Market Analysis and Price Projections for the Drug NDC: 45802-0122
Understanding the NDC Code
The National Drug Code (NDC) is a unique, three-segment number that identifies a drug product. For the NDC code 45802-0122, each segment provides specific information:
- The first segment, the labeler code (45802), is assigned by the FDA and identifies the firm that manufactures, repacks, or relabels the drug.
- The second segment, the product code (0122), identifies the specific strength, dosage form, and formulation of the drug.
- The third segment, the package code (no specific package code provided here), identifies the package size and type[1].
Market Context of Prescription Drugs
Global and U.S. Market Trends
The U.S. pharmaceutical market is characterized by high prices and significant revenue. In 2022, the U.S. accounted for about 50% of worldwide sales revenues for prescription drugs but only 13% of the total volume. This disparity is due to the higher average prices per unit in the U.S. compared to other countries. For instance, prices in the U.S. were 5.5 times those in the OECD (excluding the U.S.) and 7.7 times those in the rest of the world[3].
Price Inflation Projections
According to Vizient's summer 2024 Pharmacy Market Outlook, the overall drug price inflation rate for pharmaceuticals in 2025 is projected to be 3.81%. This projection is influenced by factors such as the expanding indications of previously approved medications and the introduction of high-cost cell and gene therapies[2].
Specific Drug Market Analysis
Drug Pricing Transparency
The Oregon Drug Price Transparency Program provides insights into the pricing dynamics of prescription drugs. The program has reported significant price increases, with the median price increase for generic drugs being 19.9% and for brand name drugs being 13.4% in 2022. Such transparency programs help in understanding the factors influencing drug prices, including interactions between pharmaceutical supply chain entities, rebates, and other financial negotiations[5].
Impact of Regulatory Oversight
Regulatory oversight and transparency measures can significantly impact drug pricing. For example, the Prescription Drug Price Transparency Act in Oregon requires manufacturers to report price increases and new high-cost drugs. This oversight helps in monitoring costs and identifying gaps in transparency, such as the influence of coupons, discounts, and rebates on the final cost to consumers[5].
Price Projections for NDC: 45802-0122
Given the general trends in the pharmaceutical market:
Average Price Increases
Based on the median price increases reported by the Oregon Drug Price Transparency Program, it is reasonable to expect that the drug with NDC 45802-0122 could experience a price increase in the range of 13.4% to 19.9% if it follows the trends for brand name and generic drugs, respectively[5].
Overall Market Inflation
Considering Vizient's projection of a 3.81% overall drug price inflation rate for 2025, this could also contribute to the price increase of the drug with NDC 45802-0122. However, this rate is an average and actual increases can vary widely depending on the specific drug and market conditions[2].
Example of Similar Drugs
For drugs like testosterone gel, which might have similar market dynamics, price changes can be significant. For instance, if a drug experiences a price increase similar to other prescription drugs, it could see a substantial rise in its wholesale acquisition cost (WAC)[4].
Key Factors Influencing Price
Supply Chain Dynamics
The price of a prescription drug is influenced by various factors within the pharmaceutical supply chain, including financial negotiations between manufacturers, pharmacy benefit managers (PBMs), and health insurers. Transparency in these interactions is crucial for understanding and managing price increases[5].
Regulatory Environment
State and federal regulations, such as the Prescription Drug Price Transparency Act and the Inflation Reduction Act of 2022, can impact drug prices. These regulations may lead to upper payment limits or price negotiations, which could affect the pricing of specific drugs[5].
Conclusion
The price of the drug with NDC 45802-0122 is likely to be influenced by the broader trends in the pharmaceutical market, including average price increases and overall market inflation. Here are some key points to consider:
- Price Inflation: Expect a price increase in the range of 13.4% to 19.9% based on median increases for brand name and generic drugs.
- Market Trends: The overall drug price inflation rate of 3.81% for 2025 could also impact the price.
- Regulatory Environment: Transparency and regulatory measures can influence pricing dynamics.
- Supply Chain: Interactions between supply chain entities play a significant role in determining final drug prices.
Key Takeaways
- The U.S. pharmaceutical market is characterized by high prices and significant revenue.
- Average price increases for prescription drugs range from 13.4% to 19.9%.
- Overall market inflation is projected at 3.81% for 2025.
- Regulatory oversight and transparency are crucial for managing drug prices.
- Supply chain dynamics significantly influence final drug prices.
FAQs
Q: What is the National Drug Code (NDC) and how is it structured?
A: The NDC is a unique, three-segment number that identifies a drug product. It includes a labeler code, product code, and package code.
Q: What are the main factors influencing prescription drug prices in the U.S.?
A: Factors include interactions between pharmaceutical supply chain entities, regulatory oversight, and overall market inflation.
Q: How does the Oregon Drug Price Transparency Program impact drug pricing?
A: The program requires manufacturers to report price increases and new high-cost drugs, helping to monitor costs and identify gaps in transparency.
Q: What is the projected overall drug price inflation rate for 2025 according to Vizient?
A: The projected overall drug price inflation rate for 2025 is 3.81%.
Q: How do state and federal regulations affect prescription drug prices?
A: Regulations such as the Prescription Drug Price Transparency Act and the Inflation Reduction Act of 2022 can lead to upper payment limits or price negotiations, affecting drug prices.
Sources
- FDA: National Drug Code Database Background Information.
- Vizient: Vizient projects drug price inflation at 3.81%.
- ASPE: Comparing U.S. and International Market Size and Average Pricing for Prescription Drugs, 2017-2022.
- DailyMed: Label: TESTOSTERONE gel.
- Oregon Drug Price Transparency Program: Prescription Drug Price Transparency Results and Recommendations.