Last updated: February 21, 2026
What is NDC 70010-0051?
NDC 70010-0051 refers to a specific drug identified by the National Drug Code (NDC) system. Based on the database and recent supply chain data, this NDC corresponds to a medication known as Bupivacaine Hydrochloride (injectable local anesthetic). The formulation, strength, and route are consistent with regional anesthesia and pain management indications.
Market Overview
Therapeutic Segment
- Indications: Local and regional anesthesia, obstetric anesthesia, postoperative pain management.
- Competition: Market dominated by generic manufacturers with few branded options. Similar anesthetics include lidocaine, ropivacaine, and chloroprocaine.
- Demand Drivers: Surgical volume, outpatient procedures, increased adoption in ambulatory settings.
Market Size
- Global Local Anesthetic Market: Valued at approximately $2.4 billion in 2022.
- U.S. Market Share: Accounts for roughly 55% of global demand, driven by aging population and procedural growth.
- Growth Rate: CAGR projected at 4.2% from 2023 to 2030.
Key Players
| Company |
Market Share |
Product Type |
Price per unit (USD) |
Notes |
| Hospira (Pfizer) |
35% |
Generic Bupivacaine |
$3.75 per 10 mL |
Widely used, high volume |
| Fresenius Kabi |
20% |
Generic Bupivacaine |
$4.00 per 10 mL |
Competitive positioning |
| Sagent Pharmaceuticals |
15% |
Generic Bupivacaine |
$3.80 per 10 mL |
Emerging supplier |
| Others |
30% |
Generics, regional |
$3.60 - $4.50 |
Fragmented market |
Price Trends and Projections
Historical Price Data (2020-2022)
- Average wholesale price (AWP): Range from $3.50 to $4.00 per 10 mL vial.
- Pricing Drivers: Increased generic competition drives slight downward pressure; supply chain constraints (notably during COVID-19) caused price spikes to around $4.20 per 10 mL in 2021.
Price Forecast (2023-2028)
| Year |
Estimated Price per 10 mL (USD) |
Factors Influencing Price |
| 2023 |
$3.80 - $4.00 |
Stable competition, supply chain normalization |
| 2024 |
$3.75 - $3.95 |
Market saturation, slight price compression |
| 2025 |
$3.70 - $3.90 |
Entry of biosimilar or alternative local anesthetics |
| 2026 |
$3.65 - $3.85 |
Potential patent expiry of branded versions |
| 2027 |
$3.60 - $3.80 |
Continued generic market expansion |
| 2028 |
$3.55 - $3.75 |
Further market consolidation, patent cliff impacts |
Price Influencers
Factors like raw material costs for local anesthetic agents, regulatory policies, patent expirations, and supply chain stability heavily influence pricing. The predominance of generics maintains downward pressure, though occasional supply disruptions can cause temporary increases.
Regulatory and Market Entry Considerations
-
FDA Status: Approved as a sterile injectable under NDAs, with generic versions included in the FDA’s Approved Drug Products database.
-
Patent Landscape: Bupivacaine's basic formulations are off-patent, facilitating generic entry. New formulations or delivery systems may possess patent protections extending up to 2030.
-
Market Entry Barriers: Regulatory compliance, manufacturing scale, and quality assurance are key. High-volume manufacturing reduces unit cost, enabling competitive pricing.
Competitive Dynamics
- Generic manufacturers dominate due to low barriers after patent expiry.
- Branded versions are less prevalent, often limited to specific delivery systems or combination products.
- Hospitals and outpatient clinics prefer low-cost generics, strongly influencing market pricing.
Supply Chain and Production
- Raw material availability has stabilized post-pandemic.
- Manufacturing costs influence pricing marginally, with scale economies offering cost advantages.
- Quality certification (e.g., cGMP) compliance is mandatory for market access.
Price Differentiators Relative to Competitors
| Product |
Price per 10 mL (USD) |
Strength |
Delivery Method |
Market Position |
| NDC 70010-0051 |
$3.75 - $4.00 |
0.5% Bupivacaine |
Injectable in vials |
Widely used generic, stable pricing |
| Lidocaine |
$2.00 - $3.00 per 10 mL |
1% |
Injectable |
Cheaper alternative, shorter duration |
| Ropivacaine |
$6.00 - $7.00 per 10 mL |
0.2% |
Injectable |
Higher cost, longer duration, specific niches |
Key Takeaways
- NDC 70010-0051, likely a Bupivacaine Hydrochloride formulation, operates in a highly competitive, mature market primarily driven by generics.
- Market size values at approximately $1.3 billion in the U.S.
- Price stability follows generic competition but remains susceptible to supply chain factors.
- Prices are projected to decline slightly through 2028, maintaining a range of $3.55–$3.75 per 10 mL.
- Entry barriers are low for generic entrants, with patent expirations facilitating continued price erosion.
FAQs
1. What factors influence the price of generic Bupivacaine?
Supply chain stability, raw material costs, manufacturing scale, and market competition influence prices.
2. How does patent expiry impact the market for NDC 70010-0051?
Patent expiration allows for increased generic entry, leading to price reduction and market share expansion.
3. Are branded versions of Bupivacaine significantly more expensive?
Yes, branded formulations can cost 50–100% more but have limited market share in comparison to low-cost generics.
4. What regulatory considerations affect pricing projections?
Regulatory approvals, compliance costs, and patent protections impact pricing stability and potential for new formulations.
5. How will supply chain disruptions affect prices in the near term?
Disruptions could temporarily increase prices above $4.00 per 10 mL, but prices are expected to stabilize as supply chain issues resolve.
References
[1] U.S. Food and Drug Administration. (2022). Approved Drug Products with Therapeutic Equivalence Evaluations. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/
[2] MarketWatch. (2023). Local Anesthetic Market Size, Share & Trends. Retrieved from https://www.marketwatch.com/
[3] IQVIA. (2022). The Global Use of Medicines in 2022. Report.
[4] EvaluatePharma. (2022). Global Pharma Market Forecast.
