Market Analysis and Price Projections for the Drug NDC: 46122-0643
Understanding the National Drug Code (NDC)
To analyze the market and price projections for a specific drug, it is crucial to understand the National Drug Code (NDC) system. The NDC is a unique, 10-digit, three-segment number that identifies the labeler, product, and trade package size of a drug product[5].
NDC 46122-0643: Identification and Labeler
The NDC 46122-0643 can be broken down into three segments:
- Labeler Code: The first segment (46122) identifies the labeler, which could be a manufacturer, repackager, or relabeler.
- Product Code: The second segment identifies the specific strength, dosage form, and formulation of the drug.
- Package Code: The third segment identifies the package size and type.
Market Context and Trends
Overall Market Growth
The prescription drug market is expected to grow at a Compound Annual Growth Rate (CAGR) of 9% through 2030. This growth is driven by increasing demand, innovative therapies, and expanding healthcare access[4].
Pricing and Access Challenges
Pricing and access to drugs remain significant issues in the life sciences industry. Nearly half of C-suite executives surveyed expect pricing and access to significantly impact their strategies in 2025. This includes concerns over price increases, competition from generics and biosimilars, and the looming patent cliff[3].
Price Projections and Trends
Historical Price Data
To project future prices, it is essential to analyze historical price data. While specific data for NDC 46122-0643 is not provided, general trends can be inferred from similar drugs. For example, the drug Linezolid (NDC 00054-0319) has shown price fluctuations over recent months, with prices ranging from $1.69 to $2.58 per unit[4].
Negotiated Prices and Discounts
The Medicare Drug Price Negotiation Program, set to begin in 2026, will significantly impact drug prices. Negotiated prices for selected drugs have resulted in discounts ranging from 38% to 79% compared to list prices. This trend suggests that future price negotiations could lead to lower prices for many drugs, including those with similar NDCs[2].
Factors Influencing Price Projections
Regulatory Environment
The FDA's regulatory environment plays a crucial role in drug pricing. The inclusion of compounded drug products in the NDC Directory, for instance, is subject to specific reporting requirements and marketing categories. This can affect the availability and pricing of these drugs[1].
Competition and Patent Expirations
The life sciences industry is facing a substantial loss of exclusivity due to expiring patents on high-revenue products. This is expected to drive competition from generics and biosimilars, which can lead to lower prices. By 2030, over $300 billion in sales is at risk due to patent expirations[3].
Technological and Innovative Advances
Advances in genomics, biomarkers, and digital technologies are expected to improve operational efficiencies and drive innovation. Personalized medicine, for example, can offer more precise treatment options, potentially reducing costs and improving patient outcomes[3].
Market Analysis for NDC 46122-0643
Demand and Supply Dynamics
The demand for the drug identified by NDC 46122-0643 will be influenced by its therapeutic use, patient population, and competition within its market segment. Supply chain dynamics, including manufacturing capacities and distribution networks, will also impact pricing.
Competitive Landscape
The competitive landscape includes other drugs within the same therapeutic class, as well as potential generic or biosimilar alternatives. The entry of these alternatives can significantly reduce prices as seen in other markets.
Price Projection Scenarios
Scenario 1: Stable Market Conditions
If the market conditions remain stable, with no significant changes in demand or supply, prices for NDC 46122-0643 might follow the general trend of the prescription drug market, growing at a CAGR of around 9% through 2030.
Scenario 2: Increased Competition
If generic or biosimilar versions of the drug enter the market, prices could drop significantly. This scenario is likely if the drug's patent expires or if regulatory changes facilitate the entry of competitors.
Scenario 3: Regulatory Changes
If regulatory changes, such as those related to the Medicare Drug Price Negotiation Program, affect the pricing of drugs, NDC 46122-0643 could see substantial price reductions. Negotiated prices could result in discounts similar to those seen in the initial negotiation rounds.
Key Takeaways
- Market Growth: The prescription drug market is expected to grow at a CAGR of 9% through 2030.
- Pricing Challenges: Pricing and access remain significant issues, with potential impacts from competition and regulatory changes.
- Regulatory Influence: FDA regulations and programs like the Medicare Drug Price Negotiation Program can significantly affect drug prices.
- Technological Advances: Innovations in genomics and digital technologies can improve treatment options and reduce costs.
- Competition: The entry of generics and biosimilars can lead to lower prices.
FAQs
Q1: What is the National Drug Code (NDC) and how is it structured?
The NDC is a unique, 10-digit, three-segment number that identifies the labeler, product, and trade package size of a drug product[5].
Q2: How does the Medicare Drug Price Negotiation Program affect drug prices?
The program negotiates prices for selected drugs, resulting in discounts ranging from 38% to 79% compared to list prices, making drugs more affordable for Medicare enrollees[2].
Q3: What impact do patent expirations have on drug prices?
Patent expirations lead to the entry of generic and biosimilar drugs, which can significantly reduce prices due to increased competition[3].
Q4: How do technological advances influence drug pricing?
Technological advances, such as those in genomics and biomarkers, can improve treatment options and reduce costs by offering more precise and effective treatments[3].
Q5: What are the key factors influencing price projections for NDC 46122-0643?
Key factors include market demand and supply dynamics, competitive landscape, regulatory changes, and technological advances.
Sources
- FDA's National Drug Code Directory - FDA
- Medicare Drug Price Negotiation Program - ASPE, HHS.gov
- 2025 Life Sciences Executive Outlook - Deloitte Insights
- Latest drug prices and trends for NDC 00054-0319 - DrugPatentWatch
- National Drug Code Database Background Information - FDA