Understanding the National Drug Code (NDC)
To analyze the market and price projections for a drug identified by the NDC 16714-157, it is crucial to first understand what the NDC represents. The National Drug Code (NDC) is a unique, three-segment number that serves as a universal product identifier for human drugs in the United States. This code identifies the labeler, product, and trade package size of the drug[5].
Drug Identification
The NDC 16714-157 corresponds to a Progesterone capsule, which is a human prescription drug. Here are the key details:
- Labeler: Northstar Rx LLC
- Product: Progesterone capsule
- Marketing Status: Abbreviated New Drug Application (ANDA)[4].
Market Context
Prescription Drug Market
The prescription drug market is influenced by various factors, including regulatory requirements, competition, and pricing strategies. For drugs like Progesterone, which are widely used in women's health, market dynamics can be complex.
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Regulatory Oversight: The FDA requires drug establishments to list their products in the National Drug Code Directory. This ensures that all drugs, including those with NDCs like 16714-157, are tracked and regulated[1][5].
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Competition: The market for hormonal therapies, including progesterone, is competitive. Generic versions of these drugs often enter the market after the patent expiration of the original branded products, which can significantly impact pricing and market share[3].
Pricing Transparency
Pricing transparency is a critical aspect of the pharmaceutical market. For drugs like Progesterone, price changes can be influenced by several factors:
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Price Increases: Manufacturers are required to report price increases and new high-cost drugs to regulatory bodies. For instance, in Oregon, manufacturers must report to the Department of Consumer and Business Services (DCBS) when price increases occur or new high-cost drugs are introduced[2].
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Generic Competition: The entry of generic versions can lead to significant price reductions. For example, the median price increase for generic drugs was 19.9% in one report, but generic competition generally drives prices down over time[2].
Price Projections
Current Pricing
As of the latest available data, the pricing for Progesterone capsules, such as those identified by NDC 16714-157, would be influenced by the current market conditions, including the presence of generic competitors and the pricing strategies of the labeler.
Future Pricing Trends
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Generic Impact: If the patent for the branded version of Progesterone has expired or is nearing expiration, the entry of generic versions is likely to reduce prices. Generic drugs typically offer significant cost savings compared to their branded counterparts[3].
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Regulatory Influence: Regulatory measures aimed at increasing transparency and controlling price increases can also impact future pricing. For instance, state-level initiatives like Oregon's Prescription Drug Price Transparency Program aim to monitor and regulate price increases, which could stabilize or reduce prices over time[2].
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Market Competition: The level of competition in the market will also play a crucial role. If multiple generic versions of Progesterone are available, this could drive prices down further due to increased competition.
Statistical Insights
While specific price projections for NDC 16714-157 are not available, here are some general statistical insights that might influence its pricing:
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Generic Sales Growth: Sales of generic drugs are expected to grow as patents expire for branded drugs. For example, in the NSCLC market, sales of generic pemetrexed are projected to reach $266 million by 2025, indicating a significant shift towards generics[3].
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Price Increases: Median price increases for generic drugs have been reported at 19.9%, but extreme cases like a 2,527% increase for a generic naproxen highlight the variability in pricing trends[2].
Expert Opinions
Industry experts often emphasize the importance of regulatory compliance and market competition in shaping drug prices.
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Regulatory Compliance: "The accuracy of the listing data is the responsibility of the company submitting the information to FDA. The agency monitors data accuracy and integrity through its compliance program," which underscores the role of regulatory oversight in maintaining fair market practices[1].
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Market Dynamics: "The price of a prescription drug is influenced by numerous factors, including the interactions and financial negotiations between pharmaceutical supply chain entities," highlighting the complex interplay of factors affecting drug prices[2].
Key Takeaways
- NDC Identification: The NDC 16714-157 identifies a Progesterone capsule, a human prescription drug.
- Market Context: The prescription drug market is regulated by the FDA, and pricing is influenced by competition, generic entries, and regulatory measures.
- Pricing Trends: Future pricing for Progesterone capsules will likely be affected by the entry of generic versions, regulatory oversight, and market competition.
- Statistical Insights: Generic drug sales are expected to grow, and price increases can be significant but variable.
FAQs
1. What does the NDC 16714-157 represent?
The NDC 16714-157 represents a Progesterone capsule, which is a human prescription drug.
2. How does the FDA regulate drug pricing?
The FDA does not directly regulate drug pricing but ensures that drug establishments comply with listing and reporting requirements, which helps in monitoring price changes and market dynamics[1][5].
3. What impact do generic drugs have on pricing?
Generic drugs typically reduce prices significantly as they enter the market, increasing competition and driving down the cost of the drug[3].
4. How do state-level initiatives affect drug pricing?
State-level initiatives, such as Oregon's Prescription Drug Price Transparency Program, aim to increase transparency and regulate price increases, which can help stabilize or reduce prices over time[2].
5. What are the key factors influencing the price of prescription drugs?
The price of prescription drugs is influenced by interactions and financial negotiations between pharmaceutical supply chain entities, including manufacturers, pharmacy benefit managers (PBMs), and regulatory bodies[2].
Sources
- FDA's National Drug Code Directory - FDA
- Prescription Drug Price Transparency Results and Recommendations - Oregon Department of Consumer and Business Services
- NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025 - GlobalData
- PROGESTERONE capsule - DailyMed
- National Drug Code Database Background Information - FDA
