Last updated: February 24, 2026
What is the Status and Indication of NDC 82009-0003?
NDC 82009-0003 refers to XERAVA (eravacycline), an intravenous antibiotic marketed by Tetraphase Pharmaceuticals. Approved by the FDA in 2019, it targets complicated intra-abdominal infections (cIAI) caused by susceptible bacteria, including multidrug-resistant strains of Enterobacteriaceae.
Market Size and Demand Dynamics
Current Market Landscape
The global antibiotics market valued at approximately USD 50 billion in 2022, with the hospital and specialized care segments representing the largest shares. The demand for broad-spectrum antibiotics like eravacycline is driven by increasing antimicrobial resistance (AMR), particularly in intra-abdominal infections.
Target Patient Population
- Estimated annual cases of cIAI in the U.S.: 300,000. (CDC)
- High-risk patients with multidrug-resistant infections comprise approximately 15-25% of these cases.
- Market penetration is influenced by clinical adoption, with initial accounts favoring hospital formularies with strategic antimicrobial agents.
Competitive Environment
Major competitors include:
- Carbapenems (e.g., meropenem, imipenem)
- Tigecycline
- Ceftazidime-avibactam
- Cefiderocol
These drugs have established market presence, pricing, and sales channels.
Price and Reimbursement Analysis
Current Pricing
- Wholesale Acquisition Cost (WAC): Around USD 600 - 700 per 100 mg vial.
- Average Treatment Course: 2-3 vials daily over 5-7 days, totaling USD 3,000 - USD 4,900 per course.
- Average Selling Price (ASP): Slightly lower than WAC, approximately USD 550 - USD 650 per vial.
Reimbursement Considerations
- Reimbursement rates are aligned with hospital and payer policies.
- Medicare and private insurers reimburse based on ASP plus negotiated discounts.
- The inclusion of eravacycline in antimicrobial stewardship protocols can influence utilization and pricing strategies.
Market Access and Pricing Trends
- New antibiotics often face pricing pressures due to antimicrobial stewardship efforts, which aim to curb overuse.
- Limited specialty drug discounts are common in hospital contracts.
- Risk-adjusted pricing models are gaining favor, especially for drugs targeting multidrug-resistant infections.
Price Projections (Next 5 Years)
| Year |
Estimated Price per Vial (USD) |
Notes |
| 2023 |
USD 600 |
Current market price, stable with minor discounts |
| 2024 |
USD 580 |
Slight downward pressure due to generic entries or alternative therapies |
| 2025 |
USD 560 |
Increasing adoption may support price stabilization |
| 2026 |
USD 550 |
Price plateau expected amid enhanced stewardship and competition |
| 2027 |
USD 540 |
Continued pressure from biosimilars or generics, if approved |
Note: These are estimates based on historical pricing trends in the antimicrobial market, taking into account inflation, R&D expenditure recovery, and market competition.
Future Market Drivers
- Rising prevalence of multidrug-resistant infections.
- Growing adoption of eravacycline in hospital settings for treatment-resistant infections.
- Potential for expanded indications, such as complicated urinary tract infections, may influence volume and pricing.
- Patent exclusivity expected to expire around 2030, risking generic entry and substantial price reduction.
Risks and Opportunities
- Risks: Entry of generics, policy shifts toward antimicrobial stewardship reducing usage, slow clinical adoption.
- Opportunities: Expansion into new indications, improved insurance coverage, targeted marketing to infectious disease specialists.
Key Takeaways
- NDC 82009-0003 (XERAVA) operates in a high-value, competitive market with USD 3,000 – USD 5,000 treatment costs.
- Current prices per vial are approximately USD 600, with projected decline to USD 540–USD 550 over five years.
- Market growth hinges on antimicrobial resistance trends, clinical acceptance, and regulatory developments for new indications.
- Competition and patent expiration pose the primary risks to sustained pricing and market share.
FAQs
1. How does XERAVA compare in efficacy to other antibiotics for intra-abdominal infections?
XERAVA demonstrates comparable or superior efficacy to carbapenems and tigecycline in clinical trials, especially against multidrug-resistant organisms, with a favorable safety profile.
2. What are the barriers to increasing market penetration for NDC 82009-0003?
Clinical familiarity with existing antibiotics, formulary restrictions, antimicrobial stewardship policies, and high treatment costs limit wider adoption.
3. What regulatory developments could influence future pricing?
Potential approval for additional indications, biosimilar or generic entry post-patent expiry, and changes in reimbursement policies could impact pricing dynamics.
4. Are there geographic regions with higher potential for expansion?
Europe, Asia-Pacific, and Latin America show increasing demand for novel antibiotics, driven by rising antimicrobial resistance and limited access to advanced therapies.
5. What strategies could extend the market lifespan of eravacycline?
Obtaining approval for broader indications, demonstrating cost-effectiveness, and integrating into stewardship programs may sustain demand and pricing.
References
- CDC. (2021). Antibiotic Resistance Threats in the United States, 2019. CDC.
- MarketWatch. (2023). Global antibiotics market analysis.
- Federal Drug Administration. (2019). Premarket approval of Xerava.
- IQVIA. (2022). US antimicrobial market data report.
- Pharmaceutical Research and Manufacturers of America (PhRMA). (2021). R&D and pricing in antimicrobials.
[1] U.S. Food and Drug Administration. (2019). FDA approves Xerava to treat certain serious bacterial infections.
[2] CDC. (2021). Antibiotic resistance threats in the United States.
