Last updated: March 9, 2026
What is NDC 00456-1525?
NDC 00456-1525 corresponds to "Xerava" (eravacycline), an intravenous (IV) antibiotic approved by the FDA in 2018 for complicated intra-abdominal infections (cIAI). It belongs to the tetracycline class of antibiotics and is indicated for multi-drug resistant (MDR) infections caused by certain bacteria, including Klebsiella pneumoniae, Escherichia coli, and Enterobacter cloacae.
Market Overview
Therapeutic Area and Epidemiology
- Target use: MDR gram-negative bacterial infections in hospital settings.
- Believed prevalence: Increasing due to antibiotic resistance; 2.8 million antibiotic-resistant infections annually in the U.S. (CDC, 2021).
- Main competitors: Carbapenems, colistin, tigecycline, and other newer antibiotics like cefiderocol.
Regulatory and Commercial Status
- FDA approval: 2018.
- Marketing: Developed by Tetraphase Pharmaceuticals, now part of Covis Pharma.
- Current market penetration: Limited, primarily used in hospital settings with high resistance profiles.
Pricing Environment
- Current list price: Approximately $3,500 to $4,000 per vial.
- Vial size: 50 mg/vial.
- Treatment course: Typical regimen involves multiple doses, with per-treatment costs reaching $15,000–$20,000.
Market Dynamics
- The antibiotic market for MDR infections is constrained by high costs, stewardship programs limiting use, and competition.
- Growth driven by rising resistance, particularly in ICU settings.
- Prescribing trends favor new agents in MDR cases; however, adoption is influenced by cost, safety profile, and clinician familiarity.
Price Projections
Short-term (Next 1-2 Years)
- Virus-like plateau: Prices are expected to stay around current levels due to existing competition and procurement negotiations.
- Price volatility: Likely to be minimal; significant discounts or rebates are possible for large hospital systems.
Mid-term (3-5 Years)
- Potential decrease: As generics or biosimilar competition emerges (though not imminent for eravacycline), prices could fall by 10-20%.
- Market expansion: Broader use in outpatient settings is unlikely due to IV administration and high costs.
Long-term (5+ Years)
- Innovation impact: New antibiotics in pipeline may influence pricing.
- Generic entry: Unlikely within this timeframe; patent issues and market exclusivity will dominate pricing.
| Scenario |
Price Trend |
Drivers |
| Conservative |
Stable to slight decline |
Existing competition, hospital procurement negotiations |
| Moderate |
10-20% decrease |
Generic/biosimilar development, increased competition |
| Optimistic |
Competitive pressure |
Emergence of new, more effective or lower-cost alternatives |
Market Entry and Competitive Position
- Key differentiators: Activity against MDR pathogens, IV-only formulation.
- Barriers: High treatment cost, poor oral bioavailability, niche market.
- Partnership opportunities: Collaborations with hospital systems and government agencies could expand use.
Risks and Challenges
- Increasing usage restrictions due to stewardship policies.
- Competition from newer agents such as cefiderocol and plazomicin.
- Price sensitivity in healthcare institutions.
Regulatory and Reimbursement Trends
- FDA approval grants market exclusivity until at least 2028.
- Reimbursement typically aligns with hospital outpatient or inpatient drug formulary agreements.
- Value-based pricing models may emerge considering the high unmet need for MDR infections.
Summary
NDC 00456-1525 (Xerava) occupies a niche in the MDR antibiotic market with limited current growth. Prices are stabilizing close to current levels, with potential for slight declines primarily driven by competitive pressures and pipeline developments. The outlook depends heavily on resistance trends, emerging alternatives, and healthcare system acceptance.
Key Takeaways
- Market penetration remains constrained by high costs, despite clinical need.
- Price stability is expected short-term; moderate decline possible over 3-5 years.
- Competition from newer antibiotics and generics will influence future pricing.
- Adoption depends on pathogen resistance patterns and hospital formulary decisions.
- Investment in pipeline agents and stewardship policies could shape long-term dynamics.
FAQs
1. How does the price of xerava compare to other antibiotics for MDR infections?
It is generally higher per treatment course, ranging from $15,000 to $20,000, compared to older agents like tigecycline, which cost approximately $2,000–$3,000 per course.
2. Are there prospects for generic versions of eravacycline?
Currently, no generic versions exist. Patent expiry is anticipated post-2028, contingent on regulatory and legal developments.
3. What factors could drive significant price reductions?
Introduction of biosimilars, improved competing agents, and increased use of stewardship policies limiting high-cost antibiotic deployment.
4. How does resistance impact the demand for xerava?
Rising MDR pathogen prevalence increases demand; however, stewardship efforts and high costs may limit widespread use.
5. Could oral formulations affect price and market share?
Potentially, yes. An oral version would enable outpatient use, possibly increasing volume and reducing per-course costs, but no such formulation is currently approved.
References
- Centers for Disease Control and Prevention (CDC). (2021). Antibiotic Resistance Threats in the United States, 2019.
- Covis Pharma. (2018). Xerava (eravacycline) Prescribing Information.
- MarketsandMarkets. (2022). Antibiotics Market by Product Type and Application.
