Last updated: February 24, 2026
What Is NDC 70000-0636?
NDC 70000-0636 refers to a drug product registered with the National Drug Code. According to available data, NDC 70000-0636 is identified as Bupivacaine HCl Injection, 0.75%. It is indicated for local anesthesia in surgical procedures. The manufacturer associated with this NDC is Hospira Inc., now part of Pfizer.
Market Size and Demand
Current Market Overview
- Global Local Anesthesia Market: Valued at approximately USD 3.8 billion in 2022; projected to grow at a CAGR of 5.4% through 2027 (Research and Markets, 2022).
- US Market Share: Accounts for roughly 35% of the global market, approximately USD 1.33 billion.
- Top Segments: Bupivacaine injections hold nearly 25% of the local anesthesia market, driven by surgical volume, anesthesia protocols, and hospital procurement.
Demand Drivers
- Increased surgical procedures: US hospital surgeries increased by 3.2% annually over the past five years.
- Expansion of outpatient procedures: outpatient surgeries now represent over 60% of all surgical interventions.
- Aging population: elevates demand for anesthesia agents, including Bupivacaine.
Competitive Landscape
- Main competitors include Marcaine (AstraZeneca), Sensorcaine (Hospira/Pfizer), Aparan, and generic equivalents.
- Patent status: Bupivacaine HCl Injection held patents until 2021, with generic versions entering the market since then.
Price Analysis
Historical Pricing Patterns
- Brand Name (Marcaine): Historically sold at approximately USD 15–20 per vial (20 mL).
- Generics: Currently retail at USD 10–13 per vial depending on supplier and purchase volume.
- Market Trend: Prices have decreased steadily from pre-2021 levels due to patent expirations and increased generic competition.
Current Pricing Data (as of Q1 2023)
| Product Type |
Price per 20 mL vial |
Market share |
| Brand Name (Marcaine) |
USD 18 |
55% |
| Generic |
USD 11 |
45% |
Volume and Revenue Projections
- Annual US volume: Estimated at 10 million vials, based on surgical procedure data.
- Projected revenue: USD 110 million annually under current pricing and volume assumptions.
- Growth prospects: If surgical volume increases at 3% annually, revenue could reach USD 130 million by 2025.
Price Projection (2023–2027)
Considering patent expirations, market competition, and inflation:
| Year |
Estimated Price per 20 mL vial |
Assumptions |
| 2023 |
USD 11.50 |
Slight price erosion due to increased generics |
| 2024 |
USD 11.20 |
Market stabilization; slight discounts for bulk buying |
| 2025 |
USD 11.00 |
Generic market saturation; possible minor price reductions |
| 2026 |
USD 10.80 |
Further competition; potential for price reductions |
| 2027 |
USD 10.50 |
Stabilized at competitive levels |
This projection reflects a gradual decline of approximately 0.4% annually, aligned with market trends and increased competition.
Policy and Regulatory Factors
- FDA Approvals: The product remains FDA-approved; no recent label modifications reported.
- Patent Status: Patent expiration in 2021 facilitates generic entry.
- Pricing regulations: Limited direct regulation in the US, but state Medicaid programs and PBMs influence reimbursement rates.
Strategic Implications
- Manufacturers: Focus on cost-efficient production and establishing preferred provider agreements to maintain margins.
- Investors: Expect downward pricing trends but stable demand driven by surgical volume growth.
- Distributors: Should monitor inventory levels to capitalize on sustained demand and price stability.
Summary
NDC 70000-0636, representing Bupivacaine HCl Injection, faces price erosion driven by generic competition. Market demand remains robust due to surgical volume and demographic factors. Prices are projected to decline modestly through 2027, stabilizing around USD 10.50 per 20 mL vial. Revenue prospects depend on market penetration, procurement strategies, and volume growth.
Key Takeaways
- The market for Bupivacaine HCl Injection remains sizable with stable demand.
- Prices have decreased significantly since patent expiry, with continued modest declines projected.
- Competition from generics has increased supply and lowered prices.
- Volume growth driven by surgical and demographic trends mitigates revenue decline.
- Stakeholder strategies should prioritize cost management, supply chain agility, and competitive pricing.
FAQs
1. What factors influence the price of NDC 70000-0636?
Patents, generic competition, manufacturing costs, procurement policies, and demand levels directly influence pricing.
2. How does the entry of generics impact market dynamics?
Generics increase market competition, reduce prices, and shift market share from branded products.
3. What are the key considerations for purchasing agencies?
Price stability, supplier reliability, and procurement volume discounts are critical factors.
4. Is the market for Bupivacaine HCl injection likely to expand?
Yes, driven by increasing surgical procedures and outpatient surgeries, though price pressure persists.
5. How might regulatory changes affect future pricing?
Stricter pricing regulations or policy reforms in healthcare could influence reimbursement rates and profit margins.
References
- Research and Markets. (2022). Global Local Anesthesia Market Report 2022 - 2027.
- IQVIA. (2022). US Surgical Procedure Volume Data.
- FDA. (2022). Orange Book: Drug Patent Expirations and Approvals.
- Medicaid and PBM policies influence. (2023). State-level reimbursement policies.
