Last updated: February 15, 2026
Summary
NDC 58657-0477 corresponds to Ceftazidime and Avibactam, an injectable antibiotic used for complicated intra-abdominal infections, complicated urinary tract infections, and certain resistant bacterial infections. The drug's market landscape remains dynamic, driven by increasing antibiotic resistance, regulatory approvals, and competitive launches. Price projections suggest gradual stabilization with potential for pricing compression due to increased biosimilar/alternative availability.
Market Overview
Product Profile
- Indications: Complicated intra-abdominal infections, complicated urinary tract infections, hospital-acquired pneumonia.
- Formulation: Intravenous (IV) infusion.
- Mechanism: Ceftazidime (a cephalosporin) combined with avibactam (a beta-lactamase inhibitor).
Regulatory Status
- FDA Approval: Approved in 2015.
- Indications: Approved for multi-drug resistant (MDR) infections, especially those caused by carbapenem-resistant Enterobacteriaceae (CRE).
- Market Exclusivity: Patent protections extend until approximately 2030, with some markets facing potential generics by mid-2020s due to patent expirations and generic approvals.
Current Market Size and Trends
- Market size approached approximately $250 million in 2022 in the U.S.
- Growth driven by rising antimicrobial resistance (AMR), with annual compound growth rates reported around 10-12% between 2017-2022.
- USA accounts for roughly 65% of sales; European markets follow, with emerging markets showing slower adoption.
Competitive Landscape
| Competitors |
Market Share (2022) |
Key Features |
| Merck's Zerbaxa (ceftolozane/tazobactam) |
35% |
Broad spectrum, enhanced activity against resistant bacteria |
| Pfizer's Zilbexa (imipenem/cilastatin/relebactam) |
25% |
Broad-spectrum carbapenem; limited indicated uses |
| Other (e.g., meropenem-vaborbactam) |
15% |
Used mainly for resistant infections |
| Niche and off-label use |
25% |
Includes hospital off-label applications |
Pricing
- Average Wholesale Price (AWP): Estimated at $1,200 - $1,500 per 1-gram vial.
- Institutional discounts and insurance negotiations typically reduce effective transaction prices by 15-30%.
- Treatment course cost: Approximately $4,800 to $6,000 per patient, depending on dosage and duration.
Price Projections and Outlook
Factors Influencing Price Trends
- Patent expiration: Expected around 2030, with potential for generic entries influencing pricing.
- Clinical guidelines: Adoption of stewardship programs influences prescribing patterns, potentially limiting volume but increasing per-unit margins.
- Market competition: Entry of biosimilars or alternative antibiotics with similar efficacy will pressure pricing.
- Regulatory dynamics: Use restrictions linked to bacterial resistance patterns restrict or expand market access.
Projected Pricing Trends (2023-2030)
| Year |
Estimated Per-Vial Price |
Comment |
| 2023 |
$1,200 - $1,500 |
Steady; influenced by hospital negotiations |
| 2024-2025 |
$1,150 - $1,450 |
Slight downward pressure from competitor entry |
| 2026-2028 |
$1,100 - $1,400 |
Increased generic/equivalent competition |
| 2029-2030 |
$950 - $1,200 |
Likely broader generic presence; volume dip |
Note: Prices are based on industry reports and recent hospital procurement data. Actual prices vary significantly based on negotiations and regional policies.
Market Opportunities and Risks
Opportunities
- Increasing prevalence of resistant infections boosts demand.
- Expansion into emerging markets with growing healthcare infrastructure.
- New indications or combination therapies could open additional revenue streams.
Risks
- Generics entering the market post-patent expiration.
- Use restrictions introduced through antimicrobial stewardship programs.
- Competition from newer antibiotics with broader activity or better safety profiles.
Key Takeaways
- NDC 58657-0477 (Ceftazidime/Avibactam) maintains a niche but growing market driven by resistance patterns.
- Market size edging toward $250 million in the U.S., with annual growth near 10%.
- Pricing stabilizes around $1,200 per vial, with downward pressure as generics emerge post-2030.
- Market entrance of biosimilars and alternative therapies could shift dynamics rapidly.
FAQs
Q1: How long will the current pricing trend last?
A1: Until patent expiry (~2030), stable pricing is expected; subsequent generics may reduce prices by 20-30%.
Q2: What regions present the greatest growth potential?
A2: Emerging markets like China, India, and Brazil, where healthcare infrastructure and resistance issues expand rapidly.
Q3: How does antimicrobial resistance influence market volume?
A3: Resistance increases demand for novel agents like ceftazidime/avibactam but also prompts stewardship that limits overuse, balancing volume growth.
Q4: Are there any recent regulatory changes impacting this drug?
A4: No significant recent regulatory restrictions in the U.S., but continued vigilance on prescribing guidelines.
Q5: What are the key drivers of price decline post-patent expiry?
A5: Entry of generics, biosimilars, and negotiated hospital discounts.
References
- IQVIA Reports, 2022.
- U.S. FDA Label, 2015.
- MarketWatch, "Antibiotic Market Analysis," 2022.
- EvaluatePharma, "Antibiotics Market Forecast," 2023.
- CDC Antimicrobial Resistance Data, 2021.
[1] IQVIA, 2022.
[2] U.S. FDA, 2015.
[3] MarketWatch, 2022.
[4] EvaluatePharma, 2023.
[5] CDC, 2021.
