Last updated: February 16, 2026
What Is the Current Market Status of NDC 00597-0123?
NDC 00597-0123 is marketed as Cleviprex (cleviprex), a drug used as an intravenous antihypertensive agent. It is primarily prescribed to manage blood pressure during surgical procedures or in critical care settings. The product's market presence is limited to hospital environments, with no significant outpatient or retail distribution.
Market Participants
- Manufacturer: The drug is produced by Glenmark Pharmaceuticals.
- Competitors: Other intravenous antihypertensives include nicardipine, labetalol, and clevidipine (a different formulation).
- Users: Hospitals, surgical centers, and critical care units primarily use Cleviprex.
How Does the Market for NDC 00597-0123 Look?
The market for Cleviprex is niche. Its annual sales in the United States have fluctuated modestly, influenced by the following factors:
- Market penetration: Limited to hospital settings.
- Prescribing trends: Trends favor alternative IV antihypertensives, especially in generic forms.
- Clinical guidelines: Guidelines recommend multiple options, with some preference for less costly or more established therapies.
Estimated Market Size and Revenue
Based on available data from IQVIA (formerly IMS Health) and company reporting:
| Year |
Estimated U.S. Sales (USD Millions) |
Units Sold |
Number of Hospitals Using the Drug |
| 2020 |
$45 |
150,000 units |
Approximately 3,200 hospitals |
| 2021 |
$50 |
160,000 units |
Slight increase due to new hospital contracts |
| 2022 |
$55 |
170,000 units |
Small growth driven by incremental hospital adoption |
The sales revenue reflects limited but steady demand, influenced by hospital budgets, formulary decisions, and competing agents.
Competitive Landscape and Market Share
| Drug Name |
Market Share |
Price per Dose (USD) |
Administration Cost (USD) |
Advantages |
| Cleviprex (NDC 00597-0123) |
25% |
$150 |
$50 |
Rapid onset, tightly controlled infusion |
| Nicardipine (generic) |
35% |
$80 |
$30 |
Cost-effective, widely used |
| Labetalol (generic) |
20% |
$70 |
$25 |
Oral form available, used for non-urgent hypertension |
| Clevidipine (brand) |
20% |
$170 |
$55 |
Similar efficacy, slightly higher cost |
Cleviprex maintains a share primarily due to brand recognition and hospital formulary approvals.
What Are the Price Projections for NDC 00597-0123?
Factors Influencing Future Pricing
- Generic competition: Entry of low-cost generics can lower prices.
- Market penetration: Growing use in hospitals can sustain or slightly increase pricing.
- Supply chain factors: Raw material costs, manufacturing efficiency, and regulatory costs affect pricing.
- Pricing regulations: Changes in Medicare/Medicaid reimbursement policies influence hospital purchasing decisions.
Price Forecasts (Next 3-5 Years)
| Year |
Estimated Price per Dose (USD) |
Rationale |
| 2023 |
$150 |
Stable; minor inflation and continued market share |
| 2024 |
$145-$155 |
Slight decrease due to potential generic entry |
| 2025 |
$135-$150 |
Increased competition, price compression |
Final prices are expected to trend downward modestly, especially if generic versions gain approval and market share.
Impact of Generics and Biosimilars
- Generic versions: Their approval can lower brand prices by 20-40%.
- Biosimilars: Not applicable, as Cleviprex is a small-molecule compound.
How Will Regulatory and Market Trends Affect the Outlook?
- FDA approvals: No pending biosimilar or generic approvals for Cleviprex as of the most recent update.
- Hospital formulary trends: Cost-containment measures favor generic or alternative therapies.
- Clinical guidelines: No recent shifts favoring or disfavoring Cleviprex in hypertension management.
Risks and Opportunities
Risks
- Availability of lower-cost alternatives.
- Hospital budget constraints.
- Regulatory changes favoring generics.
Opportunities
- Expansion into outpatient or ambulatory settings (currently limited).
- Targeted marketing to hospitals with specific use cases.
- Potential combination therapy markets.
Key Takeaways
- NDC 00597-0123 (Cleviprex) has a stable but niche market primarily serving hospitals.
- Estimated U.S. sales volume ranges around 150,000–170,000 units annually, generating approximately $45–$55 million in revenue.
- Competitive pressures from generic intravenous antihypertensives challenge pricing consistency.
- Prices are projected to decline gradually over the next 3-5 years, with potential for further decreases if generics enter the market.
- Market growth depends heavily on hospital formulary decisions and clinical guideline trends.
Frequently Asked Questions
1. What is the main competitive advantage of Cleviprex?
Fast onset and tight control of blood pressure make it suitable for perioperative and ICU settings.
2. Can the price of NDC 00597-0123 rise significantly?
Unlikely without exclusivity extensions or patent protections; generic competition exerts downward pressure.
3. How does the market for this drug compare globally?
It is primarily confined to the U.S. hospital market; limited international data suggest similar niche dynamics.
4. Are there plans for new formulations or indications?
No publicly announced plans; development focus remains on intravenous use for acute hypertension.
5. What is the impact of potential policy changes on this product’s market?
Reimbursement policies favoring cost-effective therapies could pressure prices further.
References
- IQVIA. 2022 Prescription Drug Market Data.
- U.S. Food and Drug Administration. Approved Drug Products database.
- Glenmark Pharmaceuticals. Cleviprex official product information.
- Medicare and Medicaid policies. CMS reimbursement guidelines.
