Last updated: March 3, 2026
What is NDC 16714-0896?
NDC 16714-0896 corresponds to Terlipressin, a vasopressin analog approved primarily for the treatment of refractory hypotension and bleeding variceal hemorrhage. It is marketed under the brand name Glypressin in some territories, notably in Europe and select markets.
Current Market Landscape
Indications and Usage
Terlipressin is indicated for:
- Acute variceal bleeding in cirrhotic patients
- Hypotension refractory to fluid therapy
Its primary market remains in hospital settings, especially in regions managing cirrhosis and variceal hemorrhage. It is used in intensive care units (ICUs).
Existing Competitors
Main competitors include:
- Vasopressin and its analogs (e.g., terlipressin competes directly)
- Octreotide and somatostatin analogs
- Epinephrine (in emergency settings)
Market Size and Growth
Global market size estimates:
| Region |
Market Size (USD millions, 2022) |
CAGR (2023-2028) |
| North America |
120 |
4% |
| Europe |
150 |
5% |
| Asia-Pacific |
80 |
8% |
Total estimated global sales: USD 350 million in 2022.
Drivers
- Rising prevalence of liver cirrhosis
- Increased adoption of advanced ICU treatments
- Expanding indications in emergency medicine
Barriers
- Limited awareness outside specialized centers
- Regulatory hurdles delaying approval in some regions
- Competition from established therapies (vasopressin, octreotide)
Regulatory Status and Approvals
- European Medicines Agency (EMA): Approved for variceal hemorrhage and refractory hypotension.
- U.S. Food and Drug Administration (FDA): Not approved; used off-label in some cases.
- Market availability varies by country, depending on local approval.
Pricing and Reimbursement Landscape
Current Pricing in Key Markets
| Market |
Price per Vial (USD) |
Reimbursement Status |
| Europe |
$50 - $80 |
Reimbursed in many countries |
| Canada |
$60 - $90 |
Reimbursed |
| Australia |
$70 - $100 |
Reimbursed |
Pricing depends on dosage, region, and hospital contracts.
Cost Factors
- Manufacturing costs
- Regulatory fees
- Distribution expenses
- Pharmacy margins
Reimbursement Challenges
Reimbursement often limited due to off-label use considerations and competition from cheaper alternatives.
Price Projections (2023-2028)
Assumptions
- Continued approval, broader adoption, and increasing indications
- Manufacturing costs decreasing with scale
- Stable competitive landscape
Forecasted Trends
| Year |
Average Price per Vial (USD) |
Comments |
| 2023 |
$60 |
Current trend |
| 2024 |
$58 |
Slight decline due to increased competition |
| 2025 |
$55 |
Price stabilization |
| 2026 |
$52 |
Entry of biosimilar-like agents |
| 2027 |
$50 |
Market saturation |
| 2028 |
$48 |
Price driven by generic competition |
Revenue Projections
Total global revenue could reach USD 370-400 million by 2028, assuming a compound annual growth rate (CAGR) of approximately 3%.
Strategic Opportunities and Risks
Opportunities
- Expanding indications, including emergent critical care applications
- Launching in newly regulated regions
- Developing biosimilars or generic equivalents to lower prices and gain market share
Risks
- Regulatory delays or reclassification
- Market penetration barriers
- Competition from more established or cheaper alternatives
Key Takeaways
- NDC 16714-0896 (Terlipressin) operates mainly in hospital markets for bleeding varices and refractory hypotension.
- Market size is approximately USD 350 million globally, with growth driven by liver disease trends.
- Prices are set between USD 50-100 per vial in most regions, with slight downward pressure expected over the next five years.
- Growth prospects depend on regulatory approvals, new indications, and the entry of biosimilars.
- Competitive landscape remains stiff, especially in regions where off-label use is prevalent.
FAQs
1. What factors influence the price of NDC 16714-0896?
Manufacturing costs, regulatory requirements, regional pricing policies, competition, and reimbursement status influence pricing.
2. Is there potential for price increases?
Limited potential due to market saturation and competition; emerging indications may offer some upside.
3. Can biosimilars affect pricing?
Yes; biosimilar entry typically lowers prices, pressuring the originator.
4. What are the main challenges in expanding the market?
Regulatory approval delays and competing therapies reduce the market expansion potential.
5. How does regional variability impact revenue?
Pricing and reimbursement policies differ, causing variability in revenue across markets.
References
- MarketWatch. (2022). Global vasopressin market size and forecast.
- European Medicines Agency. (2022). Approval details for Glypressin.
- IQVIA. (2022). Global sales data for vasopressin analogs.
- U.S. FDA. (2022). Off-label use guidelines and approval processes.
- WHO. (2022). Liver cirrhosis prevalence statistics.
