Last updated: February 15, 2026
What is NDC 23155-0287?
NDC 23155-0287 identifies a specific drug product registered in the National Drug Code system. This NDC code corresponds to Bupivacaine HCl Injectable, used primarily for local and regional anesthesia. The product's formulation, manufacturer, and packaging specifics influence its market dynamics.
Market Size and Demand Drivers
Current Market Size
- The global local anesthetics market was valued at approximately USD 3.6 billion in 2022.
- The U.S. accounts for roughly 55% of this market, translating to an estimated USD 1.98 billion.
- The segment dominated by bupivacaine, including injectable formulations like NDC 23155-0287, accounts for around 40% of the local anesthetics market.
Demand Drivers
- Increased outpatient and minimally invasive procedures fuel the growth.
- Rising global surgical volume; approximately 310 million surgeries occur annually worldwide.
- Growing geriatric population increasing demand for anesthesia services.
- COVID-19 pandemic temporarily disrupted elective surgeries, but recovery trends show stabilization with increased procedural volume.
Market Trends
- Expansion into regional blocks and shoulder surgeries.
- Development of extended-release formulations.
- Increased focus on safety profiles, leading to innovations in formulation.
Competitive Landscape
Major Players
| Company |
Market Share (Estimate) |
Key Products |
| Hospira (Pfizer) |
~35% |
Bupivacaine HCl Injectable (generic) |
| Teva |
~20% |
Bupivacaine Products |
| Mylan |
~15% |
Bupivacaine formulations |
| Others |
~30% |
Various generics and biosimilars |
The market for generic bupivacaine injectable is highly consolidated, with the top three companies controlling approximately 70% of sales.
Regulatory and Patent Status
- No recent patents protecting Bupivacaine formulations in the U.S.
- FDA approval dates trace back to the 1980s and 1990s, with multiple generics approved post-patent expiration.
- Market entry barriers are low for generic manufacturers.
Price Trends and Projections
Historical Pricing Data
- Average wholesale acquisition cost (WAC) for a 50 mL vial of Bupivacaine HCl injectable (10 mg/mL concentration) has fluctuated between USD 4.50 and USD 7.00 over the past five years.
- Prices are sensitive to manufacturer competition, with recent generic launches leading to downward pressure.
Current Pricing (Q1 2023)
| Formulation |
Average WAC per 50 mL vial |
Range (USD) |
| Bupivacaine HCl injectable |
USD 5.50 |
USD 4.75–USD 6.25 |
Projected Price Trends
- Continued generic competition is expected to reduce prices by an average of 3% annually over the next five years.
- Patent expirations of key formulations have facilitated price erosion.
- Price stabilization is anticipated as supply chain dynamics and demand plateau.
Factors Influencing Future Prices
- Potential shortages due to manufacturing disruptions can temporarily inflate prices.
- Introduction of extended-release or novel delivery systems may command premiums in niche markets.
- Regulatory changes affecting approval pathways could either constrain or bolster pricing strategies.
Future Revenue and Market Penetration Projections
| Year |
Estimated Market Revenue (USD billion) |
Key Assumptions |
| 2023 |
1.2 |
Slight increase post-pandemic recovery |
| 2025 |
1.3 |
Organic growth, stable pricing |
| 2030 |
1.4 |
Market saturation, price erosion slows |
The compound annual growth rate (CAGR) for the segment is forecasted at approximately 2% from 2023 to 2030.
Investment and Development Outlook
- No current major clinical pipeline developments focus solely on this specific formulation.
- Incremental improvements, such as reduced toxicity or extended duration, could rejuvenate market interest.
- Manufacturers investing in biocompatible delivery systems may create pricing power.
Key Takeaways
- Market Size: Approx. USD 1.98 billion in the U.S., with sustained demand driven by procedural growth.
- Pricing: Presently USD 4.75–USD 6.25 per 50 mL vial, trending downward 3% annually due to generic competition.
- Market Dynamics: Saturation with generics, low barriers to entry, and patent expirations drive pricing and supply.
- Future Outlook: Modest growth expected, with stabilization in prices and incremental market expansion.
- Regulatory Landscape: No significant patent protections; regulatory pathways favor generics; supply chain variability impacts prices.
FAQs
Q1: What factors could disrupt the supply of NDC 23155-0287?
Disruptions may occur due to manufacturing plant closures, raw material shortages, or regulatory issues. Such disruptions can cause temporary price spikes.
Q2: How does the competitive landscape influence prices?
High competition among generic manufacturers tends to push prices down, especially as patents expire and market entry barriers decline.
Q3: Are there any upcoming regulatory changes that could impact this drug?
Potential changes include accelerated approval pathways or safety regulations. Currently, no imminent regulatory shifts are expected specifically for this formulation.
Q4: What are the prospects for innovation within this drug segment?
Innovations such as extended-release formulations or combination therapies could create premium segments but face regulatory and development hurdles.
Q5: How does market demand in emerging markets compare to the U.S.?
Emerging markets are experiencing increased procedural volume, but price sensitivity and regulatory variations limit rapid adoption of premium formulations.
Sources
- MarketWatch. "Global Local Anesthetics Market," 2022.
- IQVIA. "US Prescription Trends," 2022.
- FDA. "Drug Approvals and Patent Data," 2023.
- Drugs.com. "Bupivacaine NDA & Pricing Data," 2023.
- Grand View Research. "Anesthetics Market Analysis," 2022.
