Last updated: March 1, 2026
What Is NDC 00234-0575 and Its Indications?
NDC 00234-0575 refers to a specific drug product registered with the National Drug Code (NDC) system. According to available data, this NDC corresponds to Bupivacaine Hydrochloride Injection, 0.75%.
This medication is primarily used for local anesthesia in surgical procedures, pain management, and epidural anesthesia. It belongs to the amide-type local anesthetics.
Market Overview
Current Market Size and Key Players
The global local anesthetics market was valued at approximately $2.2 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2030. The growth drivers include increased surgical procedures, innovations in formulations, and expanding applications.
The top competitors include:
- Hospira (Pfizer)
- Fresenius Kabi
- Teva Pharmaceuticals
- Mylan (subsidiary of Viatris)
- Hengrui Medicine
Market Share and Distribution
The US dominates the market with approximately 65% of sales, driven by high surgical volumes and preference for brand-name formulations. New entrants face patent barriers but benefit from generics' increasing inclusion.
Patent and Regulatory Status
No recent patent protection exists for Bupivacaine HCl injection. Multiple generic formulations compete in the market, with common approval dates dating back to the early 2010s.
Procurement and Usage Trends
The bulk of procurement occurs through hospital purchasing contracts and outpatient surgical centers. Usage volume correlates with general surgical volume, with an annual US anesthetic procedure volume exceeding 30 million.
Market Trends Impacting Future Growth
- Shift towards generic formulations: Patent expiration has led to increased generic competition, reducing prices.
- Innovations in delivery systems: Liposomal and sustained-release formulations are being developed, possibly commanding premium pricing.
- Regulatory landscape: Increasing oversight and quality standards influence manufacturing costs, affecting pricing.
Price Analysis
Current Pricing Data (US Market)
| Formulation |
Market Price per Vial |
Typical Dosage |
Packaging Size |
| Bupivacaine Hydrochloride 0.75% |
$10 - $15 |
7.5 mg/mL, 20 mL |
20 mL vial, single-use |
| Combination products (e.g., with epinephrine) |
$12 - $18 |
Same as above |
Variable |
Historical Price Trends (2018–2023)
- 2018: Average price for a 20 mL vial was approximately $12.50.
- 2020: Price decreased to around $11.20 following generic entry.
- 2023: Stabilized at $10.50 – $11 due to market saturation.
Price Projections (Next 5 Years)
| Year |
Estimated Price Range per 20 mL vial |
Assumptions |
| 2024 |
$10.00 – $11.00 |
Continued generic competition, no major patent activity |
| 2025 |
$9.80 – $10.80 |
Slight pricing pressure, possible new formulations |
| 2026 |
$9.60 – $10.60 |
Market saturation persists |
| 2027 |
$9.50 – $10.50 |
Potential for slight inflation from inflationary pressures |
| 2028 |
$9.40 – $10.40 |
Stable with minimal fluctuations |
Factors Influencing Price Movements
- Generics proliferation exerts downward price pressure.
- Supply chain disruptions or raw material shortages may alter costs.
- Development of new delivery systems or formulations could enable premium pricing.
- Regulatory costs may influence manufacturing expenses, potentially affecting prices.
Regulatory and Policy Impacts
- FDA approval pathways for biosimilars or combination formulations could reshape the competitive landscape.
- Price controls or changes in reimbursement policies, particularly under Medicare and Medicaid, might exert downward price pressure.
Key Takeaways
- NDC 00234-0575, corresponding to bupivacaine 0.75%, faces strong generic competition, resulting in declining and stabilizing prices.
- Total market size for local anesthetic injections is expected to grow modestly, driven by surgical demand.
- Price projections suggest slight decreases over the next five years, with potential for stabilization due to market maturity.
- Entry barriers are low due to expired patents; pricing is primarily influenced by manufacturing costs, competitive dynamics, and regulatory policies.
FAQs
1. What is the primary use of NDC 00234-0575?
It is used as a local anesthetic in surgeries and pain management procedures.
2. Is NDC 00234-0575 covered by patents?
No, the patent for this formulation expired before 2015, enabling widespread generic competition.
3. How do prices of this drug compare internationally?
International prices vary; in Europe, prices are generally lower due to different regulatory policies and healthcare systems.
4. What innovations could impact the market for this drug?
Development of liposomal or sustained-release formulations could command higher prices and expand the market.
5. How will regulatory changes affect prices?
Tighter regulations or approval of biosimilars can increase competition, potentially lowering prices further.
References
[1] MarketWatch. (2022). Local Anesthetics Market Size & Trends. MarketWatch.
[2] IQVIA. (2023). US pharmaceutical pricing and market share data.
[3] FDA. (2023). Drug Approvals and Patent Data.
[4] Grand View Research. (2022). Global Local Anesthetics Market Analysis.
[5] Medicare & Medicaid.gov. (2023). Drug reimbursement policies.
