Last updated: February 22, 2026
What Is the Drug Identified by NDC 51407-0460?
The National Drug Code (NDC) 51407-0460 corresponds to Bupivacaine HCl in a 0.5% concentration, supplied by Hikma Pharmaceuticals. Bupivacaine is a local anesthetic used primarily in surgical procedures, labor, and postoperative pain management. Its administration involves infiltration, nerve blocks, epidural, and caudal blocks.
Market Overview
Market Size and Key Players
The global local anesthetics market is projected to reach USD 4.7 billion by 2026, with a CAGR of approximately 4.2% from 2021 onwards (Grand View Research, 2022). Bupivacaine holds a significant share due to its widespread clinical use and patent expirations.
Major competitors include:
- Hospira (Pfizer)
- Hikma Pharmaceuticals
- Sun Pharmaceutical
- Pfizer (original patent holder for marcaine)
- Mylan
Market Trends
- A higher demand for outpatient procedures drives increased use of regional anesthesia.
- Shift toward generic formulations due to patent expiry increases market competition.
- Emerging markets see rapid growth due to expanding healthcare infrastructure.
Regulatory Environment
- The U.S. Food and Drug Administration (FDA) has approved multiple generics for Bupivacaine (including Hikma's version), increasing access and usage.
- Price competition intensified post-patent expiration, driving down prices.
Pricing Analysis
Current List Prices
Hikma's Bupivacaine 0.5% (NDC 51407-0460):
| Package Size |
Wholesale Acquisition Cost (WAC) |
Average Wholesale Price (AWP) |
| 50 mL vial |
USD 30.00 |
USD 36.00 |
| 100 mL vial |
USD 55.00 |
USD 66.00 |
Note: WAC and AWP are pricing benchmarks; actual prices may vary by retailer and purchaser.
Price Trends
- Since 2019, generic Bupivacaine prices have declined roughly 20-25% due to increased competition.
- Recent supply chain disruptions have caused temporary price volatility but stability is restoring.
- Prices for the same formulation from other manufacturers are comparable, indicating a highly competitive market.
Price Projections (Next 1-3 Years)
- Expected steady decline of 3-5% per annum in WAC prices, driven by increased generics and efficiency in manufacturing.
- Possible stabilization at current levels if demand plateaus or supply chain issues persist.
- The introduction of biosimilar or alternative formulations could further suppress prices.
Clinical and Economic Factors Influencing Future Prices
- Regulatory changes: New safety guidelines could impact manufacturing costs or limit formulations.
- Market penetration: Expansion into emerging markets may create demand but could also drive pricing pressures through local procurement negotiations.
- Innovation: Development of sustained-release formulations or new delivery methods may command premium pricing but are unlikely for a well-established generic.
Summary
The drug corresponding to NDC 51407-0460 is a generic Bupivacaine 0.5%, with a mature market characterized by high competition and declining prices. Current wholesale prices hover in the USD 30-66 range per vial, with margins expected to diminish gradually. Price resilience remains unlikely, barring significant innovations or regulatory changes.
Key Takeaways
- NDC 51407-0460 is Hikma's generic Bupivacaine 0.5%.
- The market is highly competitive, with prices trending downward.
- Forecasted price decline of 3-5% annually over the next three years.
- Rising demand due to procedural volume increases supports steady market size.
- Price stability depends on supply chain factors, regulatory impacts, and potential product innovations.
FAQs
1. How does Hikma’s pricing compare to other generics?
Hikma's prices are aligned with competitors, with minor variations typical in generic drug markets. Price levels are generally within a 10% range among different manufacturers.
2. Are there upcoming regulatory changes that could affect prices?
Regulatory agencies are reviewing safety updates for local anesthetics; no immediate major changes expected that would significantly impact pricing.
3. What factors could accelerate price declines?
Increased market entrants, supply chain improvements, or healthcare policy measures favoring cost reductions could accelerate price decreases.
4. Could new formulations impact the market for this drug?
Yes. The development of long-acting or novel delivery systems may shift demand, but such products are not currently in late-stage development.
5. Is there room for price increases in the near term?
Limited; price increases are unlikely unless supply shortages occur or regulatory constraints increase manufacturing costs.
Citations
- Grand View Research. (2022). Local Anesthetics Market Size, Share & Trends Analysis Report. Retrieved from https://www.grandviewresearch.com/industry-analysis/local-anesthetics-market
- U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations.
