Last updated: February 27, 2026
What is the drug associated with NDC 00093-3560?
The National Drug Code (NDC) 00093-3560 corresponds to Lidocaine Hydrochloride Injectable, 20 mg/mL. It is a local anesthetic used for anesthesia, pain management during procedures, and in emergency settings. The drug is supplied in vials, typically 50 mL or 100 mL, depending on formulations.
Market overview
The global local anesthetic market reached approximately USD 3.4 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of about 4.1% through 2028 [1]. Lidocaine dominates the local anesthetic landscape due to its established safety profile, affordability, and widespread clinical use.
Key market drivers:
- Increasing volume of surgical procedures requiring local anesthesia.
- Rising prevalence of chronic pain disorders.
- Expansion of outpatient and minimally invasive procedures.
- Rising use of lidocaine in emergency and dental settings.
Competitive landscape:
The market features multiple generic manufacturers, with key players including Mylan, Pfizer, Sandoz, and Hikma Pharmaceuticals. Name-brand competitors like AstraZeneca’s Xylocaine face competition mainly from generic versions.
Regulatory status
Lidocaine Hydrochloride injectable formulations are approved across major markets (FDA in the U.S., EMA in Europe, etc.) with generic and branded versions.
In the U.S., the FDA approved the original formulation in the 1950s, with multiple generics approved subsequently. The drug's patent status expired decades ago, leading to a predominantly generic market.
Market share dynamics
In the U.S., the generic segment accounts for over 85% of the injectable lidocaine market. Price competition among generics drives pricing downward, with hospitals, clinics, and pharmacies opting for cost-effective options.
Pricing analysis
Current pricing levels:
| Region |
Average Wholesale Price (AWP) per 50 mL vial |
Market trend |
| United States |
USD 20 - USD 30 |
Stable, slight decrease due to increased generics |
| Europe |
EUR 15 - EUR 25 |
Competitive, varies by country |
| Asia-Pacific |
USD 5 - USD 15 |
Lower prices, growth in local manufacturing |
Price trends:
- US prices for generic lidocaine injectable have decreased approximately 15-20% over the past five years [2].
- Price declines resulted from increased competition and healthcare provider cost pressures.
- Wholesale acquisition costs (WAC) tend to remain 10-15% below AWP.
Price projections (2023-2027):
- Further decline of 2-4% annually in the US market due to marketplace saturation.
- European prices may stabilize with minor fluctuations driven by supply chain factors.
- In emerging markets, prices likely remain stable or decline minimally, contingent on local manufacturing and regulatory policies.
Revenue forecasts
Assuming a stable market share and continued usage, the global market for lidocaine injectables is projected to generate annual revenues of approximately USD 1.2 billion by 2027, primarily driven by North America and Europe, with the Asia-Pacific region capturing increasing market share.
Key factors influencing future pricing and market dynamics:
- Supply chain disruptions: impact on manufacturing costs.
- Regulatory changes: patent expirations and new approvals affecting competition.
- Healthcare policy shifts: emphasis on cost containment.
- Emergence of alternatives: regional local anesthetics and advances in pain management techniques.
Strategic considerations for stakeholders
- Manufacturers should focus on cost efficiencies and expanding access to emerging markets.
- Investors should monitor patent landscapes and new entrants that could alter competitive dynamics.
- Healthcare providers should evaluate the balance between cost and efficacy in procurement decisions.
Summary
The market for NDC 00093-3560 (Lidocaine Hydrochloride Injectable 20 mg/mL) remains mature with high generic penetration. Prices are declining gradually due to increased competition, primarily in North America and Europe. Revenue growth will align with overall demand for anesthesia and Pain-related procedures, with regional disparities influencing price and volume trends.
Key Takeaways
- The injectable lidocaine market is highly saturated with generics, leading to stable yet declining prices.
- Price reductions average around 15-20% over five years in the U.S., with future declines tapering to 2-4% annually.
- Market growth is driven by procedural volume increases, especially in outpatient care and emergency settings.
- Emerging markets present growth opportunities, although pricing remains lower.
- Strategic focus on cost management and supply chain resilience is critical for manufacturers.
FAQs
1. How does patent status influence prices for lidocaine injectable formulations?
Patent expirations decades ago have led to widespread generic availability, significantly reducing prices. Patent expirations facilitate competition, which drives prices downward.
2. What factors could disrupt the current market for lidocaine injectables?
Introduction of new local anesthetic agents, supply chain disruptions (e.g., geopolitical or manufacturing issues), or changes in healthcare purchasing policies could influence market dynamics.
3. How does clinical preference impact lidocaine pricing?
While clinicians prefer lidocaine for its efficacy and safety, the shift toward alternative anesthetics or novel delivery systems could impact demand and pricing.
4. Are there differences in pricing between branded and generic lidocaine?
Yes. Branded formulations typically have higher prices due to branding and patent protection; generics dominate with significantly lower prices.
5. What is the outlook for lidocaine injectable prices in emerging markets?
Prices are generally lower, with slow declines due to local manufacturing, regulatory costs, and market size. Growth in volume may offset slight price declines.
References
[1] Grand View Research. (2022). Local Anesthetic Market Size, Share & Trends Analysis Report.
[2] IQVIA. (2022). Healthcare Cost and Utilization Report.
