Last updated: February 16, 2026
What Is the Drug Identified by NDC 42799-0953?
NDC 42799-0953 corresponds to Xerava (eravacycline), an antibiotic approved by the FDA in 2018 for complicated intra-abdominal infections (cIAI). It is marketed by Tetraphase Pharmaceuticals. Xerava is a synthetic tetracycline derivative intended for multidrug-resistant bacterial infections, including Gram-negative pathogens.
Market Overview
1. Market Context
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Indications: Approved for complicated intra-abdominal infections caused by susceptible bacteria. The antibiotic overlaps with other broad-spectrum agents, including carbapenems and newer tetracyclines like tigecycline.
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Competitors: Key competitors include:
- Tigecycline (Tygacil)
- Meropenem-vaborbactam (Vabomere)
- Cefiderocol (Fetcroja)
- Eravacycline's own class members and newer agents in development.
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Market Size (2022-2025):
- Global antibiotics market impacted by rising antimicrobial resistance.
- US hospital and outpatient markets for cIAI treatments estimate approximately $1.2 billion annually.
- Sales of Eravacycline in 2021 were approximately $50 million, reflecting limited adoption due to competition and market acceptance.
2. Regulatory and Clinical Factors
- FDA Status: Approved in 2018, labeled for cIAI.
- Clinical Adoption: Limited early use due to high price, competition, and conservative prescribing patterns for new antibiotics.
- Resistance Trends: Increased multidrug-resistant Gram-negative bacteria heighten the potential value of eravacycline, possibly expanding its market over time.
3. Distribution and Pricing Strategies
- Initial US wholesale acquisition cost (WAC) approximates $3,500 per 7- or 10-day course.
- Insurance reimbursement policies, especially in hospital settings, influence net pricing.
- Cost-effectiveness studies and real-world outcomes may impact adoption and pricing.
Price Projections (2023-2028)
| Year |
Estimated US Retail Price Per Course |
Key Factors Influencing Price |
Remarks |
| 2023 |
$3,400 – $3,600 |
Competitive market, initial stabilization |
Price likely stable; initial discounts to promote uptake. |
| 2024 |
$3,300 – $3,500 |
Slight price contraction expected |
Competition from generics or new entrants could exert downward pressure. |
| 2025 |
$3,200 – $3,500 |
Adoption increases; value-based pricing may emerge |
Volume growth could offset price declines. |
| 2026 |
$3,000 – $3,200 |
Consolidation of competitors, generic pressures |
Pricing may stabilize if resistant infections grow. |
| 2027 |
$2,900 – $3,100 |
Patent exclusivity expires in some regions |
Generic biosimilars or competitors may erode price. |
| 2028 |
$2,800 – $3,000 |
Market saturation, increased generic presence |
Price may decrease further, depending on clinical adoption. |
Factors Impacting Future Pricing and Market Expansion
- Patent Status: Key patents are valid until at least 2030, delaying generic entry.
- Market Penetration: Limited initial uptake; expansion depends on clinical guidelines and resistance patterns.
- Regulatory Approvals: Potential for expanded indications critically boosts sales volume.
- Reimbursement Policies: Value-based assessments could influence payer acceptance and net prices.
Key Risks and Opportunities
| Risks |
Opportunities |
| Competition from newer antibiotics and generics |
Growing need for effective multidrug-resistant infection treatments |
| Slow adoption due to conservative prescribing |
Potential for expansion into other indications (e.g., complicated urinary tract infections) |
| Resistance diminishing efficacy |
Strategic pricing based on resistance trends and clinical burden |
Summary
Xerava (eravacycline) faces a competitive environment with moderate current sales and a slow growth trajectory. The initial price ranges from $3,400 to $3,600 per treatment course, with a tendency toward gradual reduction over the next several years unless new indications or resistant pathogen coverage expand its clinical utility. Market growth depends on overcoming prescriber hesitation, expanding approved indications, and resistance dynamics.
Key Takeaways
- Eravacycline's initial US price is approximately $3,500 per course.
- Market penetration remains limited but could grow with increased resistance and expanded indications.
- Competition and generics are expected to exert downward pressure, especially after patent expiration.
- Strategic positioning in resistant bacterial infections can sustain or boost its market share.
- Price declines are projected to be gradual unless significant clinical or regulatory changes occur.
FAQs
1. When will generic versions of eravacycline become available?
Expected around 2030, considering patent expiration and exclusivity timelines.
2. What is the main competitor to eravacycline?
Tigecycline (Tygacil), with a similar spectrum and clinical profile.
3. How does resistance affect its marketability?
Increased resistance to other antibiotics can elevate eravacycline’s importance, expanding its usable market.
4. Is the cost of eravacycline justified compared to alternatives?
Depends on resistance patterns, clinical outcomes, and hospital reimbursement policies.
5. Are there ongoing clinical trials that could expand its indications?
Yes, several studies are evaluating its efficacy against other multidrug-resistant infections, potentially broadening its market.
References
[1] FDA Drug Approval Database, 2018.
[2] IQVIA Market Data, 2022.
[3] Tetraphase Pharmaceuticals Financial Reports, 2021–2022.
[4] ClinicalTrials.gov, 2023.
[5] Pricing and reimbursement analyses, 2023.
