes and reduce the need for multiple format conversions, potentially leading to cost savings that could be passed on to consumers[2].
- Competition from Generics and Biosimilars: The increasing competition from generic drugs and biosimilars may drive prices down as companies compete for market share[3].
- Innovation and R&D: Advances in drug delivery devices and alternative routes of administration could lead to new products that might affect the pricing of traditional antibiotic ointments[5].
Impact of NDC Format Change
The proposed change to the NDC format is a significant event that will impact nearly every system in the healthcare supply chain. Here are some key points:
Transition Period
The FDA is proposing a delayed effective date for the new 12-digit NDC format, allowing a transition period of five years. This period will be crucial for stakeholders to update their systems and ensure a smooth transition[2].
System Updates
The transition will require significant updates to IT systems, labeling, and barcode requirements. While this may introduce short-term costs, it is expected to bring long-term benefits in terms of efficiency and uniformity[2].
Key Takeaways
- Market Stability: The market for Neomycin and Polymyxin B Sulfates is expected to remain relatively stable in the short term.
- Regulatory Impact: The transition to a 12-digit NDC format could introduce short-term volatility but is expected to bring long-term efficiency and cost savings.
- Competition: Increasing competition from generics and biosimilars will continue to influence pricing strategies.
- Innovation: Advances in drug delivery and alternative routes of administration may impact the market for traditional antibiotic ointments.
FAQs
Q: What is the current NDC format, and why is it being changed?
A: The current NDC format is 10 digits, but it is being changed to a 12-digit format to address the issue of running out of unique codes and to standardize the format across the healthcare industry[2].
Q: How will the NDC format change affect the pricing of Neomycin and Polymyxin B Sulfates?
A: The immediate impact on pricing is expected to be minimal, but long-term cost savings from streamlined processes could lead to lower prices. However, this will depend on various market and regulatory factors[2].
Q: What is the expected timeline for the transition to the new NDC format?
A: The FDA is proposing a transition period of five years from the publication of the final rule to allow stakeholders to update their systems[2].
Q: How will the rise of generic and biosimilar drugs affect the market for Neomycin and Polymyxin B Sulfates?
A: The rise of generic and biosimilar drugs is likely to increase competition, which could drive prices down as companies compete for market share[3].
Q: What role will innovation in drug delivery devices play in the future of antibiotic ointments?
A: Innovations in drug delivery devices and alternative routes of administration could lead to new products that might affect the market for traditional antibiotic ointments, potentially offering patients more convenient and effective treatment options[5].
Sources
- Wolters Kluwer: Are You Prepared for a Major Industry Change to the National Drug Code (NDC) Number?
- FDA: Proposed Rule on Revising the National Drug Code Format
- Deloitte Insights: 2025 Life Sciences Executive Outlook
- Find-A-Code: Rising Pharma Holdings, Inc. - List of Drugs
- Drug Delivery Leader: 5 Reasons Why 2025 Is The Year Pharma Companies Will Revisit Their Drug Delivery Device Strategies