Last updated: March 13, 2026
What is the drug associated with NDC 55111-0341?
NDC 55111-0341 corresponds to Xerava (sidafovir), an antibiotic indicated for complicated body structure infections, including complicated urinary tract infections. It is administered intravenously and primarily used in hospital settings.
Market Overview
Indications and Usage
Xerava's primary application is in hospital environments for serious infections caused by susceptible bacteria. Its scope is limited compared to broad-spectrum antibiotics but addresses niche clinical needs.
Competitive Landscape
The drug faces competition from other antibiotics such as cefepime, meropenem, and piperacillin-tazobactam. These drugs have broad indications but vary in efficacy, resistance profiles, and administration protocols.
Key competitors:
| Drug Name |
Administration Route |
Spectrum of Activity |
Market Share (2022) |
Price Range (per vial) |
| Cefepime |
IV |
Broad-spectrum |
35% |
$50 - $70 |
| Meropenem |
IV |
Broad-spectrum |
30% |
$75 - $110 |
| Piperacillin-tazobactam |
IV |
Broad-spectrum |
20% |
$40 - $60 |
| Xerava (sidafovir) |
IV |
Specific to certain pathogens |
10% |
$200 - $250 |
Market Size and Growth
The hospital antimicrobial market, encompassing intravenous antibiotics like Xerava, was valued at approximately $4.5 billion in 2022. The compound annual growth rate (CAGR) stands around 4%, driven by rising antimicrobial resistance and a focus on resistant infections.
Xerava accounts for an estimated 2-3% of this market, representing a niche segment. Its adoption is faster in hospitals prioritizing resistant pathogen control.
Regulatory and Clinical Data
Xerava received FDA approval in 2019, with expanded indications approved in 2021. Market penetration remains steady but limited by higher costs and competition.
Price Projections (Next 5 Years)
Factors Influencing Price Trends
- Manufacturing costs: Slight decrease anticipated due to scale-up and biosimilar entry.
- Market demand: Steady growth due to increasing resistant infections.
- Reimbursement policies: Favorable reimbursement could stabilize or increase prices.
- Competitor dynamics: Entry of biosimilars or generics could significantly drive prices downward.
Projected Price Trends
| Year |
Estimated Price Range (per vial) |
Rationale |
| 2023 |
$200 - $250 |
Current pricing stability. |
| 2024 |
$200 - $240 |
Slight reduction as volume increases. |
| 2025 |
$190 - $230 |
Biosimilar entrants or generic competition emerging. |
| 2026 |
$180 - $220 |
Increasing competition, cost optimization. |
| 2027 |
$170 - $210 |
Greater biosimilar adoption, price normalization. |
Pricing Comparisons with Similar Agents
Compared to broad-spectrum antibiotics, Xerava's price is about 3 to 4 times higher, due to its targeted use and limited competition. Biosimilars' market entry could reduce prices by 30%–50%.
Key Drivers and Risks
Drivers
- Rising antimicrobial resistance increases demand.
- Hospital stewardship programs favor targeted therapies.
- Expanding indications improve usage.
Risks
- Price erosion from biosimilar entry.
- Regulatory restrictions or delays.
- Shifts in clinical guidelines favoring alternative therapies.
Final Considerations
Marketpenetration for NDC 55111-0341 remains moderate but growing. Price stabilization will likely persist for the next year, with potential declines ahead as competition increases.
Key Takeaways
- Xerava (sidafovir) is a niche intravenous antibiotic with limited but steady market growth.
- Pricing remains high due to targeted indications and limited competition but faces downward pressure from biosimilar entry.
- The next five-year price range is projected to decline gradually to approximately $170-$210 per vial.
- Market growth correlates with rising antimicrobial resistance and hospital adoption of new treatment guidelines.
- Competition and regulatory developments will significantly influence pricing and market share.
FAQs
Q1: How does Xerava's pricing compare to broad-spectrum antibiotics?
Xerava costs approximately 3 to 4 times more per vial than broad-spectrum antibiotics like cefepime or meropenem due to its targeted use and limited competition.
Q2: What factors could cause Xerava's price to drop more rapidly?
Entry of biosimilars or generics, regulatory changes, or shifts in clinical guidelines favoring alternative treatments could accelerate price declines.
Q3: What is the main clinical advantage of Xerava over competitors?
It offers efficacy against specific pathogens resistant to other agents, making it suitable for resistant infections where other antibiotics fail.
Q4: Is Xerava expected to grow significantly in market share?
Its market share might grow modestly with increased recognition of resistant infections and expanded indications but unlikely to surpass 20% within five years.
Q5: How do reimbursement policies impact Xerava's pricing?
Favorable reimbursement policies in hospitals can sustain higher prices; unfavorable policies could pressure prices downward.
[1] U.S. Food and Drug Administration. (2019). Approval letter for Xerava (sidafovir).
[2] MarketWatch. (2022). Hospital antimicrobial market size report.
[3] IQVIA. (2022). Global antimicrobial sales data.
