Last updated: July 28, 2025
Introduction
The drug with NDC 00078-0248 primarily refers to Vasopressin Injection, a synthetic form of the naturally occurring hormone vasopressin, widely used for septic shock, vasodilatory shock, and diabetes insipidus. Its relevance in critical care settings and its patent status influence market dynamics and pricing strategies. This analysis aims to provide an in-depth review of the current market landscape, historical pricing trends, competitive forces, and future price projections grounded in industry data and forecast models.
Market Overview
Product Profile and Therapeutic Indications
Vasopressin injection is a critical vasopressor that constricts blood vessels, thereby increasing blood pressure in shock states. The drug's clinical utility remains significant, especially in intensive care units (ICUs) for vasodilatory and septic shock management. Its narrow therapeutic index and urgent clinical need for dosage management contribute to consistent demand.
Regulatory Status and Patent Considerations
Manufactured by established pharmaceutical companies, vasopressin formulations like NDC 00078-0248 are often off-patent or protected by limited exclusivity. The expiration of primary patents, combined with the availability of generic versions, has historically driven prices downward. However, shortages or manufacturing complexities can modulate these trends.
Current Market Landscape
Market Size and Demand Dynamics
The global vasopressin market was valued at approximately USD 100 million in 2022, with North America accounting for the majority share owing to high ICU utilization and stringent treatment protocols. Growing incidence of septic shock—estimated at more than 7 million cases annually worldwide—fuels demand, augmented by an aging population and rising prevalence of chronic conditions.
Competitive Environment
Multiple pharmaceutical companies produce vasopressin generics, notably Pfizer, Fresenius Kabi, and Hikma Pharmaceuticals. Market access, supply reliability, and formulation flexibility largely determine competitive advantages. The propitious environment for biosimilar and generic versions exerts downward pressure on prices.
Pricing Trends
Historically, vasopressin injection prices in the U.S. ranged from USD 0.15 to USD 0.30 per unit, with fluctuations driven by manufacturing costs, supplier competition, and hospital procurement contracts. The introduction of biosimilars and generic versions has accelerated price erosion over the past decade.
Price Trends and Historical Data
Data from the Medicaid Drug Content and commercial pharmacy pricing reports indicates a steady decline in unit costs from an initial high of approximately USD 0.60 per unit during the early 2010s to recent average prices below USD 0.20 per unit. Price reductions are more pronounced in hospital outpatient settings following increased generic supply.
Future Price Projections
Factors Influencing Future Pricing
- Patent Expiry and Generic Entry: Anticipated patent expiration (estimated circa 2025) for certain formulations could increase market entry of generics, intensifying price competition.
- Manufacturing and Supply Chain Dynamics: Supply chain disruptions, notably during the COVID-19 pandemic, temporarily increased prices due to shortages; such events can recur, causing price volatility.
- Regulatory and Policy Environment: Policy shifts toward promoting biosimilars to reduce healthcare costs could favor lower prices.
- Clinical Demand: Continued growth in ICU admissions will sustain demand, potentially offsetting downward price pressures through volume.
Forecast Model Assumptions
Using a compound annual decline rate (CAGR) approach based on historical trends, with an optimistic scenario of market saturation with generics, steady demand, and moderate manufacturing costs, prices may decline by approximately 5-8% annually over the next 5 years, reaching estimated price points of USD 0.10-0.15 per unit by 2028.
Alternatively, supply constraints or regulatory hurdles could slow decline or cause minor price increases temporarily, but overall, the trend favors stabilization at low prices.
Implications for Stakeholders
- Manufacturers: Focus on optimizing production costs, quality, and supply reliability to capitalize on volume sales rather than premium pricing.
- Buyers (Hospitals, PBMs): Develop strategic procurement avenues to secure favorable pricing, including participation in bulk purchasing agreements.
- Investors: Monitor patent landscapes and biosimilar pipelines, as new entrants could significantly alter market prices.
- Policy Makers: Support policies promoting transparent pricing and foster a competitive marketplace for critical care drugs.
Key Takeaways
- The vasopressin injection (NDC 00078-0248) market is mature, with prices trending downward due to increasing generic competition.
- Demand remains stable, driven by critical care needs, providing consistent volume but limited pricing power.
- Future price projections suggest a continued decline, reaching approximately USD 0.10-0.15 per unit by 2028, barring supply disruptions or regulatory hurdles.
- The anticipated patent expiry and entry of biosimilars will be pivotal in shaping future market pricing.
- Stakeholders should strategize around competitive procurement, cost reduction, and supply chain resilience.
FAQs
1. When is the patent for vasopressin formulations expected to expire?
Most patents associated with original vasopressin formulations are anticipated to expire around 2025, opening the market further to generics and biosimilars.
2. How does the availability of biosimilars impact vasopressin prices?
Biosimilar entry typically reduces prices due to increased competition; however, their impact depends on regulatory acceptance, manufacturing capacity, and clinical positioning.
3. What are the main drivers of demand for vasopressin injection?
Demand is primarily driven by critical care use in septic and vasodilatory shock management, increasing ICU admissions, and volume-based hospital procurement.
4. Are there supply risks associated with vasopressin manufacturing?
Yes, manufacturing complexities and recent supply chain disruptions, especially during the pandemic, have occasionally led to shortages, impacting pricing and availability.
5. How should healthcare providers prepare for future pricing trends?
Providers should develop strategic procurement plans, explore alternative formulations or suppliers, and participate in value-based negotiations to manage costs effectively.
Sources
- Market Research Future. Vasopressin Market - Forecast, Trends, Analysis. 2022.
- IQVIA. Prescription and Pricing Data. 2022.
- FDA Orange Book. Patent and Exclusivity Data for Vasopressin Formulations. 2023.
- Global Data. Critical Care Therapeutics Market Analysis. 2022.
- Healthcare Cost and Utilization Project (HCUP). ICU Utilization Data. 2022.
Note: All projections and analysis are based on current publicly available data and industry trends as of early 2023 and are subject to change based on regulatory, market, and supply chain developments.
