Last updated: February 25, 2026
What is the drug associated with NDC 00456-2405?
The drug corresponding to NDC 00456-2405 is Bupivacaine Hydrochloride Injectable Solution. It is a local anesthetic used primarily for surgical procedures, epidural anesthesia, and pain management. The product is marketed by Hospira, a division of Pfizer, with formulations typically in 0.75% and 0.25% concentrations.
How is the market size shaping for Bupivacaine?
Current Market Data
- The global local anesthetic market was valued at approximately USD 2.86 billion in 2021.
- CAGR estimated at 6.1% from 2022 to 2030.
- North America accounts for roughly 40% of the market, driven by high surgical volumes and aging population.
- Key competitors include marketed brands such as marcaine (marketed by subsidiaries of Pfizer), lidocaine, mepivacaine, and ropivacaine.
Market Drivers
- Rising incidence of chronic pain conditions.
- Growing number of outpatient procedures requiring local anesthesia.
- Increased use in obstetric and surgical settings.
- Expanding healthcare infrastructure in emerging markets.
Market Constraints
- Stringent regulatory standards.
- Price pressures due to generic competition.
- Supply chain disruptions affecting raw material costs.
Pricing Analysis
Current Price Range
- Average wholesale price (AWP) for Hospira's Bupivacaine 0.5% injectable vial (50 mL) is approximately USD 30–40 per vial.
- Generic equivalents price at USD 15–25 per vial.
- Variability exists based on volume, setting, and purchaser type (hospital vs. pharmacy).
Pricing Trends
- Prices have remained relatively stable over the past 3 years.
- Slight downward pressure from increased competition and generics.
- Expiry of patent exclusivity expected to accelerate generic entry, continuing price erosion.
Cost Analysis
- Raw material costs account for roughly 20–30% of the retail price.
- Manufacturing expenses are relatively stable but may increase due to supply chain factors.
Competitive Landscape
| Product Name |
Manufacturer |
Formulation |
Market Share (Est.) |
Price Range (USD) |
Patent Status |
| Marcaine |
Pfizer |
0.5%, 0.75% |
55% |
30–40 per vial |
Patent expired (2005) |
| Sensorcaine |
AstraZeneca |
0.5%, 0.75% |
25% |
20–30 per vial |
Patent expired |
| Bupivacaine (generic) |
Multiple |
0.5%, 0.75% |
20% |
15–25 per vial |
No patent |
Price Projection Outlook (2023–2027)
| Year |
Estimated Average Price (USD per vial) |
Key Factors Influencing Price |
| 2023 |
15–25 |
Increased generics entry, supply chain normalization |
| 2024 |
14–23 |
Additional patent expirations, market saturation |
| 2025 |
12–20 |
Supply chain improvements, price competition intensifies |
| 2026 |
11–18 |
Further generics, price stabilization expected |
| 2027 |
10–17 |
Market maturity, further cost reductions |
Assumptions
- Patent expirations of branded formulations occur as scheduled, enabling generics.
- Healthcare cost containment policies tighten, exerting downward pricing pressure.
- Production costs remain stable, but raw material inflation may marginally affect prices.
- Adoption rates stabilize post-pandemic, with no major regulatory shifts.
Risks and Opportunities
Risks
- Price erosion due to unregulated entry of generics.
- Supply chain disruptions increasing costs.
- Regulatory delays on new formulations or biosimilars.
Opportunities
- Developing extended-release formulations to command premium pricing.
- Expanding into emerging markets with increasing healthcare access.
- Partnering with distributors to optimize supply chain and pricing strategies.
Key Takeaways
- The NDC 00456-2405 market, representing bupivacaine injectable solutions, is mature, with stable pricing and high competition.
- Generics dominate the market, exerting downward price pressure.
- Prices are projected to decline modestly over the next five years, with a median AVP of USD 12–20 per vial by 2027.
- Market growth continues driven by procedural volume increases, though growth rates are moderated by pricing pressures.
- Strategic focus on evolving formulations, emerging markets, and supply chain efficiencies can mitigate risks and unlock new revenue streams.
FAQs
1. When do patent expirations for branded bupivacaine formulations occur?
Most patents expired around 2005–2010, opening the market to generics.
2. How much does a vial of bupivacaine cost today?
Average wholesale prices range from USD 15 to 40, depending on the manufacturer and formulation.
3. Are there notable regulatory hurdles for expanding generic options?
Yes. Regulatory agencies require demonstration of bioequivalence, stability, and manufacturing quality, which can delay new generic entry.
4. What are emerging markets' opportunities in this space?
Increasing healthcare infrastructure investments and rising procedure volumes in Asia, Africa, and Latin America present growth avenues.
5. How can manufacturers influence future pricing?
Through formulation innovation, bulk purchasing agreements, and optimizing supply chains to reduce costs.
References
[1] Grand View Research. (2022). Local Anesthetics Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). US Prescription Drug Market Data.
[3] Statista. (2022). Global Market Revenue for Local Anesthetics.
[4] U.S. Food and Drug Administration. (2020). Patent and Exclusivity Data.
[5] MarketWatch. (2022). Price Trends in Injectable Local Anesthetics.
