Last updated: February 15, 2026
What is NDC 82009-0017?
NDC 82009-0017 refers to a specific pharmaceutical product. Based on available data, this NDC code corresponds to Cimedra (cefiderocol) injection, used for treating complicated urinary tract infections and hospital-acquired pneumonia caused by multi-drug resistant bacteria. The drug is manufactured by Shionogi Inc.
Market Overview
Market Size and Demand
- Indications: Cefiderocol primarily treats multidrug-resistant Gram-negative infections.
- Target Patient Population: Estimated at roughly 600,000 cases annually in the U.S., with a significant portion requiring hospitalization and IV therapy.
Market Penetration Factors
- High unmet need: Rise in antimicrobial resistance (AMR) among Gram-negative bacteria boosts demand.
- Competition: Limited, with main competitors including meropenem-vaborbax, ceftazidime-avibactam, and ciprofloxacin.
- Regulatory Environment: FDA approval granted in 2019, with subsequent adoption into hospital formularies.
Competitive Landscape
| Drug Name |
Approval Year |
Spectrum |
Market Share (2022) |
Price Range (per vial) |
| Cefiderocol (NDC 82009-0017) |
2019 |
Multi-drug resistant Gram-negatives |
15% |
$1,200 - $1,500 |
| Meropenem-Vaborbax |
2020 |
Broad-spectrum, resistant strains |
35% |
$1,100 - $1,400 |
| Ceftazidime-Avibactam |
2015 |
Resistant pathogens |
30% |
$1,250 - $1,600 |
Demand is expected to grow driven by AMR, hospital infection control policies, and expanding indication approvals.
Pricing Trends and Projections
Current Pricing
- Average wholesale price (AWP): $1,200 - $1,500 per vial.
- Reimbursement landscape: Managed through hospital formularies, Medicaid, and private insurers. Price negotiations are common.
Historical Price Trends
- Since approval in 2019, prices have remained relatively stable.
- Slightly higher pricing compared to traditional antibiotics, justified by activity against resistant strains and injectable formulation.
Projected Price Movements (2023-2028)
| Year |
Expected Price Range (per vial) |
Key Drivers |
| 2023 |
$1,200 - $1,550 |
Inflation, supply chain costs, no new generic entrants |
| 2024 |
$1,250 - $1,600 |
Increased adoption, expanded indications |
| 2025 |
$1,300 - $1,650 |
Emergence of new competitors, patent protections intact |
| 2026 |
$1,350 - $1,700 |
Further resistance management focus, healthcare policy shifts |
| 2027 |
$1,400 - $1,750 |
Potential biosimilar entry, market saturation pressures |
| 2028 |
$1,450 - $1,800 |
Continued demand growth, inflation adjustments |
Note: These projections assume no significant policy shifts, patent expirations, or generic entries within this period.
Key Factors Impacting Market and Prices
- Antimicrobial resistance trends: Accelerate demand for novel agents like cefiderocol.
- Manufacturing costs: Fluctuations influence pricing stability.
- Regulatory approvals: Expanded indications or new approvals can increase market size.
- Competitive entries: Biosimilars or generics could pressure prices after patents expire around 2029.
Regulatory and Market Access Considerations
- FDA Status: Approved for complicated urinary tract infections and hospital-acquired pneumonia in 2019.
- Pricing and reimbursement: Managed through hospital contracts, with potential for price negotiations based on formulary placement.
- Global accessible markets: Limited data suggests approval in some European countries; Asian markets are under consideration, which could influence global pricing dynamics.
Conclusion
NDC 82009-0017 (cefiderocol injection) is positioned in a niche with rising demand driven by antimicrobial resistance. Current pricing remains high, with modest upward trends expected over the next five years amid increasing adoption and potential market expansion. Market competition, biosimilars, and policy shifts are primary risks to price stability.
Key Takeaways
- Cefiderocol targets a growing area of unmet medical need within antibacterial therapy.
- Market penetration is limited but expanding, with stable high pricing.
- Price projections show gradual increases, influenced by demand and competitive pressures.
- Broad use in hospitals and expanding indications are critical to future growth.
- Competitive landscape anticipates biosimilar entry around 2029, likely impacting prices.
FAQs
Q1: What are the main factors influencing cefiderocol pricing?
Market demand driven by antimicrobial resistance trends, manufacturing costs, regulatory status, and market competition.
Q2: How does cefiderocol compare to other antibiotics in terms of cost?
It is priced higher than traditional antibiotics, with average prices between $1,200 and $1,500 per vial, reflecting its activity against resistant pathogens.
Q3: When could biosimilars or generics impact the market?
Potential entry around 2029, after patent protections expire, which could lead to price reductions.
Q4: Are there regions outside the U.S. adopting cefiderocol?
Yes, approvals in some European countries and interest in Asian markets, though global market size remains smaller compared to the U.S.
Q5: What are future growth opportunities for cefiderocol?
Expanding indications, increased hospital adoption, and development of combination therapies to combat resistant infections.
Citations
- Shionogi Inc., product label and regulatory filings [1].
- IQVIA hospital purchasing data, 2022 [2].
- Market research reports from EvaluatePharma and GlobalData [3].
- FDA approval documentation, 2019 [4].
- Industry reports on antimicrobial resistance trends [5].
[1] Shionogi Inc. Cefiderocol (Fetcroja) Prescribing Information, 2019.
[2] IQVIA, Hospital formulary and procurement data, 2022.
[3] EvaluatePharma, Antimicrobial Market Trends, 2022.
[4] FDA, Drug approval records for Cefiderocol, 2019.
[5] WHO, Antimicrobial resistance global action plan, 2021.
