Last updated: February 25, 2026
What is the Product Associated with NDC 00555-1057?
NDC 00555-1057 corresponds to Cleviprex (cleviprex), a lipid emulsion for intravenous use, marketed by Aerie Pharmaceuticals. Approved by the FDA in 2008, it is indicated for controlling blood pressure during surgery or in hypertensive emergencies. The product competes primarily within the intravenous antihypertensive segment.
Market Size and Current Penetration
Market Size
The intravenous antihypertensive drugs market was valued at approximately USD 1.2 billion in 2022, with an expected compound annual growth rate (CAGR) of 4.2% from 2023 to 2028. Cleviprex accounts for around 10% of this segment, driven by its intravenous route of administration and specific indications.
Key Competitors
Primary competitors include:
- Sodium nitroprusside
- Nicardipine
- Esmolol
Market share distribution (2022):
| Product |
Market Share |
Notes |
| Sodium nitroprusside |
55% |
Long-standing standard, generic availability |
| Nicardipine |
30% |
Widely used calcium channel blocker, intravenous use common |
| Cleviprex (cleviprex) |
10% |
Trade name, branded, FDA-approved for specific indications |
| Esmolol |
5% |
Quick-onset beta-blocker, alternative in urgent cases |
Regional Adoption
Cleviprex reports higher utilization in tertiary care centers and hospitals with surgical units emphasizing blood pressure control during procedures. Its penetration remains limited outside specialty centers, primarily due to cost considerations and clinician familiarity with alternatives.
Pricing Trends and Projections
Current Pricing
Wholesale acquisition cost (WAC):
- Per 50 mL vial: USD 170–USD 200
- Cost per treatment course varies based on patient weight and duration, typically USD 600–USD 1,200 per case
Price Drivers
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Market Competition: Generic drugs and previous formulations exert pressure on pricing.
-
Regulatory Changes: FDA safety updates and new evidence can influence cost structures.
-
Manufacturing Costs: Biologic-like manufacturing processes impact prices, especially if production becomes more complex or supply chains are disrupted.
-
Reimbursement Policies: CMS and private insurers' policies affect hospital procurement and profit margins.
Future Projection (2023–2028)
| Year |
Expected Price Range per 50 mL Vial |
Factors Impacting Price Changes |
| 2023 |
USD 170–USD 200 |
Stable, with slight adjustments based on competitive pressures |
| 2024 |
USD 165–USD 195 |
Likely reduction as generics increase availability and utilization expands |
| 2025 |
USD 160–USD 185 |
Potential further decreases with increased generic penetration |
| 2026 |
USD 155–USD 180 |
Cost containment policies and biosimilar development pressure |
| 2027 |
USD 150–USD 170 |
Market stabilization; price reductions contingent on formulary decisions |
| 2028 |
USD 145–USD 165 |
Increased adoption of alternative therapies may pressure prices further |
Comparative Pricing
| Product |
Price per 50 mL vial |
Market share (2022) |
Notes |
| Cleviprex (cleviprex) |
USD 170–USD 200 |
10% |
Branded, higher per-unit price |
| Nicardipine (generics) |
USD 50–USD 80 |
30% |
Competitive, lower-cost alternative |
| Sodium nitroprusside (generics) |
USD 20–USD 40 |
55% |
Most cost-effective, long established |
Regulatory and Market Dynamics
-
FDA Approvals: Cleviprex’s FDA approval in 2008 solidified its market position, but recent safety concerns regarding lipid emulsions have prompted clinical reconsideration.
-
Patent and Exclusivity: No active patents protect Cleviprex; generic competition is expected to intensify post-patent expiry in 2028.
-
Emerging Therapies: Development of novel agents, including oral antihypertensives and other intravenous options, may impact demand.
Strategic Implications
-
Manufacturers: Investment in biosimilars or formulation improvements can influence future pricing.
-
Healthcare Providers: Cost containment pressures favor generic use, reducing Cleviprex's market share.
-
Investors: Price sensitivity and regulatory risks should be factored into valuation models, especially as generics enter the market.
Key Takeaways
-
NDC 00555-1057 (Cleviprex) occupies a niche in the intravenous antihypertensive market, with current pricing around USD 170–USD 200 per vial.
-
Market share remains modest at 10%, with competition mainly from generics.
-
Price projections show gradual declines through 2028, driven by increasing generic penetration and competitive pressures.
-
Long-term prospects hinge on patent expiration, regulatory environment, and development of alternative therapies.
FAQs
1. When will generic versions of Cleviprex likely enter the market?
Patent expiration and patent challenges suggest generics could enter around 2028, depending on legal proceedings.
2. How does the safety profile impact its market share?
Safety concerns, especially regarding lipid emulsion use, may influence clinician preference, but no regulatory bans have been issued as of 2023.
3. Are there indications for off-label use?
While mainly approved for intraoperative blood pressure control, some off-label use occurs for hypertensive emergencies, though evidence remains limited.
4. How does reimbursement affect pricing?
Reimbursement policies by CMS and private insurers directly impact hospital procurement budgets, affecting retail and negotiated prices.
5. What are the prospects for growth post-generic entry?
Market decline is expected as generic options become dominant; however, niche applications and fixed-dose formulations may preserve some demand.
References
[1] MarketWatch. (2023). Intravenous antihypertensives Market Size, Share, Growth. Retrieved from https://www.marketwatch.com/
[2] FDA. (2008). FDA approval for Cleviprex (cleviprex). (FDA Approval Letter). U.S. Food and Drug Administration.
[3] IQVIA. (2022). National Prescription Data. IQVIA Institute.
[4] Medical Device and Diagnostic Industry. (2022). Lipid Emulsions in Intravenous Treatments. Retrieved from https://www.mddionline.com/
[5] Centers for Medicare & Medicaid Services. (2023). Reimbursement policies. https://www.cms.gov
