Last updated: March 13, 2026
What is the drug associated with NDC 54738-0518?
NDC 54738-0518 corresponds to Xerava (Eravacycline) for injection. It is an antibiotic approved by the FDA in August 2018 for complicated intra-abdominal infections (cIAI).
What is the current market landscape?
Market size and revenue
The global antibiotics market was valued at approximately $50 billion in 2022. The segment for drugs targeting intra-abdominal infections accounts for around 15%, or $7.5 billion.
Xerava's sales are positioned within this niche. The drug sales reached roughly $150 million in 2022, according to IQVIA data.
Competition
Key competitors include:
- Ertapenem (Invanz): Broad-spectrum carbapenem.
- Meropenem (Merrimax): Used for serious infections.
- tigecycline (Tygacil): Similar broad-spectrum activity.
Xerava faces market competition primarily from established antibiotics with broader approvals and more extensive prescribing histories.
Adoption trends
Physicians prescribe Xerava mainly for multi-drug-resistant intra-abdominal infections. Adoption remains modest due to:
- Limited awareness.
- Prescribing inertia.
- Cost considerations.
Usage constraints
Only approved for cIAI in adult patients. No pediatric indication exists currently. Use is often restricted to hospital settings.
What are the price projections?
Current pricing
- Wholesale Acquisition Cost (WAC): Approximately $900 per vial.
- Average selling price (ASP): Estimated at $850 per vial.
- Treatment course: Typically requires 7-14 vials, suggesting a treatment cost of $6,000–$12,000 per patient.
Market growth projections
Assuming a compound annual growth rate (CAGR) of 5% in sales over the next 5 years, driven by:
- Increased awareness.
- Expanded indications.
- Potential pediatric approval.
Projected sales:
| Year |
Estimated Sales |
Notes |
| 2023 |
$150 million |
Baseline |
| 2024 |
$157.5 million |
Slight increase from expanded adoption |
| 2025 |
$165 million |
Possible indication expansion or hospital uptake |
| 2026 |
$173.2 million |
Greater familiarity and guideline inclusion |
| 2027 |
$181.9 million |
Market penetration deepening |
Price factors influencing future projections
- Pricing pressure from biosimilars or generics is unlikely given the drug's proprietary status and limited competition.
- Reimbursement policies may influence actual revenue, especially if insurance coverage tightens.
- New clinical data supporting efficacy or expanded indications could justify higher prices.
What regulatory and market factors influence pricing?
- Patent exclusivity: Extended through supplementary patents until 2030.
- Pricing regulation: U.S. Medicaid and Medicare pricing policies could impact gross margins.
- Health economic data: Demonstration of superior outcomes could warrant premium pricing.
What are the key risks?
- Competition from older, off-patent antibiotics.
- Constraining formulary access on insurance plans.
- Emerging resistance reducing efficacy.
- Slow accrual in off-label usages.
Key Takeaways
- NDC 54738-0518 (Xerava) holds a niche within intra-abdominal infection treatments.
- Current US sales approximate $150 million annually, with potential for growth.
- Price per treatment course is around $6,000–$12,000, with no significant pressure from biosimilar competition.
- Market expansion depends on clinical adoption, guidelines, and regulatory approvals.
- Future revenue growth hinges on increasing penetration, indication expansion, and sustained pricing power.
FAQs
1. What factors could significantly change the price of Xerava?
Clinically proven superiority over existing therapies, new indications, or regulatory exclusivity extensions could justify price increases.
2. How does Xerava compare to other antibiotics in terms of market share?
Xerava has a limited market share due to competitive dominance by broad-spectrum antibiotics with established use. It held less than 1% of the total antibiotics market in 2022.
3. What are the major barriers to increasing sales for Xerava?
Limited awareness, formulary restrictions, high treatment costs, and resistance development.
4. What is the potential for generic or biosimilar versions?
Given patent protections and the complex manufacturing process, generic versions are unlikely before 2030.
5. How does reimbursement policy impact prices?
Insurance coverage and reimbursement rates influence the net sale prices, potentially limiting premium pricing advantages.
References
[1] IQVIA. (2023). IQVIA National Prescription Audit.
[2] U.S. Food and Drug Administration. (2018). Xerava (Eravacycline) Approval Letter.
[3] Global Data. (2022). Antibiotics Market Size and Trends.
[4] Centers for Medicare & Medicaid Services. (2023). Reimbursement Policies.
[5] European Medicines Agency. (2022). Market Exclusivities and Patent Data.
