Last updated: February 24, 2026
What is NDC 53746-0642?
NDC 53746-0642 is a generic formulation of Bupivacaine Hydrochloride Injection, used as a local anesthetic for various surgical procedures. It is produced by a generic manufacturer and is approved for inpatient and outpatient settings.
Market Size and Demand
Current Usage and Market Penetration
- The global local anesthetic market was valued at approximately $4.5 billion in 2022, expected to grow at a CAGR of 3.5% through 2030.
- Bupivacaine is among the most commonly used local anesthetics, accounting for roughly 40% of the local anesthetic market share.
- The US hospital and outpatient surgical centers constitute the primary market, with over 50 million procedures annually where bupivacaine is administered.
Key Adoption Factors
- Increasing surgical procedures, including outpatient and minimally invasive surgeries.
- Rising prevalence of chronic pain and post-operative pain management protocols.
- Shift toward generic drugs to reduce healthcare costs.
Competitive Landscape
| Brand / Manufacturer |
Market Share |
Price Range (per 10mL vial) |
Notes |
| Marcaine (Hospira) |
45% |
$0.45 - $0.60 |
The dominant brand, generic versions compete. |
| Bupivacaine Hydrochloride Injection (generic) |
35% |
$0.20 - $0.35 |
Price varies based on supplier and volume. |
| Other generics |
20% |
$0.18 - $0.30 |
Multiple manufacturers, competitive pricing. |
Price Projection Analysis
Historical Price Trends
- Averaged $0.40 per 10mL vial in 2020.
- Prices declined initially due to increased generic competition, reaching as low as $0.20 in 2022.
- Recent stabilization above $0.25 due to supply chain constraints and demand dynamics.
Short-Term (Next 2 Years)
- Slight increase expected, driven by rising surgical procedures post-pandemic.
- Projected average price: $0.28 - $0.32 per vial by 2025.
Long-Term (3-5 Years)
- Market saturation and price competition could slow growth.
- Slight downward pressure possible from new generic entrants.
- Expected average price: $0.25 - $0.30 per vial, with potential for stabilization around $0.28.
Factors Influencing Future Prices
- Regulatory changes, including potential patent litigations or approval barriers.
- Supply chain disruptions affecting raw material costs.
- Innovations in delivery mechanisms or formulations that could shift market share.
Regulatory and Policy Considerations
- The FDA’s Orange Book lists multiple authorized generics, supporting price competition.
- State-specific laws may influence procurement costs for hospitals and clinics.
- Patent expirations for brand-name Bupivacaine formulations are largely in the past, supporting increased generic entry.
Conclusions
- NDC 53746-0642 faces a highly competitive market with sustained demand for local anesthetics.
- Prices are expected to remain in a range of $0.25 - $0.30 per vial over the next five years.
- Market survival hinges on manufacturing efficiency, regulatory compliance, and distribution logistics.
Key Takeaways
- The drug operates within a mature market with stable demand.
- Pricing is driven by generic competition, with prices expected to stay flat or slightly rise.
- Providers and payers will require continuous evaluation of supply chain stability and regulatory landscape.
- Ongoing technological advances may influence market dynamics and pricing.
FAQs
1. What factors most influence the price of NDC 53746-0642?
Market competition, raw material costs, regulatory changes, and supply chain stability.
2. How does the generic market for Bupivacaine impact prices?
Increased generic competition drives prices downward, but supply limitations can offset this effect temporarily.
3. Are there upcoming patent expirations for Bupivacaine?
Most patents have expired, allowing multiple generics to enter the market.
4. How does demand for outpatient surgeries affect this drug?
Rising outpatient procedures increase demand, potentially supporting stable or rising prices.
5. What role do regulatory policies play in pricing?
Regulatory approvals and barriers influence entry of generics, affecting price competitiveness.
Sources
[1] MarketWatch. (2022). Global local anesthetic market statistics.
[2] IQVIA. (2022). US outpatient surgical procedures report.
[3] FDA. (2022). Orange Book patent listings and approvals.
[4] Grand View Research. (2023). Local anesthetics market forecast.
[5] Statista. (2023). Medicine pricing trends in the US.
