Introduction
Diphenhydramine hydrochloride, with the NDC code 72485-101, is an antihistamine used for various medical indications, including allergic reactions, sedation, and as an antiemetic. Here, we will delve into the market analysis and price projections for this drug.
Market Overview
Diphenhydramine hydrochloride is a widely used medication, available in multiple formulations, including intramuscular and intravenous injections. It is labeled and distributed by Armas Pharmaceuticals Inc. under an Abbreviated New Drug Application (ANDA)[1][4].
Usage and Demand
The drug is commonly prescribed for conditions such as allergic reactions, insomnia, and motion sickness. Its broad therapeutic applications ensure a steady demand in the healthcare market. The demand is further supported by its use in both acute and chronic conditions, making it a staple in many medical settings.
Pricing Dynamics
Wholesale Acquisition Cost (WAC)
The pricing of diphenhydramine hydrochloride is influenced by the WAC, which is the list price set by the manufacturer. For generic drugs like diphenhydramine hydrochloride, WAC prices have generally remained static or decreased over the past few years. However, the average amount paid by payers, including member cost share, can be significantly higher due to the markup from WAC to the Average Wholesale Price (AWP)[3][5].
Rebates and Discounts
Pharmacy Benefit Managers (PBMs) play a crucial role in the pricing dynamics by negotiating rebates with manufacturers. For generic drugs, rebates are typically minimal, around 0.64% of the WAC, which is significantly lower than those for brand drugs[3].
AWP and Markup
The AWP for generic drugs often does not change concurrently with WAC changes, leading to a high markup from WAC. This can result in payer-paid amounts that are several times higher than the WAC, despite any decreases in the WAC[3][5].
Price Projections
Historical Trends
Historically, the prices of generic drugs have shown a trend of static or decreasing WACs, but with increasing average amounts paid by payers due to the AWP markup. This trend is expected to continue, with the average percent of increase in prices remaining above the consumer price index (CPI-U)[3][5].
Future Outlook
Given the current market dynamics, here are some key projections:
- WAC Stability: The WAC for diphenhydramine hydrochloride is likely to remain stable or decrease slightly, following the general trend for generic drugs.
- AWP Markup: The AWP is expected to remain high relative to the WAC, leading to higher payer-paid amounts.
- Rebate Impact: The minimal rebates for generic drugs will continue to have a negligible impact on the overall cost to payers.
- Payer Costs: The average amount paid by payers, including member cost share, is expected to increase due to the AWP markup, despite any WAC decreases.
Competitive Landscape
The market for diphenhydramine hydrochloride is competitive, with multiple manufacturers producing generic versions. This competition can drive prices down, but the AWP and rebate structures often mitigate these effects[3].
Regulatory Environment
Regulatory changes and transparency reports, such as those from the Maine Health Data Organization, can influence pricing by highlighting trends and prompting policy changes. However, these changes are typically slow to implement and may not significantly impact the pricing of established generic drugs like diphenhydramine hydrochloride in the short term[3][5].
Consumer and Payer Impact
The high markup from WAC to AWP can significantly affect consumers and payers, especially those without comprehensive insurance coverage. This can lead to higher out-of-pocket costs and increased financial burden on healthcare systems.
Key Takeaways
- Stable WAC: The WAC for diphenhydramine hydrochloride is expected to remain stable or decrease slightly.
- High AWP Markup: The AWP will likely remain high relative to the WAC, increasing payer-paid amounts.
- Minimal Rebates: Rebates for generic drugs will continue to be minimal.
- Competitive Market: The market is competitive, but this may not significantly lower prices due to the AWP and rebate structures.
- Regulatory Influence: Regulatory changes may influence pricing trends but are slow to implement.
FAQs
Q: What is the current NDC code for diphenhydramine hydrochloride injection?
A: The NDC code for diphenhydramine hydrochloride injection is 72485-101[1][4].
Q: Who is the labeler and distributor of diphenhydramine hydrochloride?
A: The labeler and distributor is Armas Pharmaceuticals Inc.[1][4].
Q: What are the common uses of diphenhydramine hydrochloride?
A: It is used for allergic reactions, sedation, and as an antiemetic[4].
Q: How do rebates affect the pricing of generic drugs like diphenhydramine hydrochloride?
A: Rebates for generic drugs are typically minimal and do not significantly reduce the cost to payers[3].
Q: What is the expected trend in the average amount paid by payers for diphenhydramine hydrochloride?
A: The average amount paid by payers is expected to increase due to the high AWP markup, despite any WAC decreases[3][5].
Sources
- FDA.report: NDC 72485-101 Intramuscular - FDA.report
- Missouri Department of Social Services: Jan-2023 MISSOURI SPECIALTY MAC NAME OF DRUG Strength ...
- Maine Health Data Organization: MHDO Rx Transparency Report_221213.pdf
- DailyMed: Label: DIPHENHYDRAMINE HYDROCHLORIDE injection, solution
- Maine Health Data Organization: MHDO Rx Transparency Report_221213.pdf
