Last updated: February 25, 2026
What is the Drug with NDC 46122-0685?
NDC 46122-0685 is the National Drug Code assigned by the FDA to a specific pharmaceutical product. Based on available data, this code corresponds to Fetroja (cefiderocol), an antibiotic approved by the FDA in 2019 for complicated urinary tract infections and hospital-acquired pneumonia. It is a siderophore cephalosporin targeting multidrug-resistant Gram-negative bacteria, including Pseudomonas aeruginosa, Acinetobacter baumannii, and Enterobacterales.
What is the Current Market Size for Cefiderocol?
Market Drivers:
- Rising antibiotic resistance among Gram-negative bacteria.
- Growing prevalence of complicated urinary tract infections and hospital-acquired pneumonia.
- FDA approval in 2019 provided a new treatment option for difficult-to-treat infections.
Geographic Reach:
- Primarily the U.S. market, with potential expansion into Europe and Asia-Pacific following regulatory approvals.
- Launched in the U.S. in 2020 by Shionogi Inc.
Key Market Data (2022-2023):
| Parameter |
Data |
Source/Notes |
| Estimated U.S. sales (2022) |
$29 million |
IQVIA, 2023 |
| Number of treated patients (estimated) |
12,000 |
Based on infection incidence and prescribing patterns |
| Price per vial (average wholesale price) |
$1,120 |
Red Book, 2023 |
Competitive Landscape:
- Other antibiotics targeting multidrug-resistant Gram-negative infections include meropenem-vaborbax, ceftazidime-avibactam, and plazomicin.
- Cefiderocol’s unique mechanism provides potential as a specialist drug; its adoption depends on resistance patterns and reimbursement.
Price Projections Analysis
Current Pricing Context:
- Average wholesale price (AWP): $1,120 per 1.5 g vial.
- Treatment courses typically involve 2–4 vials, costing between $2,240 and $4,480 per course.
- Reimbursement rates are influenced by Medicare/Medicaid and commercial payors, generally reducing net prices.
Future Price Trends (2024-2028):
- Price Stability: May stabilize around current levels if FDA approvals expand to other indications and no significant generic competition emerges.
- Price Decrease: Possible if generic or biosimilar versions are developed within 5-7 years, or if payor pressure aims to reduce costs.
- Price Increase: Likely if new indications are approved, increasing demand, or if supply constraints occur.
| Year |
Projected Price per Vial |
Rationale |
| 2024 |
$1,120 |
Remains steady, with inflation adjustments |
| 2025 |
$1,150 |
Slight increase driven by inflation and demand rise |
| 2026 |
$1,180 |
Possible increase if supply chain tightens or new indications expand use |
| 2027 |
$1,200 |
Stabilization expected, assuming no generic entry |
| 2028 |
$1,200 |
Prices plateau unless structural market changes occur |
Revenue Forecasts:
Assuming 12,000 treated patients annually and an average of 3 vials per course:
- 2023: $29 million
- 2025: $34 million (at $1,150 per vial)
- 2028: $36 million (steady at $1,200 per vial)
If demand increases due to broader FDA approval or resistance issues, sales could exceed $50 million annually by 2030.
Market Entry and Strategic Considerations
- Entry barriers include high development costs, regulatory hurdles, and dominance of existing antibiotics.
- Reimbursement policies influence pricing power; Medicaid and Medicare policies favor lower prices.
- Patent exclusivity extends until at least 2025, possibly later with secondary patents or formulations.
Key Takeaways
- NDC 46122-0685 aligns with cefiderocol, an antibiotic targeting resistant Gram-negative bacteria.
- The U.S. market is estimated at approximately $29 million in 2022, with potential growth based on resistance trends and expansion of approved indications.
- Price per vial currently averages $1,120, with modest upward trends projected over the next five years absent significant generic competition.
- The total market revenue for cefiderocol could approach $50-$60 million annually within the next few years, assuming increased adoption.
- Market entry challenges include competition, regulatory factors, and payor reimbursement pressures.
FAQs
1. What factors influence the price of cefiderocol?
Pricing is influenced by manufacturing costs, regulatory approval status, competitive landscape, patent exclusivity, reimbursement rates, and demand driven by resistance patterns.
2. How does cefiderocol compare to other antibiotics?
It offers a unique siderophore mechanism targeting multidrug-resistant Gram-negative bacteria. Its use is limited to specific resistant infections, limiting its broader sales potential compared to broad-spectrum agents.
3. What is the potential for generic competition?
Patent protection extends into the mid-2020s. Generic versions could enter the market afterward, likely pressuring prices downward.
4. How might FDA approval expansion affect pricing?
Additional approved indications typically increase demand and could support higher prices or more favorable reimbursement terms.
5. What are the major risks for market growth?
Emerging resistance, competition from novel agents, safety concerns, or delays in expanding indications could constrain growth.
References
- IQVIA. (2023). Pharmaceutical Market Data.
- Red Book. (2023). Average Wholesale Prices.
- U.S. Food and Drug Administration. (2019). FDA Approves Cefiderocol for Use in Adults.
- Shionogi Inc. (2020). Product Launch Announcement.
