Market Analysis and Price Projections for Diphenhydramine Hydrochloride (NDC: 72485-101)
Overview of Diphenhydramine Hydrochloride
Diphenhydramine hydrochloride, identified by the NDC 72485-101, is an antihistamine with anticholinergic and sedative properties. It is marketed by Armas Pharmaceuticals Inc. and is available in intramuscular and intravenous injection forms, each containing 50 mg of diphenhydramine hydrochloride per 1 mL solution[1][5].
Market Context
Generic vs. Branded Drugs
Diphenhydramine hydrochloride is a generic drug, which places it within the commodity-like generic drug industry. This sector is characterized by intense competition, mid-single-digit percent annual price erosion, and modest revenue growth[4].
Regulatory Environment
The FDA's regulatory environment plays a significant role in the pricing and availability of generic drugs. FDA inspections and potential price-fixing litigation can impact pricing strategies. For instance, ensuring compliance with FDA regulations is crucial for maintaining market presence[4].
Market Demand
The demand for diphenhydramine hydrochloride is driven by its use in treating various conditions such as allergic reactions, motion sickness, and as a sedative. The prevalence of these conditions influences the pricing and sales volume of the drug.
Pricing Dynamics
Competition
The presence of multiple generic versions of diphenhydramine hydrochloride drives prices down. As more manufacturers enter the market, the competition increases, leading to lower prices to maintain market share[4].
Regulatory Pressures
Regulatory pressures, including FDA inspections and potential litigation, can also influence pricing. Companies must balance their pricing strategies to comply with regulatory requirements while maintaining profitability[4].
Market Demand and Usage
The demand for diphenhydramine hydrochloride is relatively stable due to its widespread use in medical settings. However, changes in medical practices or the introduction of new treatments can impact demand and, consequently, pricing.
Current Pricing Trends
Wholesale Acquisition Costs (WACs)
The current pricing for diphenhydramine hydrochloride is influenced by its WACs, which are the prices at which wholesalers purchase the drug from the manufacturer. These costs are typically higher than the prices paid by end-users due to various discounts and rebates[2].
Price Projections
Annual Price Erosion
Given the competitive nature of the generic drug market, prices for diphenhydramine hydrochloride are expected to erode annually by around 3-5%. This trend is consistent with the current outlook for the pharmaceutical industry, where revenue growth is modest but stable[4].
Example Scenario
If the current price per unit of diphenhydramine hydrochloride is $50 (based on the 50 mg/mL concentration), here is a possible price projection over the next few years:
| Year |
Price per Unit |
| 2024 |
$50 |
| 2025 |
$47.50 |
| 2026 |
$45.13 |
| 2027 |
$42.87 |
| 2028 |
$40.71 |
This scenario assumes an annual price erosion of about 5%, which is within the expected range for generic drugs[4].
Revenue Growth and Cost Management
Revenue Growth
Despite the annual price erosion, the overall revenue for diphenhydramine hydrochloride may still grow modestly due to increased volume and market penetration. This growth is driven by the stable demand for the drug and potential increases in the number of patients treated[4].
Cost Management
Companies must balance their pricing to cover costs, including distribution, marketing (if applicable), and earning a reasonable return on investment. Ensuring compliance with FDA regulations and managing production costs efficiently are crucial for maintaining profitability[4].
Distribution and Marketing
Distribution Strategies
The distribution strategies for diphenhydramine hydrochloride can influence its pricing. Efficient distribution networks and minimal marketing expenses can help keep costs lower, allowing for more competitive pricing. For example, if the company does not engage in direct-to-consumer marketing or paid advertising, costs can be kept lower[4].
Impact of Broader Industry Trends
Digital Transformation and Innovation
The life sciences industry is undergoing significant transformation driven by digital advancements and scientific innovations. While these trends may not directly impact the pricing of diphenhydramine hydrochloride, they can influence the broader market dynamics and patient outcomes. For instance, advances in genomics and biomarkers could lead to more precise treatment options, potentially reducing the demand for certain generic drugs[3].
Pricing and Access
Pricing and access to drugs remain significant issues in the life sciences industry. Nearly half of C-suite executives expect pricing and access to significantly affect their strategies in 2025. This trend highlights the ongoing challenges in balancing innovation with affordability[3].
Key Takeaways
- Pricing Trends: Expect annual price erosion in the range of 3-5% due to market competition.
- Revenue Growth: Modest revenue growth is anticipated despite price erosion.
- Cost Management: Companies must balance pricing to cover costs and earn a reasonable return on investment.
- Regulatory Compliance: Ensuring compliance with FDA regulations is crucial for maintaining market presence.
- Market Demand: Increasing demand for drugs treating chronic conditions can support higher sales volumes.
FAQs
Q: What is the current dosage form and strength of diphenhydramine hydrochloride (NDC: 72485-101)?
A: Diphenhydramine hydrochloride is available in an injection solution form with a strength of 50 mg/mL[1][5].
Q: How does competition affect the pricing of diphenhydramine hydrochloride?
A: The presence of multiple generic versions drives prices down, leading to annual price erosion of around 3-5% due to intense competition[4].
Q: What are the key factors influencing the pricing of diphenhydramine hydrochloride?
A: Key factors include competition, regulatory pressures, and market demand. Efficient distribution and minimal marketing expenses also play a role in pricing strategies[4].
Q: How is the revenue for diphenhydramine hydrochloride expected to grow despite price erosion?
A: Revenue is expected to grow modestly due to increased volume and market penetration, driven by stable demand and potential increases in the number of patients treated[4].
Q: What broader industry trends could impact the market for diphenhydramine hydrochloride?
A: Trends such as digital transformation, innovation in genomics and biomarkers, and ongoing challenges in pricing and access to drugs could influence market dynamics and patient outcomes[3].
Sources
- FDA.report: NDC 72485-101 Intramuscular - FDA.report
- CMS: Medicare Drug Price Negotiation Program - CMS
- Deloitte Insights: 2025 life sciences outlook
- DrugPatentWatch: Latest drug prices and trends for NDC 00093-7664
- DailyMed: Label: DIPHENHYDRAMINE HYDROCHLORIDE injection, solution
