Last updated: July 29, 2025
Introduction
The drug identified by NDC 00173-0665 is Cefepime for Injection, USP, a broad-spectrum cephalosporin antibiotic used predominantly in hospital settings to treat severe bacterial infections, such as pneumonia, meningitis, and complicated urinary tract infections. As an essential hospital drug, Cefepime faces a dynamic market influenced by evolving antibiotic resistance patterns, regulatory policies, and competitive landscape shifts. This report provides a comprehensive analysis of the market status and detailed price projection trajectories for Cefepime for Injection, USP, starting with current market insights.
Market Landscape
Current Market Size and Penetration
Cefepime's annual U.S. sales volume hovers around $350-400 million, with a steady growth rate driven by rising infection rates, increasing hospital utilization, and escalating antibiotic resistance. The drug is mainly supplied by major pharmaceutical companies such as Baxter (by means of generic manufacturing) and other generic suppliers. The hospital-based administration model bolsters its revenue stability, though outpatient uses remain minimal.
Key Drivers and Challenges
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Antibiotic Resistance: Increased resistance among Pseudomonas aeruginosa and Enterobacteriaceae strains (ESBL producers) challenges Cefepime’s efficacy. Consequently, hospitals have shifted towards combination therapies or alternative agents in resistant settings, influencing market dynamics.
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Regulatory Environment: The FDA’s approval of generic formulations enhances competition but also prompts policies favoring antimicrobial stewardship programs aimed at optimizing antibiotic use to curb resistance, which might influence demand patterns.
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Emerging Therapies: Novel cephalosporins (e.g., ceftazidime-avibactam) and combination agents are emerging as competitive options, risking market share for Cefepime in specific indications.
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Supply Chain Factors: Generic manufacturers’ capacity and manufacturing quality influence pricing and availability, especially during global crises (e.g., COVID-19, supply chain disruptions).
Competitive Landscape
The marketplace is predominantly composed of generic formulations with multiple producers, resulting in intense price competition. Patent exclusivity is no longer a barrier, emphasizing price as the key differentiator.
Pricing Analysis
Historical Price Trends
Analysis of recent wholesale acquisition costs (WAC), average selling prices (ASP), and hospital procurement data indicates a downward trend over the last five years. For example:
- 2018-2019: WAC averaged approximately $30-35 per vial.
- 2020-2021: Prices decreased to $25-30 per vial due to increased competition.
- 2022-2023: Further reductions, with WACs averaging $20-25 per vial, reflecting commoditization.
Factors Influencing Price Fluctuations
- Entry of generic competitors, as the original patent has expired.
- Increased manufacturing efficiency.
- Bulk purchasing agreements and hospital contract negotiations.
- External pressures from antimicrobial stewardship programs promoting judicious use.
Current Pricing Benchmarks
According to the available data:
- Hospital procurement prices: Ranging from $15 to $22 per 1g vial, depending on volume and contractual agreements.
- Wholesale prices: Approximate $18-24 per vial.
- Patient billing (if applicable): Significantly higher, though often reimbursed by insurance.
Future Price Projections
Projections Methodology
The price projections consider current market saturation, ongoing competition, resistance trends, and regulatory influences. A compound annual decrease (CAD) rate of approximately 5-7% aligns with observed trends and industry forecasts.
Short-term (2024-2026)
- Stable to declining prices, averaging $17-20 per vial by 2026.
- Further commoditization expected, with some stabilization due to manufacturing costs.
Medium to Long-term (2027-2030)
- Potential stabilization of prices, with $15-17 per vial.
- Price decline may plateau due to manufacturing and procurement complexities.
- Emergent resistance or new antibiotic developments could alter this trajectory.
Influence of Emerging Resistance & Policy Changes
- Rising resistance rates could drive up demand for combination therapies, potentially increasing the price of specific formulations.
- Conversely, aggressive stewardship policies might reduce overall volume, exerting downward pressure.
Impact of New Formulations or Innovations
- The development of novel beta-lactam/beta-lactamase inhibitor combinations (e.g., meropenem-vaborbactam) could supplant Cefepime in some indications, further compressing prices.
Regulatory and Market Risks
- Patent and exclusivity status: the absence of exclusivity paves the way for continued generic proliferation.
- Reimbursement policies: changes in Medicare/Medicaid reimbursement structures could influence hospital purchasing behaviors.
- Antimicrobial stewardship initiatives may favor narrow-spectrum or alternative antibiotics, reducing demand for broad-spectrum agents like Cefepime.
Summary Table of Projected Pricing (2024-2030)
| Year |
Estimated Average WAC per Vial |
Notes |
| 2024 |
$16-20 |
Stabilization amid competition |
| 2025 |
$15-19 |
Continued commoditization |
| 2026 |
$15-17 |
Market stabilization |
| 2027 |
$15-17 |
Minimal price fluctuation |
| 2028 |
$14-16 |
Possible minor reductions |
| 2029 |
$14-15 |
Price stability expected |
| 2030 |
$14-15 |
Long-term plateau |
Key Market Opportunities & Challenges
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Opportunities:
- Focus on hospital procurement channels for volume-based discounts.
- Expansion into emerging markets with high infectious disease burdens.
- Development of optimized formulations for better stability and shelf life.
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Challenges:
- Rising antibiotic resistance diminishing efficacy.
- Market entry of novel antibiotics potentially replacing Cefepime.
- Stringent antimicrobial stewardship reducing unnecessary use.
Conclusion
Cefepime for Injection, USP (NDC 00173-0665), remains a staple in hospital-based antibacterial therapy. Despite price declines driven by intense generic competition and commoditization, steady demand persists due to the drug’s efficacy against critical infections. Prices are projected to decrease modestly over the next decade, stabilizing around $14-17 per vial by 2030, unless unforeseen resistance patterns or regulatory shifts emerge.
Key Takeaways
- Market competition and generics have driven Cefepime prices downward, with current WACs averaging around $20-25 per vial.
- Future price trends suggest stabilization at $14-17 per vial by 2030, contingent on resistance, policies, and competitors.
- Hospitals and healthcare providers should optimize procurement strategies to leverage volume discounts.
- Continuous surveillance on resistance trends is critical to anticipate demand shifts.
- Investment in alternative therapies or formulation innovations could influence long-term market positioning.
FAQs
1. How does antibiotic resistance impact the market for Cefepime?
Rising resistance, particularly among Pseudomonas and Enterobacteriaceae, can reduce Cefepime’s clinical efficacy, leading to decreased demand and potentially driving clinicians toward alternative treatments, which may impact overall market volume and pricing stability.
2. Are new formulations of Cefepime expected to enter the market?
Currently, no new formulations are imminent. Most market activity revolves around generic formulations. However, innovations improving stability or delivery could influence future pricing and market share.
3. How do antimicrobial stewardship programs affect Cefepime sales?
Stewardship initiatives promote judicious use of broad-spectrum antibiotics like Cefepime, potentially reducing unnecessary prescriptions, thus decreasing overall demand and exerting downward pressure on prices.
4. What are the main drivers for price declines in generic Cefepime?
Market saturation, multiple generic entrants, manufacturing efficiencies, and procurement negotiations primarily drive prices downward, making Cefepime increasingly commoditized.
5. Can supply chain disruptions influence Cefepime pricing?
Yes. Global disruptions, especially during pandemics or geopolitical conflicts, can limit supply, potentially temporarily increasing prices or causing shortages. However, over the longer term, competitive pressures tend to mitigate such effects.
Sources:
- IQVIA. (2022). US Hospital and Retail Market Data.
- FDA Drug Approvals and Labeling Records.
- Medicare and Medicaid Services Reimbursement Data.
- Peer-reviewed publications on antibiotic resistance trends.
- Industry reports on generic pharmaceutical pricing dynamics.
