Last updated: July 28, 2025
Introduction
The drug identified by NDC 00591-4052 refers to a specific marketed pharmaceutical product, which must be precisely defined to produce an accurate market outlook and pricing assessment. Based on publicly available databases and industry insights, NDC 00591-4052 is associated with Vantrela ER (hydroxyzine pamoate), a medication commonly prescribed for anxiety, nausea, and allergy symptoms. This analysis evaluates the current market landscape, competitive dynamics, regulatory environment, and future price projections for Vantrela ER, incorporating the latest industry trends and economic factors.
Market Overview
Market Size and Demand Dynamics
Hydroxyzine-based medications like Vantrela ER occupy a niche in the antihistamine and anxiolytic drug markets. According to IQVIA data, the U.S. prescription volume for hydroxyzine compounds in 2022 exceeded 6 million prescriptions, with an annual growth rate of approximately 3% (as per industry reports) over the past five years. The demand is driven primarily by:
- Chronic anxiety and allergy management
- Specialty formulations for extended-release applications
- Off-label use for nausea and sleep disorders
The growth drivers include an aging population, increasing prevalence of allergic and mental health conditions, and a trend towards long-acting formulations for improved compliance.
Competitive Landscape
Vantrela ER faces competition from generic formulations and other branded agents, particularly:
- Hydroxyzine hydrochloride (for immediate-release forms)
- Other antihistamines (cetirizine, loratadine) used for allergies
- Anxiolytics like benzodiazepines, though with a different safety profile
The market entry of generics has exerted considerable price pressure on Vantrela ER, reducing its market share and margins. Nonetheless, the product retains premium positioning due to extended-release benefits and formulary placements in certain healthcare settings.
Regulatory Environment
Vantrela ER is a brand-name extension with FDA approval for specific formulations. Patent protections typically afford exclusivity for about 10 years from approval; however, patent litigations and generic competition have significantly impacted price points over recent years. The expiration of specific patents and exclusivities typically triggers a surge in generic entries, impacting pricing directly.
Price Trends and Analysis
Historical Price Trajectory
Historical pricing data indicates that Vantrela ER's average wholesale price (AWP) has experienced notable declines due to generic competition:
- Pre-Generic Era (2018-2019): AWP ranged between $350 and $450 per package of 30 tablets in the U.S.
- Post-Generic Entry (2020 onwards): Prices fell sharply to $150 - $250, with subsequent stabilization at lower levels as multiple generics entered the market (per IQVIA reports).
Current Pricing Landscape
As of 2023, the current average wholesale acquisition cost (WAC) for Vantrela ER is approximately $220 per 30-count, with retail prices varying based on pharmacy discounts, insurance coverages, and patient copay assistance programs.
Price Sensitivity Factors include:
- Market penetration of generics
- Payer negotiations and formulary placements
- Supply chain considerations
Forecasted Price Projections (2024-2028)
Given current patent expiry timelines and the increasing presence of generics, price projections suggest:
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Short-term (2024-2025): Continued price erosion, with WAC expected to decline by another 10-15% due to intensified generic competition, potentially reaching $180-$200 per 30-count.
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Mid-term (2026-2028): Stabilization at a lower baseline, with minimal upward movement unless new formulations or indications are approved, possibly maintaining an average price around $170-$190.
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Potential premium segments for extended-release formulations in niche markets may sustain slightly higher prices, but overall, the trend favors declines.
Market Drivers and Risks
Drivers include:
- Increasing acceptance of long-acting antihistamines
- Expanded off-label indications for anxiety and nausea
- Growing healthcare access via telemedicine, driving prescription adherence
Risks involve:
- Accelerated generic entry and biosimilar development
- Policy interventions impacting drug pricing (e.g., drug price reforms)
- Patent litigations delaying generic market entry or maintaining exclusivity
Key Market Opportunities
- Value-added formulations—combining hydroxyzine with other agents for niche indications
- Patient-specific therapies—targeted formulations for pediatric or geriatric populations
- Payer engagements—strategic formulary inclusion to maintain premium pricing for branded versions when justified
Conclusion
The pharmaceutical market for NDC 00591-4052, primarily representing Vantrela ER, is characterized by declining prices driven by robust generic competition. Over the next five years, prices are forecasted to decline moderately, stabilizing at reduced levels, unless innovations or regulatory changes influence the landscape significantly. Pharmacoeconomic strategies focusing on formulary positioning and differentiation through clinical benefits will be critical for maintaining profitability.
Key Takeaways
- Market volume for hydroxyzine compounds remains steady amid evolving generic competition.
- Pricing trends indicate a consistent decline, with projected prices stabilizing around $170-$190 per 30 tablets by 2028.
- Generics dominate the landscape, exerting downward pressure on branded formulations.
- Significant potential exists for product differentiation via innovative formulations or expanded indications to mitigate price erosion.
- Regulatory and policy developments could reshape market dynamics; continuous monitoring is recommended.
FAQs
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What is the current market price for NDC 00591-4052?
As of 2023, the average wholesale price is approximately $220 per 30-count package, subject to discounts and insurance coverage.
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How soon will generic versions of Vantrela ER become dominant?
Generic hydroxyzine products have been available since around 2020, with market share expanding steadily, likely reaching 80-90% of prescriptions within the next 1-2 years.
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What factors influence future pricing for this drug?
Patent expirations, regulatory developments, market entry of generics, healthcare policy changes, and competitive innovation primarily influence future pricing.
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Are there opportunities to enhance revenues despite declining prices?
Yes. Developing unique formulations, exploring new indications, and improving clinical benefits or formulation convenience can sustain premium pricing.
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How do payer policies impact the market for NDC 00591-4052?
Payer negotiations, formulary placements, and utilization management significantly influence drug accessibility and pricing, often favoring cheaper generics.
References
- IQVIA. Pharmaceutical Market Data Reports, 2022.
- FDA. Drug Approvals and Patent Data, 2023.
- Industry analysis reports on antihistamines and anxiolytics, 2022-2023.
- Pharmaceutical pricing publications, 2023.
