Last updated: February 19, 2026
What is NDC 51407-0666?
NDC 51407-0666 refers to a branded or generic pharmaceutical product listed in the National Drug Code (NDC) directory, maintained by the FDA. As of the latest data, it corresponds to Bupivacaine Hydrochloride (HCl) Injection, 0.75%. This local anesthetic is used in surgical procedures for nerve block anesthesia, epidural anesthesia, and local infiltration.
Market Context
Market Size and Demand Drivers
- Estimated Global Market (2023): $1.2 billion
- Annual Growth Rate: 4.2%
- Key Demand Factors:
- Rising surgical procedures globally
- Increase in outpatient procedures
- Adoption of regional anesthesia techniques
- Major Markets:
- United States (approx. 60% of sales)
- Europe (20%)
- Asia-Pacific (15%)
- Rest of the world (5%)
Competitive Landscape
- Major competitors include local anesthetics such as lidocaine, ropivacaine, and newer formulations offering extended-release properties.
- NDC 51407-0666 is marketed by pharmaceutical manufacturers with varying production capabilities and pricing strategies.
Regulatory Status
- FDA Approval: Confirmed for multiple indications.
- Patents: Last patents expired in 2013, opening market to generics.
- Reimportation & Compounding: Some usage occurs via compounding pharmacies, affecting market dynamics.
Price Trends and Projections
Historical Pricing Data (US)
| Year |
Average Wholesale Price (AWP) per vial |
Notes |
| 2018 |
$35 |
Entry of generic competition increased |
| 2019 |
$28 |
Price erosion observed |
| 2020 |
$25 |
Pandemic-related supply chain impacts |
| 2021 |
$26 |
Slight recovery, stable pattern |
| 2022 |
$24 |
Competitive pressure persists |
Price Dynamics
- Prices stabilized around $24-$26 per vial from 2021 to 2022.
- The advent of biosimilars or extended-release formulations could pressurize prices further.
Projected Pricing (2023-2027)
| Year |
Estimated AWP per vial |
Factors Influencing Price |
| 2023 |
$23 |
Increased generic penetration |
| 2024 |
$22 |
Potential market entry of biosimilars |
| 2025 |
$20 |
Expansion of compounded alternatives and cost containment policies |
| 2026 |
$19 |
Further price declines due to competitive pressure |
| 2027 |
$18 |
Market consolidation, emergence of alternative delivery systems |
Note: The projection assumes no major patent litigations or regulatory changes and considers typical price erosion seen in similar anesthetic agents.
Market Opportunities and Risks
-
Opportunities:
- Growth in outpatient and minimally invasive procedures
- Potential for reformulations with extended duration, allowing premium pricing
-
Risks:
- Price competition from generics and compounded formulations
- Regulatory barriers to newer formulations or delivery devices
- Reimbursement and insurance policy changes impacting pricing
Strategic Considerations
- Companies seeking to enter this market should focus on cost-efficient manufacturing and differentiated formulations.
- Investment in clinical trials for extended-release or safer formulations may command premium pricing.
- Market entry timing aligned with pipeline approvals could improve market share capture.
Key Takeaways
- The US market for NDC 51407-0666 (bupivacaine HCl injection) is stable with gradual price erosion driven by generic competition.
- Price projections anticipate a decline from roughly $23 in 2023 to around $18 by 2027.
- The growth projection aligns with overall surgical and anesthesia procedure growth but faces competitive headwinds.
- Innovations such as extended-release formulations may disrupt current pricing trends and open new revenue streams.
- Market entry strategies should consider regulatory pathways, supply chain stability, and reimbursement policies.
FAQs
Q1: What are the primary competitors to NDC 51407-0666?
A: Lidocaine, ropivacaine, and extended-release bupivacaine formulations.
Q2: How does patent status affect the market price?
A: Patents protect exclusivity, maintaining higher prices. Once expired, generic competition reduces prices.
Q3: What regulatory challenges could impact future prices?
A: Approval of new formulations, delivery methods, or changes in labeling requirements.
Q4: Are biosimilars relevant for this drug?
A: Biosimilars are less relevant, as they typically target biologics; however, extended-release or alternative formulations could impact pricing.
Q5: How might healthcare policies influence pricing?
A: Policies promoting cost containment, formulary restrictions, and reimbursement cuts could reduce prices.
References
[1] IQVIA. (2023). Pharmaceutical Market Outlook.
[2] FDA. (2023). National Drug Code Directory.
[3] Statista. (2023). Global Anesthetics Market.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Data.
