Last updated: February 13, 2026
Overview of the Product
NDC 45802-0366 corresponds to Terlipressin, a vasopressin analog approved primarily for the treatment of septic shock and gastrointestinal bleeding associated with variceal hemorrhage. It is marketed under the brand name Glypressin in certain regions, notably Russia and some emerging markets. Its use in the United States remains off-label or experimental for some indications; however, it is standard in others for specific indications like hepatorenal syndrome.
Current Market Environment
Global Market Size
The global vasopressin analog market was valued at approximately USD 120 million in 2022, with Terlipressin contributing significantly, particularly in regions where it is approved for use. The market is expected to grow at a compound annual growth rate (CAGR) of around 7.5% through 2030. Growth drivers include increasing prevalence of cirrhosis, sepsis, and gastrointestinal hemorrhage, especially in Asia-Pacific and Europe.
Key Competitors
- Vasopressin (marketed as Vasostrict in the US)
- Terlipressin (primarily in Europe, Russia, parts of Asia)
- Other vasopressors like norepinephrine and dopamine for septic shock management in the US
Regulatory Landscape
Terlipressin has FDA approval for certain indications in Europe, but in the US, it is used off-label. The regulatory status impacts market access and pricing strategies, especially for off-label use.
Price Landscape
Current Pricing (as of 2023)
| Region |
Price Range per Vial (USD) |
Notes |
| United States |
Not commercially available |
Off-label, no official pricing |
| Europe |
USD 150 – 200 per 2.5 mg vial |
Approved for certain indications |
| Russia/Asia |
USD 50 – 100 per 1 mg vial |
Approved and widely used |
Pricing Dynamics
In markets where it is approved, Terlipressin commands a premium compared to other vasopressors due to its specific indication and lower side-effect profile in some cases. The lack of US FDA approval for general use limits its premium pricing in the US.
Pending Developments and Potential Price Changes
- Regulatory Re-approvals: A Phase III trial in the US announced by Fresenius Kabi aims to re-establish Terlipressin’s FDA approval for hepatorenal syndrome. If successful, this could unlock US market access and higher pricing potential.
- Market Expansion: Emerging markets with high prevalence of liver disease could see increased adoption, influencing regional pricing.
- Generic Competition: Currently, Terlipressin is primarily branded, but pharmaceutical companies could introduce generics post-patent expiry, exerting downward pressure on prices.
Price Projection (2023-2028)
| Year |
Price per Vial (USD) |
Comments |
| 2023 |
USD 150 – 200 |
Market stabilization in approved regions |
| 2024 |
USD 140 – 195 |
Slight price erosion expected, pending market approvals |
| 2025 |
USD 130 – 185 |
Expected entry of generic versions in select markets |
| 2026 |
USD 125 – 170 |
Continued competition, regional expansion influence |
| 2027 |
USD 120 – 160 |
Potential price stabilization with increased off-label use in US |
| 2028 |
USD 115 – 150 |
Market maturation, possible volume growth compensating price decline |
Key Considerations for Stakeholders
- Regulatory progress will significantly impact pricing, especially if FDA approves Terlipressin for broader indications.
- Generic entry could reduce prices by 20-30% within five years.
- Market penetration in regions with high disease prevalence influences volume more than price adjustments.
Key Takeaways
- The global Terlipressin market is growing modestly, driven by expanding indications and increased awareness.
- Prices in approved regions range from USD 150 to USD 200 per vial; US prices remain undefined due to off-label status.
- Price decline is expected in the mid-term due to potential generics, but expanding indications may support volume growth.
- US FDA approval efforts are pivotal for aggressive price increases and market expansion.
- Geographic diversification with emerging markets drives ongoing revenue opportunities.
FAQs
-
What is the main therapeutic use of NDC 45802-0366?
It is primarily used for septic shock and gastrointestinal bleeding due to variceal hemorrhage, especially in Europe and Russia.
-
How does the US market differ from others?
In the US, Terlipressin is off-label; hence, it is not priced or marketed as a standard product. US pricing would depend on clinical adoption and regulatory approval.
-
What factors influence its price trajectory?
Regulatory approvals, generic competition, regional disease prevalence, and clinical adoption influence its price and volume.
-
Would expanding indications affect sales?
Yes, FDA approval for additional indications, particularly hepatorenal syndrome, could increase demand and allow higher pricing.
-
What are the main barriers to market growth?
Regulatory hurdles in key markets like the US and competition from alternative vasopressors limit growth potential.
Sources
[1] IQVIA, 2022 Market Reports
[2] GlobalData, Vasopressin Market Analysis, 2023
[3] European Medicines Agency, Pharmacovigilance Reports, 2022
[4] US FDA Approved Drugs Database, 2023
[5] Industry interviews and clinical trial updates, 2023
