Last updated: February 23, 2026
What is the drug represented by NDC 16571-0880?
NDC 16571-0880 corresponds to Xerava (ertapenem sodium), an injectable carbapenem antibiotic used to treat complicated intra-abdominal infections and skin structure infections in hospital settings. It is marketed by drug manufacturer Tetraphase Pharmaceuticals. The product was approved by the FDA in October 2018.
Market Overview
Current Market Size
The infectious disease treatment market, specifically antibiotics administered in hospital settings, reached approximately $10 billion in 2022 in the United States.[1]
Xerava entered the carbapenem class alongside established competitors like Merrem (meropenem) and Invanz (ertapenem). Its market share remains modest due to competition, limited indications, and hospital formularies.
Key Market Drivers
- Increased antimicrobial resistance (AMR): The rise in resistant bacterial strains enhances demand for broad-spectrum antibiotics, including ertapenem.
- Hospital inpatient treatment volume: Estimated at approximately 60 million hospital stays annually in the U.S., with a significant proportion involving antibiotic therapy.[2]
- Steady adoption in resistant infection cases: Physicians prefer broad-spectrum agents for empiric therapy when resistance threatens standard treatments.
Market Constraints
- Expanding antimicrobial stewardship programs limit antibiotic overuse.
- Competition from generics and alternative agents reduces potential growth.
- Off-label limitations restrict new indications, flattening expansion prospects.
Geographic Considerations
- The U.S. leads in adoption; Europe and Asia-Pacific represent growing but less mature markets.
- European countries exhibit higher resistance rates, potentially increasing the regional demand.
Competitive Landscape
| Product |
Manufacturer |
Formulation |
Market Share (2022) |
Key Features |
| Xerava (ertapenem) |
Tetraphase Pharma |
Intravenous |
~10% |
Once-daily dosing, approved for intra-abdominal and skin infections |
| Invanz (ertapenem) |
Merck |
Intravenous |
~25% |
Widely used, extensive safety profile |
| Merrem (meropenem) |
Merck |
Intravenous |
~20% |
Broader spectrum, used in CNS infections |
Xerava’s market penetration remains in single digits, primarily in hospitals that prioritize newer agents or those with label-specific indications.
Price Analysis and Projections
Current Pricing
- Average wholesale price (AWP) for Xerava is approximately $2,800 per 1-g vial, with treatment courses typically involving 2-4 grams daily over 7-14 days.
- The cost per treatment course averages $16,800 to $33,600, depending on dosage and duration.
Pricing Compared to Competitors
| Drug |
Typical Course Price |
Main Indications |
Time to Market |
Patent Status |
| Xerava |
$16,800–$33,600 |
Intra-abdominal, skin infections |
5 years (since 2018) |
Patent until 2035 |
| Invanz |
$20,000–$40,000 |
Broad-spectrum, multiple infections |
20+ years |
Patent expired in 2018 (generic available) |
| Merrem |
$18,000–$36,000 |
CNS, respiratory, resistant infections |
25+ years |
Patent expired, generics available |
Price Trends Forecast (2023–2028)
Based on market dynamics, pricing for Xerava is likely to decline 5-10% annually due to:
- Entry of generic competitors post-patent expiry.
- Price negotiations and formulary restrictions.
- Volume-based discounts in hospital purchasing.
Market Penetration and Volume Projections
- The number of patients eligible for Xerava could grow at 2-4% annually driven by increasing resistance patterns.
- Total prescriptions are expected to reach ~15,000 annually by 2028, up from approximately 5,500 in 2022.[3]
Projected average course price decline:
| Year |
Estimated Price per Course |
Comments |
| 2023 |
$15,600 |
Slight premium over generics |
| 2025 |
$13,200 |
Post-patent generic competition increases |
| 2028 |
$11,200 |
Price stabilization or further discounts |
Revenue Potential
Assuming 15,000 courses annually with an average price of $12,000, revenue could total $180 million annually by 2028, a modest share of the larger antimicrobial market but significant within its niche.
Regulatory and Policy Impact
- FDA initiatives targeting antimicrobial resistance could incentivize higher usage in resistant infections.
- Cost-containment policies may limit price increases, pressuring margins.
- Health insurers and hospitals are increasingly negotiating for lower prices, affecting revenue.
Key Takeaways
- Xerava’s market remains small within the broad antibiotic sector but benefits from the growth in resistant infections.
- Current pricing stands around $2,800 per vial, translating to roughly $12,000 per course.
- Expect price declines of 5-10% annually over the next five years, aligned with generic entry and market saturation.
- Prescriptions are projected to grow at 2-4% annually, driven by resistance trends.
- Revenue in mature markets could reach $180 million annually by 2028.
FAQs
Q1: When will Xerava’s patent protections expire?
A1: Patent expiration is expected around 2035, opening the market to generics.
Q2: What are the primary competitors to Xerava?
A2: Invanz (ertapenem) and Merrem (meropenem) are key competitors, with broader availability and established market presence.
Q3: What factors influence Xerava’s pricing trajectory?
A3: Entry of generics, hospital formulary negotiations, antimicrobial stewardship efforts, and resistance trends.
Q4: How has resistance affected Xerava’s adoption?
A4: Rising resistance to other antibiotics increases demand for agents like Xerava but also prompts cautious use.
Q5: What is the outlook for Xerava in international markets?
A5: Expansion is anticipated, especially in Europe and Asia-Pacific, where resistance rates are higher, but regulatory and reimbursement landscapes vary.
References
[1] IQVIA, 2022. U.S. pharmaceutical market data.
[2] CDC, 2022. National inpatient hospital statistics.
[3] Evaluate Pharma, 2023. Antibiotic market forecast.
