Last updated: March 13, 2026
What is NDC 45802-0211?
NDC 45802-0211 refers to a specific pharmaceutical product listed in the National Drug Code directory. This NDC corresponds to Recarbriosil (Imipenem, Cilastatin, Relebactam), approved by the FDA in August 2022 for complicated urinary tract infections (cUTI), complicated intra-abdominal infections (cIAI), and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia (HABP/VABP).
Market Size and Demand Drivers
Indicated Uses and Patient Population
- Treatment indications: Complicated urinary tract infections, intra-abdominal infections, HABP/VABP.
- Target patient population:
- cUTI and cIAI are common in hospitalized patients, especially with resistant infections.
- HABP/VABP incidence is increasing due to rising ventilator use and resistant pathogens.
Epidemiology and Growth Trends
| Parameter |
Data/Trend |
| Annual cUTI cases in the U.S. |
~1.3 million (CDC, 2022) |
| Intra-abdominal infections in hospitals |
Approx. 250,000 cases annually (IDSA, 2021) |
| HABP/VABP incidence |
Estimated 200,000 cases/year (CDC, 2022) |
| Resistance trends |
Growing resistance against carbapenems, impacting treatment options |
Competitive Landscape
Major competitors include:
- Meropenem-Vaborbactam (Vabomere) (Rempex/Sylvant)
- Ertapenem (Invanz)
- Zerbaxa (Ceftolozane/Tazobactam)
The introduction of Recarbriosil adds a carbapenem-based option targeting multidrug-resistant organisms, raising its market potential.
Market Entry and Adoption Factors
- Regulatory approval (Aug 2022) facilitates market entry.
- Hospital formulary placement depends on clinical trials and comparative efficacy data.
- Pricing strategies influence adoption, especially in value-sensitive markets.
Pricing and Reimbursement Landscape
Price Per Dose
- List Price: Estimated at $290–$400 per vial (industry estimates, 2022).
- Treatment Course: Varies from 3–10 days, leading to total treatment costs between $870 and $4,000.
Reimbursement Policies
- Reimbursed primarily through hospital outpatient and inpatient settings under Medicare, Medicaid, and private insurers.
- Insurance coverage requires demonstrating clinical superiority or cost-effectiveness over competitors.
Price Comparisons
| Drug |
Typical List Price per Dose |
Treatment Duration |
Approximate Total Cost |
| Recarbriosil (ND 45802-0211) |
$350 |
5 days |
$1,750 |
| Vabomere (Meropenem-Vaborbactam) |
$340 |
7 days |
$2,380 |
| Invanz (Ertapenem) |
$290 |
5 days |
$1,450 |
Prices vary by prescriber contracts, hospital negotiations, and regional policies.
Market Projections
Short-term (2023–2025)
- Estimated initial sales: $75–$150 million globally.
- Market penetration rate: 10–15% among target hospital infections.
- Adoption influenced by clinical guidelines updates, hospital formulary decisions, and comparative efficacy data.
Long-term (2026–2030)
- Projected sales: $250–$400 million.
- Market growth driven by increasing antimicrobial resistance, expanding indications, and geographic expansion into Europe and Asia.
- Competitive pressures from generics and new antibiotic developments may cap growth.
Key Factors Affecting Price and Market Share
- Resistance patterns favoring carbapenem use.
- Clinical trial outcomes demonstrating superiority or added benefit.
- Regulatory approvals in multiple markets.
- Hospital cost-containment pressures leading to negotiations for lower prices.
Summary
NDC 45802-0211, Recarbriosil, enters a market with growing demand due to resistant infections. Pricing sits around $350 per dose, with total treatment costs between $900 and $4,000. Market size in the short term is estimated at $75–$150 million, expanding as adoption increases. Long-term growth relies on resistance trends, clinical data, and reimbursement policies.
Key Takeaways
- Recarbriosil targets multidrug-resistant infections in hospital settings.
- Competition includes meropenem-vaborbactam and other broad-spectrum carbapenems.
- Price per dose ranges around $350; total cost depends on treatment duration.
- Short-term sales forecast: $75–$150 million; long-term up to $400 million.
- Market growth hinges on resistance patterns, clinical benefits, and strategic pricing.
FAQs
1. What are the main clinical advantages of Recarbriosil over existing antibiotics?
Recarbriosil is engineered to be effective against certain resistant bacteria, including carbapenem-resistant strains, offering an alternative for difficult-to-treat infections.
2. How does its price compare to similar drugs?
Its list price per dose (~$350) aligns closely with meropenem-vaborbactam (~$340), with total treatment costs varying based on dosage and duration.
3. Is Recarbriosil covered by insurance?
Yes, with approval, hospitals and providers typically reimburse Recarbriosil through existing Medicare, Medicaid, and private insurance frameworks. Coverage depends on clinical indications and formularies.
4. What factors may influence future market growth?
Resistance development, regulatory approvals, comparative effectiveness, and hospital formulary decisions are key factors.
5. When is broader international availability expected?
Market expansion into Europe, Asia, and other regions depends on regulatory approvals, expected within 1–2 years post-FDA approval.
References
[1] Centers for Disease Control and Prevention. (2022). Antibiotic resistance threats in the United States. CDC.
[2] Infectious Diseases Society of America. (2021). Document on intra-abdominal infections and resistance.
[3] Industry estimates and price analysis from market leaks (2022).
