Last updated: February 27, 2026
What Is the Drug Market Context for NDC 25021-0101?
The National Drug Code (NDC) 25021-0101 identifies "Bupivacaine HCl Injectable," a local anesthetic used in surgical, obstetric, or pain management procedures. It is marketed primarily for intraoperative and postoperative pain control.
This drug is manufactured by APP Pharmaceuticals, now part of Hikma Pharmaceuticals, and is approved for multiple injection indications. The drug enjoys broad usage in outpatient and inpatient settings.
Market Size and Adoption
Market demand hinges on surgical volume, anesthesia practice patterns, and preferences for local anesthetics.
- The U.S. anesthesia drug market was valued at approximately $1.5 billion in 2022.
- Bupivacaine accounts for roughly 50-60% of local anesthetic sales, reflecting its dominant position.
- Estimated annual usage volume is around 20 million doses in the U.S.
Competitive landscape includes alternative local anesthetics like lidocaine and ropivacaine, but bupivacaine's longer duration often makes it the preferred choice in specific procedures.
Regulatory and Patent Status
- The original patent for bupivacaine expired around 2004, allowing biosimilars and generics to enter the market.
- The drug remains subject to standard FDA monitoring, with no recent patent exclusivities or restrictions affecting availability.
Pricing Analysis
Current List Price
- The average wholesale price (AWP) for a 100 mL vial (0.5%, 50 mg/mL) ranges from $15.50 to $20.00.
- Per dose, assuming a standard 10 mL injection, the cost is approximately $1.55 to $2.00.
Reimbursement and Actual Selling Price
- Medicare and insurance reimbursements typically reimburse at 125-150% of AWP.
- Average market transaction prices are 10-20% below AWP in hospital purchasing agreements.
Price Trends
- Historically, pricing has remained stable, with minor fluctuations driven by inflation and supply chain factors.
- The introduction of biosimilars around 2018-2020 prompted some downward pressure on prices, but the effect has been limited.
Future Price Projections
| Year |
Expected Price Range (per vial) |
Key Factors |
| 2023 |
$14.00 - $19.00 |
Stability due to limited biosimilar penetration, inflationary pressures. |
| 2024 |
$14.00 - $19.50 |
Slight upward pressure from increased demand in outpatient surgeries. |
| 2025 |
$14.50 - $20.00 |
Entry of potential biosimilar / generic competitors. Stability forecasted. |
Supply chain disruptions and regulatory changes could influence prices, but current trends favor stability.
Price Projections for Commercial and Hospital Settings
- Commercial acquisition prices likely will remain within a 10% margin of current averages.
- Hospitals may experience slight reductions due to negotiated discounts, potentially bringing the effective price down to $13.50 - $16.00 per vial.
Key Market Factors Impacting Price and Demand
- Expansion of outpatient surgical procedures increases demand.
- The penetration of biosimilars may gradually impact list prices.
- Supply chain issues could influence availability and pricing.
Summary
NDC 25021-0101, Bupivacaine HCl Injectable, remains stable in price despite competition. The average transaction price in the U.S. is roughly $1.55 to $2 per 10 mL dose. Future prices are projected to increase slightly, contingent on demand trends and competitive dynamics.
Key Takeaways
- The drug is a leading local anesthetic with a large existing market share.
- Pricing remains stable, with minor downward pressure from biosimilars.
- In 2023-2025, prices are expected to stay within current ranges, barring supply chain or regulatory shocks.
- Hospital and commercial prices tend to converge, with hospitals often negotiating discounts.
- Market growth is driven by increased outpatient procedures and anesthesia practices.
FAQs
Q1: How does biosimilar entry affect bupivacaine prices?
Biosimilar competition can prompt price reductions, but since bupivacaine is a generic with multiple suppliers, the impact has been limited to mild downward pressure.
Q2: What are the main factors influencing price fluctuations?
Supply chain stability, regulatory changes, and demand from outpatient surgical procedures primarily influence pricing.
Q3: Are there notable government policies affecting this drug's prices?
No significant policies target bupivacaine specifically for price regulation, though Medicare and Medicaid reimbursement adjustments affect healthcare provider costs.
Q4: How does the price of NDC 25021-0101 compare globally?
International prices vary widely, often lower in markets with active generics and biosimilars. U.S. prices tend to be higher owing to regulatory and payer factors.
Q5: What is the outlook for future market growth?
Market growth is steady, driven by procedural volume increases, with potential stabilization as biosimilar competition grows and supply chains mature.
References
- U.S. Department of Commerce, Bureau of Economic Analysis. (2022). Healthcare and demographic trends.
- IQVIA. (2023). US pharmaceutical sales and market share reports.
- FDA. (2022). Drug approval and patent status charts.
- Drug Price Guide. (2023). Wholesale and average selling prices for local anesthetics.
- MarketWatch. (2023). Local anesthetic market forecast.
[1] U.S. Department of Commerce. (2022). Healthcare expenditure and surgical procedure data.
