Last updated: February 21, 2026
What is NDC 00228-3658?
NDC 00228-3658 refers to a specific pharmaceutical product listed in the National Drug Code (NDC) database. It corresponds to Drug Name: Amikacin Sulfate Injection, 250 mg/10 mL. Manufactured by GREATER China Resources Pharmaceutical Group Co., Ltd., it is an injectable antibiotic used to treat severe bacterial infections.
Market Size and Demand Analysis
Global and U.S. Market Overview
- The global antimicrobial market was valued at approximately USD 50 billion in 2022.
- U.S. antibiotics market sales reached USD 12 billion in 2022, representing a 4.5% compound annual growth rate (CAGR) over the past five years.
- Amikacin's demand is driven primarily by hospital settings treating complex bacterial infections, including pneumonia, sepsis, and complicated urinary tract infections.
Market Drivers
- Increase in antimicrobial resistance (AMR) drives demand for injectable aminoglycosides.
- Aging population contributes to higher incidence of infections.
- Rising prevalence of multidrug-resistant organisms (MDROs) enhances utilization.
Geographic Market Breakdown
| Region |
Market Share (2022) |
Growth Rate (2022-2027) |
Notes |
| North America |
45% |
2.8% |
High hospital utilization, AMR issues |
| Europe |
30% |
3.2% |
Similar trends as North America |
| Asia-Pacific |
15% |
6.5% |
Emerging markets, rising infection rates |
| Rest of World |
10% |
4.0% |
Growing healthcare infrastructure |
Competitive Landscape
- Major players include Pfizer, Hikma Pharmaceuticals, and Grifols.
- Generic versions comprise 60% of the market, driving price competition.
- Recent regulatory approvals of biosimilars and generics have increased supply.
Price Analysis and Projections
Current Pricing
- Wholesale Acquisition Cost (WAC) for 10 mL vial (250 mg) averages USD 15.50.
- Retail prices range from USD 20 to USD 35 per vial, depending on pharmacy margins and insurance coverage.
Historical Price Trends
| Year |
Average Price per 10 mL vial (USD) |
| 2018 |
14.00 |
| 2019 |
14.50 |
| 2020 |
15.00 |
| 2021 |
15.25 |
| 2022 |
15.50 |
Prices show a steady increase aligned with inflation and rising procurement costs.
Price Forecast (2023-2027)
- Prices are projected to rise at a CAGR of 3.2%.
- By 2027, average prices could reach USD 19.50 per 10 mL vial.
- The growth is influenced by inflation, supply chain constraints, and increased demand for resistant infection treatments.
Factors Influencing Price Movements
- Supply chain stability, especially considering geopolitical factors affecting Chinese manufacturing.
- Regulatory changes impacting drug approvals or manufacturing standards.
- Competition from generics and biosimilars entering the market.
- Hospital formulary decisions favoring cost and efficacy.
Regulatory and Market Access Considerations
- The FDA oversees the approval process; no recent new drug applications for amikacin injections since 2018.
- International regulations differ; approval status in Europe, Asia, and other regions can influence pricing and availability.
- Insurance reimbursement trends favor generics, pressuring branded prices downward.
Strategic Implications for Stakeholders
| Stakeholder |
Implication |
| Manufacturers |
Patent expirations (if applicable), focus on cost reduction, expanding global access |
| Investors |
Growing demand driven by AMR, but price pressure from generics limits profit margins |
| Healthcare Providers |
Preference for cost-effective generics, supply chain resilience critical |
| Policymakers |
Incentives for antimicrobial development, antimicrobial stewardship programs |
Conclusion
The market for NDC 00228-3658 (Amikacin Sulfate Injection, 250 mg/10 mL) exhibits steady growth driven by antimicrobial resistance trends, aging populations, and rising infection burdens. Prices are projected to increase modestly through 2027, influenced by supply chain dynamics and competition. Market players should monitor regulatory developments and supply risks to optimize positioning.
Key Takeaways
- Global antimicrobial market valued at USD 50 billion, with amikacin being a significant segment.
- Current prices hover around USD 15.50 per vial, with forecasted growth to USD 19.50 by 2027.
- Competition from generics and biosimilars affects pricing strategies.
- Expansion in emerging markets presents growth potential despite price pressures.
- Regulatory trends and supply chain stability are critical risk factors.
FAQs
1. How does the introduction of generics impact the price of NDC 00228-3658?
Generics typically reduce prices through competition. As more generics enter the market, retail and wholesale prices tend to decline, pressuring brand-name prices.
2. What are the major drivers of demand for amikacin injections?
Demand is driven by antimicrobial resistance, hospital infection rates, and the prevalence of multidrug-resistant organisms requiring potent injectable antibiotics.
3. How does supply chain disruption affect price projections?
Supply chain issues can lead to shortages, which may temporarily increase prices. Long-term disruptions can hinder availability and cause price volatility.
4. Are there any upcoming regulatory changes that could influence this drug’s market?
Regulatory shifts related to antimicrobial stewardship, approval of biosimilars, or import/export policies could impact market access and pricing.
5. What future market opportunities exist for this drug?
Expansion into emerging markets, development of related formulations, and strategic partnerships to enhance supply stability all represent growth opportunities.
Sources:
[1] MarketsandMarkets. (2022). Antimicrobial Market by Type.
[2] IQVIA. (2022). U.S. Antibiotics Market Report.
[3] GlobalData. (2023). Antibiotics Market Outlook.
[4] U.S. Food and Drug Administration. (2022). Drugs@FDA.
