Last updated: April 1, 2026
What is NDC 54092-0513?
National Drug Code (NDC) 54092-0513 is identified as Bupivacaine Hydrochloride Injection, 0.75%. It is a locally administered anesthetic used in procedures requiring regional anesthesia, including epidural, spinal, or peripheral nerve blocks.
Market Size and Demand Dynamics
Current Market Volume
The U.S. market for local anesthetics, including bupivacaine, estimated at approximately $390 million in 2022, is expected to grow at a CAGR of 4% over the next five years. Bupivacaine represents roughly 70% of this segment, translating to a market value of ~$273 million (source: IQVIA, 2022).
Key Market Drivers
- Elective Surgical Procedures: Recovery from COVID-19 has increased elective surgeries, boosting demand.
- Anesthesia Practice Patterns: Shift toward regional anesthesia techniques favor Bupivacaine use.
- Competitive Landscape: Dominated by Pfizer’s Marcaine, with generic versions gaining market share.
Competitive Position
Generic Bupivacaine formulations, including NDC 54092-0513, account for approximately 60-70% of sales, driven by cost sensitivity and increased institutional adoption. Patent expirations in the late 2010s facilitated generic entry, leading to price declines.
Pricing Analysis
Current Price Points
Wholesale acquisition cost (WAC) for 100 mL of 0.75% Bupivacaine HCl Injection is approximately $28–$35. Institutional procurement prices are typically 10–20% lower.
Historical Price Trends
- 2015: WAC around $25 for similar volume.
- 2020: Increased to about $32–$35 amid manufacturing supply chain adjustments.
- 2023: Prices stabilized; however, with the entrance of biosimilar competition, further declines are expected.
Price Projections (2023–2028)
| Year |
Estimated WAC per 100 mL |
Notes |
| 2023 |
$30–$35 |
Price stabilization; biosimilar entry pressures |
| 2024 |
$28–$34 |
Increased generic penetration |
| 2025 |
$27–$32 |
Further margin compression |
| 2026 |
$25–$30 |
Market saturation; generic prevalence |
| 2027 |
$24–$28 |
Slight price decline expected |
Factors Influencing Price Trajectory
- Regulatory Approvals: Pending biosimilar approvals can intensify price competition.
- Manufacturing Costs: Stable, with minor volatility due to raw material sourcing.
- Market Adoption: Shift toward biosimilars and cheaper formulations reduces average selling prices.
- Supply Chain Disruptions: Potentially push prices upward temporarily, but long-term trends remain downward.
Regulatory Environment Impact
- FDA Approvals: The FDA has approved multiple generic versions; biosimilars are in development stages.
- Pricing Policies: Value-based pricing models in hospitals and clinics influence negotiated transaction costs.
- Reimbursement Trends: CMS adjustments favoring cost containment pressure prices downward.
Investment and R&D Outlook
- Companies investing in biosimilar development may pressure existing prices.
- Patent cliffs in the next 2–3 years create opportunities for new entrants.
- R&D focus on formulations that offer longer duration or reduced toxicity remains active.
Key Takeaways
- The current NDC 54092-0513 (Bupivacaine Hydrochloride Injection, 0.75%) has a stable market with a CAGR of approximately 4%.
- Prices are trending downward due to an increase in generic and biosimilar competition.
- Market demand is driven by elective surgeries, regional anesthesia practices, and hospital procurement policies.
- Price projections indicate a decline to approximately $24–$28 per 100 mL by 2027, with continued downward pressure from generics.
- Regulatory and supply chain factors will significantly influence future market dynamics.
FAQs
What is the main driver of price reductions for this drug?
The main driver is increased competition from generic and biosimilar versions, leading to reduced listing prices and negotiated rates.
How does market demand influence future prices?
Growing demand from elective surgeries sustains revenues but does not significantly alter price trends due to competitive pressures.
Are biosimilars a future threat to this drug’s market?
Yes. Biosimilars for local anesthetics like bupivacaine are in development and could further reduce prices upon approval.
What are potential risks to price stabilization?
Regulatory delays, manufacturing shortages, or supply chain disruptions could temporarily increase prices; however, long-term trends favor decline.
How do policy changes affect price projections?
Reimbursement policies aimed at cost controls favor lower transaction prices; legislative shifts could accelerate or decelerate price declines.
References
[1] IQVIA. (2022). US Market Trends for Local Anesthetics.
[2] U.S. Food and Drug Administration. (2022). Bupivacaine FDA Approvals and Notices.
[3] MarketWatch. (2023). Local Anesthetics Market Analysis Report.
[4] Xanodyne Pharmaceuticals. (2017). Patent and Market Data on Bupivacaine.
[5] Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement Policy Updates.
