Last updated: March 2, 2026
What is NDC 00037-8130?
NDC 00037-8130 is a drug marketed as Bupivacaine Hydrochloride Injectable. It is a local anesthetic used for regional anesthesia, nerve blocks, and epidural anesthesia. The drug is supplied in multiple formulations, typically in 50 mg/50 mL (1 mg/mL) vials or syringes.
Market Size and Dynamics
Market Segment
- Indications: Pain management during surgical procedures, labor, and postoperative pain.
- Administration Settings: Hospitals, outpatient surgical centers, anesthesia clinics.
- Prescriber Base: Anesthesiologists, surgeons, pain management specialists.
Market Size Estimates
The global local anesthetics market was valued at approximately USD 2.5 billion in 2021. Bupivacaine specifically accounts for roughly 30% of this market, translating to an estimated USD 750 million globally in 2021.
Key Market Players
- MediRx (originator brand: Marcaine by AstraZeneca)
- Hospira (Pfizer) (generic version)
- Hikma Pharmaceuticals
- Sagent Pharmaceuticals
- Sun Pharmaceutical Industries
Supply Chain Considerations
- Manufacturing is concentrated among a handful of API producers, with quality and compliance importance affecting market access.
- Distribution channels include direct hospital supply agreements, group purchasing organizations (GPOs), and wholesale suppliers.
Regulatory Environment
- FDA approval facilitates US market access.
- Patent expiry for original brands typically in the late 2010s, increasing generic competition.
- Price controls are limited in the US but more prominent in European markets.
Price Analysis
Historical Pricing Data
| Formulation |
Average Price (USD) |
Market Entry Year |
Notes |
| 50 mg/50 mL vial |
$10 - $15 |
2018 |
Competitive generic pricing |
| Single-use pre-filled syringe |
$20 - $30 |
2019 |
Higher due to convenience |
Price Trends 2018-2022
- Prices for generic Bupivacaine have remained relatively stable, with slight decreases over time following patent expirations and increased competition.
- Hospital procurement prices tend to be discounted, ranging between $8 and $12 per vial.
- The cost of branded formulations remains higher, often exceeding $20 per vial, but market share is declining.
Projections for 2023-2027
- Continued price stabilizations with a potential slight decrease (~2-3% annually) driven by further generic market proliferation.
- Price pressures accentuated by regional price controls and procurement policies in jurisdictions outside the US.
- Anticipated entry of biosimilar or alternative local anesthetic formulations could further reduce prices by up to 10%.
Cost Factors Influencing Price
- API manufacturing costs (~USD 1 - 2 per gram, with margin)
- Regulatory and quality compliance expenditures
- Packaging and distribution logistics
- Market competition and volume purchasing power
Market Trends and Drivers
Increased Adoption
- Growing outpatient procedures increase demand for cost-effective local anesthetics.
- Expanding use in pain management protocols for chronic conditions.
Competitive Landscape
- Conversion from branded to generic formulations reduces prices.
- Introduction of new delivery systems, such as pre-filled syringes, improves convenience but at slightly higher cost.
Geographic Variations
| Region |
Price Range ($) |
Market Penetration |
Regulatory Barriers |
| United States |
$8 - $15 |
High |
Moderate |
| European Union |
€7 - €13 |
Moderate |
Stringent approval processes |
| Asia-Pacific |
$5 - $10 |
Growing |
Varying regulatory standards |
Strategic Considerations
- For manufacturers: Focus on API cost optimization to sustain margins.
- For buyers (hospitals, clinics): Leverage bulk purchasing to negotiate better prices.
- For investors: Opportunities exist in mid-tier producers offering cost-competitive formulations.
Key Takeaways
- NDC 00037-8130 (Bupivacaine Hydrochloride) belongs to a mature market facing significant generic competition.
- Pricing remains stable with slight downward trends over recent years, driven by market saturation.
- The global market is projected to grow modestly at around 3-4% annually, aligning with increasing procedural volumes.
- Market entry barriers are moderate; manufacturing costs are low, but brand competition influences prices.
- Regional policies can significantly impact pricing and market access.
FAQs
-
How does patent status affect prices for NDC 00037-8130?
Patent expiration led to generic competition, reducing prices. No active patents for the original formulation limit exclusive pricing.
-
What are the primary factors influencing price differences between regions?
Regulatory standards, procurement practices, and market competition drive regional price variances.
-
Are biosimilars or alternative drugs available for NDC 00037-8130?
No; biosimilars are not applicable to small-molecule anesthetics like Bupivacaine. Alternatives include other local anesthetics with different efficacy profiles and costs.
-
What key trends could impact future prices?
Increased use of cost-effective generics, regional price controls, and technological advances in delivery systems.
-
What is the outlook for NDC 00037-8130 in the next five years?
Prices are expected to decline slightly, with growth driven by procedural volume increases and new formulations that improve usability.
References
[1] MarketsandMarkets. (2022). Local Anesthetics Market by Type, Application, End User, and Region - Global Forecast to 2027.
[2] IQVIA. (2021). Global Market Reports on Anesthetics.
[3] U.S. Food and Drug Administration. (2022). Drug Approvals and Labeling.
