Last updated: February 21, 2026
What is the Drug Associated with NDC 67457-0266?
NDC 67457-0266 corresponds to Terlipressin. It is a vasoconstrictor primarily used in the management of hepatorenal syndrome (HRS) and distributive shock. Its approval status varies, but it is often used off-label or as an alternative treatment in specific markets.
Market Landscape
Market Players and Product Availability
- Generics Dominance: Several manufacturers produce generic terlipressin, with no single dominant player globally.
- Regional Variability: Approved mainly in Europe, Asia, and Latin America; limited or off-label use in the U.S.
- Regulatory Status:
- European Medicines Agency (EMA) approved Terlipressin for HRS in 2014.
- In the U.S., the FDA has not approved terlipressin for HRS; off-label use occurs.
- Other regulatory bodies vary in approval and reimbursement policies.
Key Market Drivers
- Rising incidence of liver cirrhosis and HRS globally.
- Increased recognition of terlipressin's efficacy, with clinical data supporting its use.
- Lack of alternative therapies for HRS, especially in regions with advanced healthcare systems.
Market Challenges
- Limited approval history in major markets like the U.S.
- Safety concerns, including ischemic complications.
- High dependence on regional prescribing patterns and off-label use.
Market Size Estimates
| Region |
Estimated Revenue (2022) |
CAGR (2022-2027) |
Notes |
| Europe |
$120 million |
4% |
Leading region, sole approved market at present |
| Asia-Pacific |
$80 million |
5% |
Growing due to increasing liver disease prevalence |
| Latin America |
$25 million |
3.5% |
Emerging market, lower penetration |
| U.S. |
<$10 million |
N/A |
No approved product, off-label and hospital use |
Competitive Outlook
- Leading generics manufacturers include Ferring Pharmaceuticals, Teva, and Hikma.
- Recent approvals or clinical trials by biotech firms may influence future market share.
- Price competition among generics remains intense, with prices averaging around $200–$300 per 10 mg vial in Europe.
Price Projections (2023–2027)
Current Pricing Overview
- European prices range from $200–$300 per 10 mg vial.
- U.S. hospital procurement prices vary widely due to off-label status and pharmacy markups.
- Regional pricing differences influenced by regulatory approval, reimbursement policies, and market competition.
Price Trend Drivers
- Patent and exclusivity status: No exclusivity for generics; price pressure remains high.
- Market penetration: Increased acceptance may lead to volume discounts.
- Manufacturing costs: Stability due to widespread generic manufacturing reduces price volatility.
- Regulatory approvals: Approval in new markets or expanded indications could increase prices temporarily.
Future Price Projections
| Year |
Price Range (per 10 mg vial) |
Key Factors |
| 2023 |
$200–$300 |
Existing competition, stable supply |
| 2024 |
$190–$290 |
Potential price reductions due to increased competition |
| 2025 |
$180–$275 |
Standardization of dosing and procurement practices |
| 2026 |
$170–$260 |
Market saturation, gradual price stabilization |
| 2027 |
$160–$250 |
Mature generic market, no notable price hikes |
Factors Influencing Price Decline
- Entry of new generic manufacturers
- Increased global supply capacity
- Consolidation among regional distributors
Strategic Implications
- Manufacturers should focus on expanding regions where approval is pending.
- Payers and healthcare providers may seek volume-based discounts given predictable demand.
- Cost reduction strategies could be essential to maintain margins amid price compression.
Regulatory and Market Expansion Opportunities
- Pursuing FDA approval in the U.S. could significantly expand market size.
- Label expansion for other indications might justify premium pricing.
- Clinical data supporting safety and efficacy could improve formulary acceptance and reimbursement levels.
Key Takeaways
- The drug's primary use in Europe and Asia positions it as a niche, high-demand medication.
- market size is approximately $225 million globally, with steady growth driven by regional increases in liver disease and HRS.
- Price reductions are expected to continue, maintaining an average around $200 per 10 mg vial by 2027.
- Market entry in the U.S. and other major countries could create growth opportunities.
- Competition among generics remains fierce, emphasizing cost management and regulatory strategies.
FAQs
Q1: What are the primary commercial markets for terlipressin?
A: Europe, Asia, and Latin America. Limited or off-label use in the U.S. and Canada.
Q2: What is the typical price range of the drug?
A: $200–$300 per 10 mg vial in approved markets; lower where competition and price pressure exist.
Q3: How likely is future price inflation?
A: Unlikely; prices tend to decline due to increasing generic competition and market saturation.
Q4: Can entering new markets boost revenue?
A: Yes; regulatory approval in the U.S. or other large markets can significantly expand revenue.
Q5: What factors could disrupt current market dynamics?
A: New therapeutic developments, regulatory changes, or supply chain shifts.
References
- European Medicines Agency. (2014). Terlipressin Summary of Product Characteristics. EMA.
- MarketWatch. (2022). Global vasoconstrictor market report.
- IQVIA. (2022). Pharmaceutical Market Data. IQVIA.
- U.S. Food and Drug Administration. (2022). Off-label drug use guidelines.
- Bloomberg Industry Reports. (2023). Generic drug pricing trends.
