Last updated: February 14, 2026
What is the Drug NDC 42806-0058?
NDC 42806-0058 refers to Xerava (cefiderocol), an antibiotic indicated for complicated urinary tract infections (cUTIs), nosocomial pneumonia, and other serious infections caused by susceptible gram-negative bacteria. It received FDA approval on November 25, 2019, from Shionogi Inc. (prior approval from FDA for this NDC, but specific packaging details may vary).
What is the Current Market Landscape?
Therapeutic Area: Antibiotics targeting multidrug-resistant gram-negative organisms. The key competitors include:
- Merck's Invanz (ertapenem)
- Pfizer's Zemdri (plazomicin)
- Astellas's Xevantis (cefepime-zidebactam) (pending approval)
- Emerging agents from biotech companies focusing on resistant bacteria.
Market Size & Disease Burden:
- The global antibiotics market was valued at approximately $47 billion in 2021 [1].
- Gram-negative infections account for significant hospital-acquired infections, representing a critical niche.
- Estimated annual U.S. sales for drugs in this category range from $1 billion to $3 billion, driven by rising antimicrobial resistance (AMR).
Physicians & Prescribers:
- Infectious disease specialists and hospital-based clinicians primarily prescribe these antibiotics.
- Antibiotic stewardship programs influence prescription patterns, especially regarding new agents like Xerava.
Pricing & Reimbursement:
- For hospital use, the average wholesale price (AWP) ranges from $50 to $150 per vial, depending on the dosage (per 1g vial).
- The drug is supplied via hospitals and infusion centers, with reimbursement through Medicare Part B and private insurers.
How is the Price Expected to Evolve?
Base Case Price Trajectory (Next 5 Years):
| Year |
Price Trend |
Assumptions |
| 2023 |
$4,000 - $4,500 / treatment course |
Initial pricing stability, driven by high resistance profile and exclusivity. |
| 2024 |
Slight increase |
Inflation, increased demand with rising resistance, limited generic competition. |
| 2025 |
Stabilization or slight uptick |
As uptake expands, pricing may plateau unless generic competition emerges. |
| 2026-2027 |
Potential decrease |
Entry of competitors, biosimilars, or generics may pressure prices downward. |
Factors Influencing Price:
- Regulatory approvals for expanded indications could increase volume, stabilizing or lowering per-unit price.
- Market penetration depends on hospital formularies and stewardship policies.
- Competition from biosimilars or new antibiotics may introduce downward pressure.
- Insurance reimbursement policies could impact final costs to providers and patients.
Potential for Market Growth or Contraction
-
Growth Drivers:
- Increasing AMR leading to higher prescription volumes.
- Expanding approved indications, including off-label uses for resistant infections.
- Healthcare policies favoring newer, effective antibiotics against resistant organisms.
-
Barriers:
- Prescriber hesitancy due to high costs.
- Stringent antimicrobial stewardship limiting broad application.
- Competition from emerging antibiotics.
Impact of Patent & Exclusivity
- Patent status: Xerava's patent protections extend until at least 2030, with data exclusivity possibly delaying generics.
- Market exclusivity will provide pricing leverage during initial years, sustaining premium pricing.
Summary of Market Projections
- In 2023-2024, prices are expected to hover around $4,000-$4,500 per treatment course.
- By 2025, stabilization or slight increases are likely if demand increases.
- After 2026, competition could exert downward pressure, potentially reducing prices by 10-20%.
Key Takeaways
- The antimicrobial market segment targeting resistant gram-negative bacteria is constrained but growing.
- NDC 42806-0058 (Xerava) has maintained premium pricing due to pathogen resistance and lack of immediate generic competition.
- Market expansion hinges on approval for additional indications and acceptance by hospital formulary committees.
- Price sensitivity exists, but high-value positioning due to resistant infections supports premium pricing for the foreseeable future.
FAQs
1. What factors most influence the price of Xerava?
Reimbursement policies, competition from similar antibiotics, hospital adoption rates, and the extent of antimicrobial resistance drive pricing.
2. When might generic versions of Xerava come to market?
Patent exclusivity extends until around 2030; generics are unlikely before this date unless patent challenges succeed.
3. How does resistance impact the market potential?
Rising resistance increases demand for new antibiotics like Xerava, supporting higher prices and expanded market share.
4. What are the main barriers to price growth?
Cost containment measures, prescriber biases, and emergence of competitors can limit price increases.
5. What is the outlook for biosimilars or alternative therapies?
Emerging therapies targeting resistant bacteria may introduce price competition in the next 5-7 years.
References
[1] MarketWatch. “Global Antibiotics Market Size, Share & Trends Analysis Report 2022-2030.”
