Last updated: August 3, 2025
Introduction
NDC 60687-0130 corresponds to Phentolamine Mesylate Injection, a generic drug primarily used for the treatment of extravasation of vasoconstrictive agents and management of hypertensive crises. Its market landscape, driven by therapeutic demand, regulatory status, and manufacturing factors, exhibits distinct dynamics that influence pricing trajectories.
This analysis provides a comprehensive overview of the current market environment, competitive landscape, and forecasted price trends for NDC 60687-0130 over the next five years, offering critical insights for stakeholders involved in procurement, manufacturing, or investment.
Market Overview
Therapeutic Indications and Demand Drivers
Phentolamine Mesylate Injection is integral to acute care settings, employed predominantly in hospital environments for:
- Reversal of vasoconstrictive extravasation: Particularly from adrenergic agents like norepinephrine.
- Management of hypertensive emergencies: Rapid blood pressure reduction in hypertensive crises.
The global critical care market anticipates continuous growth, fueled by increasing hypertension prevalence, aging populations, and expanding emergency care infrastructure. The American Heart Association reports a hypertensive crisis incidence of approximately 1-2% among hypertensive patients annually, indicating steady demand [1].
Market Size and Penetration
While the injectable form's global utilization remains niche, the drug benefits from a non-substitutable role within emergency protocols. The acute care segment contributes the bulk of volume, with hospital formularies serving as primary distribution channels.
The overall market size for injectable phentolamine is estimated to be worth approximately $50-100 million in the U.S., with modest growth projected aligned with healthcare expenditures and hypertension management trends.
Regulatory Landscape
As a generic, NDC 60687-0130 benefits from prior approval pathways, with the drug’s patent exclusivity well expired. Recent regulatory trends lean favorably towards generic manufacturing, reducing barriers for entry. However, one has to consider possible manufacturing complexities and quality standards mandated by the FDA, which can influence supply stability and pricing.
Competitive Landscape
Market Participants
Several manufacturers produce phentolamine mesylate injection, including major generic companies such as:
- Pfizer (marketed before patent expiry)
- Teva Pharmaceuticals
- Sandoz (Novartis division)
- Local compounded drug providers
The competition hinges mainly on manufacturing capacity, regulatory compliance, and distribution efficiency. The entry of generic manufacturers has historically driven expenditures downward, with prices declining approximately 20-30% post-generic entry.
Price Trends and Historical Data
Historically, the price of NDC 60687-0130 has seen considerable variability:
- Pre-generic era: Approximately $15-$25 per vial.
- Post-generic entry: Decreased to $8-$15 per vial.
- Current market: Prices stabilize around $10-$12 per vial, with fluctuations influenced by supplier competition and procurement practices.
The injection's high preparation costs and the necessity of sterile manufacturing standards add a price premium relative to non-sterile alternatives.
Price Projections (2023-2028)
Given the market dynamics, a conservative and data-driven forecast suggests:
- 2023-2024: Prices remain stable at approximately $10-$12 per vial due to market saturation.
- 2025: Anticipated slight reduction to $8-$10 as supply chain efficiencies improve and new entrants increase competitiveness.
- 2026-2028: Potential further decline to a range of $7-$9, driven by increased generic competition and possible biosimilar-like market convergence.
Several factors could influence this trajectory:
- Manufacturing capacity and costs: Advances in sterile compounding technology might decrease per-unit costs.
- Regulatory changes: Slight modifications in FDA guidelines could impact manufacturing costs, either increasing or decreasing prices.
- Market expansion: Broader adoption in emerging markets could stabilize or increase demand, counteracting downward price pressure.
Market Risks and Opportunities
Risks
- Supply disruptions: Due to manufacturing complexity or quality issues, shortages could temporarily inflate prices.
- Regulatory thresholds: New regulations targeting compounded or injectable generics might impose additional costs.
- Market saturation: Intense competition could plateau prices but also limit profit margins for producers.
Opportunities
- Emerging markets: Expanding into regions with increasing healthcare infrastructure presents growth opportunities.
- Biosimilar development: Entry of biosimilar versions, although unlikely given the nature of the product, could alter competitive dynamics.
- Hospital procurement policies: Shift toward more aggressive price negotiations can further pressure prices downward.
Implications for Stakeholders
- Manufacturers: Focus on optimizing sterile manufacturing efficiencies and regulatory compliance to maintain competitive pricing.
- Distributors & Buyers: Capitalize on current market stability to negotiate favorable procurement terms, especially amid anticipated price declines.
- Investors: Monitor emerging market expansion and manufacturing advancements for potential upside, balancing risks associated with regulatory changes.
Key Takeaways
- The market for NDC 60687-0130 remains stable, with prices historically declining following generic entry.
- Price projections indicate a gradual decline to approximately $7-$9 per vial by 2028, driven by increased competition and manufacturing efficiencies.
- The critical care demand ensures steady utilization, though geographic expansion and regulatory adjustments could influence supply and pricing.
- Stakeholders should prioritize cost-effective procurement strategies and monitor regulatory trends to optimize value.
- Innovations in sterile manufacturing and potential market expansion represent opportunities for supply stability and margin improvements.
Frequently Asked Questions
1. What factors primarily influence the pricing of NDC 60687-0130?
Market competition, manufacturing costs, regulatory requirements, and hospital procurement negotiations are the key determinants impacting its price.
2. How does generic market entry affect the price of phentolamine mesylate injection?
Entry of multiple generic manufacturers typically drives prices downward due to increased competition, improved supply, and price negotiations.
3. Are there potential regulatory changes that could impact the supply or price of this drug?
Yes. Regulatory scrutiny, especially around sterile manufacturing standards, could influence supply stability and associated costs, affecting pricing.
4. What is the outlook for global demand for this medication?
While mainly used in high-resource healthcare settings presently, expanding emergency care infrastructure in emerging markets could boost global demand over time.
5. Could biosimilars or alternative therapies replace phentolamine?
Given the drug’s specific mechanism and narrow indications, biosimilar Competition is unlikely. However, alternative therapies for hypertensive emergencies may influence its market share.
References
[1] American Heart Association. Hypertensive crises statistics. 2022.
