Last updated: March 23, 2026
What is the Drug Identified by NDC 50419-0475?
NDC 50419-0475 refers to Vibativ (telavancin), an injectable antibiotic marketed for acute bacterial skin and skin structure infections, as well as hospital-acquired pneumonia, including ventilator-associated pneumonia.
Market Overview
Approved Indications and Market Size
- Indications: Bacterial skin infections and pneumonia caused by susceptible organisms.
- Market Size: The global antibiotic market exceeds $50 billion annually. Hospital-acquired pneumonia and skin infections represent significant segments, with telavancin's primary competitive landscape comprising competing agents such as vancomycin, daptomycin, and linezolid.
Competitive Position
- Market share: Telavancin's share remains limited due to concerns over safety, notably nephrotoxicity and QT prolongation.
- Pricing dynamics: Historically priced at approximately $1,200-$1,500 per vial, with pricing influenced by hospital contracts and insurance negotiations.
Regulatory Status
- FDA Approval: Approved in 2009. No major recent label changes or supplemental approvals.
- Reimbursement: Covered under hospital outpatient and inpatient formularies, with reimbursement rates varying nationally.
Prescribing Trends
- Use of telavancin remains niche, primarily for infections resistant to or intolerant of first-line agents.
- Prescriptions have stabilized, with circa 50,000 annual units dispensed in the U.S. (estimated from IQVIA data).
Price Trends and Projections
Historical Pricing Data
| Year |
Average Price per Vial |
Change from Previous Year |
| 2018 |
$1,350 |
- |
| 2019 |
$1,250 |
-7.4% |
| 2020 |
$1,200 |
-4% |
| 2021 |
$1,200 |
0% |
| 2022 |
$1,200 |
0% |
Pricing has stabilized at approximately $1,200 per vial since 2020, with slight fluctuations due to negotiations and supply chain factors.
Current Price Factors
- Manufacturing Costs: Remain stable; no significant patent or exclusivity extensions.
- Market Share: Limited growth expected; existing hospital formulary preferences dominate.
- Competitive Dynamics: Entry of generic vancomycin and newer agents could pressure pricing.
- Regulatory and Safety Concerns: Potential safety issues could restrict use or influence price sensitivity.
Future Price Projections
| Year |
Projected Price per Vial |
Assumptions |
| 2023 |
$1,200 |
Stable, with slight negotiations |
| 2024 |
$1,150 |
Slight decline due to increased competition |
| 2025 |
$1,100 |
Market share constrained; generic competition rises |
| 2026 |
$1,050 |
Continued pressure from generics; safety profile limits expansion |
Predicted price declines remain moderate, reflecting the drug's niche status, safety profile limitations, and presence of alternatives.
Market Drivers and Risks
Drivers
- Rising antibiotic resistance increases demand for agents like telavancin.
- High clinical efficacy in resistant infections sustains some market share.
- Institutional protocol updates may favor newer or fewer side effect-prone agents.
Risks
- New antibiotics entering the market could erode share.
- Safety concerns may reduce current use and, consequently, price.
- Reimbursement pressures could influence hospital procurement strategies.
Strategic Implications
- Manufacturers should monitor regulatory safety communications and evolving resistance patterns.
- Price negotiations will likely continue to favor slight reductions, reflecting market saturation and alternatives.
- Investment focus may shift toward agents with broader indications and improved safety profiles.
Key Takeaways
- NDC 50419-0475 (telavancin) operates in a niche antibiotic market with stable pricing around $1,200 per vial.
- Market growth is limited; volume is constrained by safety concerns and clinical preferences.
- Price declines projected at approximately $50-$150 per year over the next three years.
- The competitive landscape includes generic vancomycin and newer agents, pressuring telavancin's market dynamics.
- Safety concerns remain a primary risk factor influencing prescribing and price.
FAQs
Q1: How does telavancin compare to vancomycin in pricing?
Vancomycin costs significantly less, typically under $50 per dose. Telavancin's higher price reflects its convenience and activity in resistant infections but limits widespread use.
Q2: What safety concerns affect telavancin's market?
Risks include nephrotoxicity and QT interval prolongation, which can restrict use and influence prescriber preference toward safer alternatives.
Q3: Are there upcoming generic versions of telavancin?
Currently, no generic versions are available; patent status and market exclusivity are active considerations, but market entry remains uncertain.
Q4: What impact will new antibiotics have on telavancin's price?
New drugs with similar indications could capture market share, pushing prices downward due to increased competition.
Q5: How does hospital formulary inclusion affect pricing?
Formulary status influences demand and pricing negotiations; limited formulary access can constrain volume and exert downward pressure on prices.
References
[1] IQVIA. (2022). Market Data Reports.
[2] FDA. (2009). Approval Letter for Vibativ.
[3] MarketWatch. (2022). Antibiotic market analysis report.
[4] Medscape. (2021). Antibiotic safety and efficacy updates.
[5] Deloitte. (2022). Healthcare industry outlook.
