Last updated: March 1, 2026
What Is the Drug Identified by NDC 00116-2001?
NDC 00116-2001 corresponds to Vasopressin Injection, USP, marketed under brand names such as Vasostrict. This synthetic hormone is predominantly used for vasoconstriction in cases like vasodilatory shock, cardiac arrest, and diabetes insipidus. It is available in multidose vials, typically 20 units/mL.
Current Market Landscape
Market Size and Demand Drivers
- The global vasopressin market was valued at approximately $200 million in 2022.
- The compound is mainly used in acute care hospitals, emergency medicine, and critical care units.
- Key factors influencing demand include the incidence of septic shock and vasodilatory shock, which are projected to grow at a compound annual growth rate (CAGR) of slightly above 4% through 2028.
Competitive Environment
| Competitors |
Market Share |
Formulations and Brands |
Pricing Strategy |
| Fresenius Kabi |
45% |
Vasostrict |
Competitive, based on hospital contracts |
| Mylan (now part of Viatris) |
25% |
Vasopressin Injection |
Lower price due to volume sales |
| Others (Sagent, Wockhardt) |
15% |
Various generics |
Pricing varies, usually lower |
Regulatory Status and Approvals
- FDA approval since 1968.
- Used off-label in reversible vasoconstriction during surgical procedures.
- Market entry of biosimilars is slow due to manufacturing complexity, but biosimilar candidates are under development.
Pricing Trends
- The average wholesale price (AWP) per 20-unit vial stands around $50-$70.
- Contract prices for hospitals are often lower, sometimes below $40 per vial.
- Prices have remained stable in recent years due to limited pressure from biosimilar competition.
Price Projections
Short-term (1-2 years)
- Stability Expected, with minor fluctuations driven by supply chain costs and hospital purchasing dynamics.
- Wholesale prices projected to stay within $45-$70 per vial.
- No immediate biosimilar entry anticipated within this period.
Mid- to Long-term (3-5 years)
- Potential for slight decrease in generic and biosimilar prices, should biosimilars gain approval and market share.
- Biosimilar development pipelines include candidates that could enter the market by 2026-2028, possibly reducing the average price by 10-20%.
- Hospital negotiations and supply chain efficiencies may further compress margins and prices.
Factors Influencing Future Prices
- Biosimilar Approvals: US FDA approvals could impact pricing; the first biosimilar for vasopressin is not yet approved.
- Regulatory Changes: Increased pressure on pricing mechanisms and increased use of value-based pricing models.
- Manufacturing Costs: Supply chain disruptions or raw material cost fluctuations influence wholesale prices.
- Market Demand: Rising cases of septic shock due to aging populations or pandemic-related health issues.
Summary Table of Price Trends
| Year |
Wholesale Price Range (per vial) |
Notes |
| 2022 |
$45 - $70 |
Stable; existing competition |
| 2023 |
$45 - $70 |
Stable; no biosimilar entry |
| 2024 |
$43 - $67* |
Slight downward pressure anticipated |
| 2025 |
$41 - $65* |
Increased biosimilar development might impact prices |
| 2028 |
$39 - $61* |
Potential biosimilar approval and market entry |
(*) Adjustments based on anticipated biosimilar impact.
Key Market Risks
- Biosimilar Competition: Delay or failure to gain approval could sustain current pricing.
- Regulatory Changes: Government interventions to control drug spending could cap prices.
- Manufacturing Challenges: Supply chain issues may cause price volatility.
- Market Demand Variability: Fluctuations in incidence rates of shock conditions could alter demand.
Key Takeaways
- The current market for vasopressin injection remains stable with prices between $45 and $70 per vial.
- Biosimilar development is ongoing, with potential to reduce prices by up to 20% over the next five years.
- Market growth is driven by increasing critical care needs, but competitive pressures and regulatory policies could influence future pricing.
- Hospital contracts often secure lower purchase prices than the wholesale average.
- Supply chain stability and biosimilar approval will be primary factors affecting future price trends.
FAQs
Q1: When might biosimilar vasopressin products enter the US market?
A1: The timeline is uncertain; no biosimilar vasopressin has received FDA approval as of early 2023. Likely between 2026 and 2028 if candidates succeed in regulatory review.
Q2: What is the main use case for vasopressin injection in hospitals?
A2: It is primarily used for vasodilatory shock, cardiac arrest, and diabetes insipidus to induce vasoconstriction.
Q3: How are prices for vasopressin injection determined in hospitals?
A3: Prices are established through negotiations, with hospitals often obtaining discounts from suppliers, making the actual purchase price lower than the average wholesale price.
Q4: How could regulations impact vasopressin pricing?
A4: Policies aimed at controlling healthcare costs could introduce price caps or increase dependence on biosimilars, which might reduce prices.
Q5: What are the main drivers for growth in vasopressin demand?
A5: Increasing incidence of septic and vasodilatory shock, aging populations, and expanding use in surgical procedures.
References
[1] MarketWatch. (2023). Vasopressin Market Size, Share & Trends.
[2] U.S. Food and Drug Administration. (2023). Biosimilar product approvals.
[3] IQVIA. (2022). US Hospital Purchasing Data.
[4] EvaluatePharma. (2022). Biopharmaceuticals and Biosimilars Market Forecasts.
