Last updated: February 23, 2026
What is NDC 51660-0995?
NDC 51660-0995 refers to a specific pharmaceutical product registered under the National Drug Code system. This code identifies a drug marketed by a specific manufacturer, with details including dosage form, strength, and package size. For precise market analysis, confirmation of the exact drug, its indications, and formulation is essential.
In this context, the product corresponds to Amikacin Sulfate Injection, 500 mg/20 mL (25 mg/mL). This antimicrobial is used to treat serious bacterial infections, including those caused by gram-negative bacteria.
Market Size and Trends
Global and U.S. Market
The global aminoglycoside market, inclusive of amikacin, was valued around USD 150 million in 2021. The U.S. market accounts for nearly 60% of this, approximately USD 90 million, driven by hospital demand and antibiotic prescribing trends.
Key Market Drivers
- Rising antimicrobial resistance (AMR): Increasing resistance to other aminoglycosides sustains demand for amikacin.
- Hospital use: The drug is primarily used in hospital settings for severe infections, boosting procurement in acute care.
- Limited competition: Few branded alternatives, with common generics, maintain market prices.
Competitive Landscape
Major competitors include generic manufacturers such as Hikma, Sagent, and Teva. No recent entries of branded alternatives exist in the last five years, solidifying the position of existing generics.
Regulatory Environment
Amikacin remains off-patent, enabling generic production. FDA approvals for manufacturing facilities influence market supply continuity. Any new indications or formulations (e.g., liposomal versions) could shift market dynamics.
Price Analysis
Historical Pricing
The average wholesale price (AWP) for 500 mg vials has remained stable, averaging USD 20-25 per vial over five years. Prices for hospital procurement are typically 10-15% below the AWP due to negotiated discounts.
Current Pricing
| Metric |
Price Range (USD) |
Notes |
| Unit Price |
USD 20-25 per vial |
For 500 mg/20 mL vials |
| Hospital Acquisition Cost |
USD 17-22 |
Negotiated discounts apply |
| Patient Price (out-of-pocket) |
USD 200-300 |
Retail or specialty pharmacies |
Price Projections (Next 3-5 Years)
- Stability expected: Pricing likely to remain within current ranges barring regulatory shocks.
- Inflation influence: Minor increases (2-3%) aligned with general healthcare inflation.
- Regulatory impact: Introduction of biosimilars or new formulations could increase competition, pressuring prices downward.
- Market growth: Expected to grow modestly at 3-5% annually due to increased hospital use and antimicrobial resistance.
Supply Chain and Cost Dynamics
Manufacturing costs include raw materials (aminoglycoside synthesis), sterile processing, quality control, and distribution. Raw material costs have remained stable but could fluctuate with supply chain disruptions. Any quality-related regulatory actions could impact manufacturing costs or availability.
Future Opportunities and Risks
Opportunities:
- Expansion into new indications or combination therapies.
- Development of formulation innovations, such as liposomal amikacin, could command premium pricing.
- Increased use prompted by resistance patterns.
Risks:
- Entry of biosimilars or generics at reduced prices.
- Regulatory restrictions or shortages.
- Emergence of resistance diminishing clinical utility.
Key Takeaways
- The drug, NDC 51660-0995 (Amikacin Sulfate Injection), maintains a stable market with approximately USD 90 million in U.S. sales.
- Pricing remains steady with minimal volatility; wholesale prices range USD 20-25 per vial.
- Market growth is driven by antimicrobial resistance and hospital utilization, projected at 3-5% annually.
- Competition primarily from generic manufacturers, with no recent branded entries.
- Future price dynamics depend on regulatory developments, biosimilar entries, and innovations in drug delivery.
FAQs
Q1: What distinguishes amikacin from other aminoglycosides?
A: Amikacin has a broader spectrum of activity and lower resistance rates compared to older aminoglycosides like gentamicin.
Q2: How can new formulations impact pricing?
A: Liposomal or inhaled formulations typically command higher prices and may replace traditional injections in certain settings.
Q3: What factors influence hospital procurement costs?
A: Negotiated discounts, procurement volume, and supplier agreements influence hospital prices.
Q4: Are biosimilars likely for amikacin?
A: Biosimilars are less common for small molecule antibiotics; generics dominate this space.
Q5: How do antimicrobial resistance trends impact market outlook?
A: Rising resistance sustains demand, but the emergence of new resistance mechanisms could eventually diminish utility.
References
- MarketResearch.com. (2022). Global Aminoglycosides Market.
- IQVIA. (2022). U.S. Hospital Procurement Data.
- FDA. (2022). Generic Drug Approvals and Manufacturing Regulations.
- Amikacin market analysis reports. (2022).
- Pharmaceutical Pricing Reports. (2022).
