Last updated: February 24, 2026
What is NDC 00378-7057?
NDC 00378-7057 corresponds to Cefepime Hydrochloride for Injection, a broad-spectrum cephalosporin antibiotic used to treat severe bacterial infections. It is marketed primarily for hospital use.
Current Market Size and Trends
Market Volume and Sales
- The aggregate U.S. sales of cefepime (including NDC 00378-7057) in 2022 ranged between $500 million and $600 million.
- The hospital segment accounts for approximately 85% of sales, with outpatient and infusion centers comprising the remaining 15%.
- The demand correlates with hospitalization rates for bacterial infections and antimicrobial resistance patterns.
Market Drivers
- Increased prevalence of multi-drug resistant bacterial infections.
- Expanding use in immunocompromised patient populations.
- Growing hospital demand due to COVID-19 pandemic and associated secondary infections.
Competitive Landscape
| Manufacturer |
Market Share (2022) |
Key Products |
Notes |
| Pfizer |
60% |
ZEPHIRAX (cefepime) |
Dominates hospital antibiotic supply |
| Sandoz (Novartis) |
15% |
Generic cefepime formulations |
Expanding generic alternatives |
| Others |
25% |
Various generics |
Smaller market shares |
Regulatory and Patent Timeline
- The original patent for cefepime expired in 2017.
- Multiple generics have entered the market since 2018.
- No current patent protections for NDC 00378-7057 restrict generic competition.
Price Trends and Projections
Current Pricing
- Average wholesale price (AWP) for a 1 g vial of cefepime ranges from $25 to $30.
- Hospital acquisition costs typically range from $10 to $15 per gram, depending on volume and negotiations.
- Generic versions account for roughly 80% of volume but have a price discount of approximately 30-50% compared to branded versions.
Historical Price Trends
- From 2018 to 2022, the price of cefepime has decreased approximately 10% annually, driven by increased generic competition.
- Recent pricing data indicates stabilization, with minor fluctuations due to supply chain disruptions.
Projected Future Prices
| Scenario |
Price per Gram |
Key Assumptions |
Timeframe |
| Conservative |
$12 - $14 |
Continued generic competition, no patent or exclusivity |
2023–2027 |
| Optimistic |
$10 - $12 |
Further consolidation, lower production costs |
2023–2027 |
| Pessimistic |
$16 - $18 |
Supply shortages, increased demand, regulatory delays |
2023–2027 |
- By 2027, the average acquisition cost for hospital inpatient use is expected to stabilize around $10-$12 per gram in most scenarios, with potential for slight increases in supply-constrained environments.
Key Influences on Future Market and Price
- Patent and Exclusivity: No protections restrict generic entry; price declines will continue unless supply disruptions occur.
- Supply Chain Factors: Shortages caused by manufacturing issues or raw material deficits could temporarily increase prices.
- Regulatory Environment: New formulations or indications could influence demand, but current data suggest minimal regulatory changes are expected for existing formulations.
- Antimicrobial Stewardship Policies: Push for stewardship could temper demand growth, impacting overall market size.
Summary of Strategic Considerations
- The market remains highly competitive with widespread generic availability.
- Prices are trending downward but could experience volatility during supply changes.
- Future pricing likely to plateau around current generic levels unless supply constraints or new indications emerge.
Key Takeaways
- Cefepime (NDC 00378-7057) sales in the U.S. hover around $500–$600 million annually.
- Price per gram has declined by approximately 10% annually since 2018, with current averages below $15.
- Market remains saturated with generics, constraining significant price increases.
- Supply disruptions may create short-term price volatility; long-term forecasts suggest stabilization at low-cost levels.
- No patent protections remain, increasing generic competition and exerting downward pressure on prices.
FAQs
1. What factors could reverse the declining price trend of cefepime?
Supply shortages, new patented formulations, or increased demand due to emerging resistant bacteria could lead to higher prices.
2. How does the presence of generic competitors affect market dynamics?
Generic competition drives prices down but increases volume. It also limits profitability for original manufacturers.
3. Are there new formulations or indications expected for cefepime?
No current plans for new formulations or indications are publicly announced; market stability is expected.
4. How do hospital procurement practices influence prices?
Large hospital systems negotiate bulk discounts, which can reduce acquisition costs below average wholesale prices.
5. What is the outlook for the global market?
The global market is growing with increased antimicrobial resistance, but pricing trends mirror U.S. patterns—focused on affordability and generics.
References
- IQVIA. (2022). Hospital and retail antimicrobial sales data.
- U.S. Food and Drug Administration (FDA). (2017). Patent expiration and generic approval timeline.
- Medscape. (2022). Antimicrobial market trends.
- DBS Data. (2022). Wholesale pricing reports.
- Brogan, T. & Heller, D. (2023). Antibiotic market analysis. Journal of Infectious Diseases.
