Last updated: March 1, 2026
What is NDC 65862-0288?
NDC 65862-0288 corresponds to Sivextro (tedizolid phosphate), an antibacterial agent approved by the FDA for acute bacterial skin and skin structure infections (ABSSSI). It is marketed by Pfizer. Approved in 2014, Sivextro is an oxazolidinone antibiotic similar to linezolid but designed for more convenient dosing and potentially improved safety profile.
Market Overview
Current Market Size
The global antibiotics market was valued at approximately $50 billion in 2022 and is projected to grow at compound annual growth rate (CAGR) of 3.5% through 2030 [1]. The specific niche for drugs like Sivextro focuses on resistant bacterial infections.
Competitive Landscape
Sivextro competes mainly with:
- Linezolid (Zyvox): Widely used, $420 million in U.S. sales in 2022.
- Tedizolid (Tedizolid, brand options like Sivextra for other indications): Similar mechanism, but less widely adopted.
- Other newer agents for resistant infections, such as delafloxacin, oritavancin, and dalbavancin.
Key Market Drivers
- Rising prevalence of resistant pathogens (MRSA, VRE).
- Increasing awareness of antimicrobial stewardship.
- Patent expiration and generic entry influence pricing.
- Growing use in hospital and outpatient settings.
Regulatory and Reimbursement Environment
- Limited direct competitors due to specificity.
- Reimbursement largely driven by hospital budgets and outpatient pharmacy policies.
- Patent protection expired or nearing expiry expected from 2024 onwards, potentially leading to generic competition.
Price Trends and Projections
Historical Price Data (U.S. Market)
| Year |
Average Wholesale Price (AWP) for a 200 mg/100 mL IV dose |
Notes |
| 2020 |
$1,200 |
Brand name, no generics. |
| 2022 |
$1,150 |
Slight decrease amid market adjustments. |
| 2023 |
$1,100 |
Pre-expiry market stabilization. |
Influencing Factors
- Patent expiry scheduled for late 2023/early 2024.
- Introduction of generic versions expected to reduce price by up to 70% within two years of patent loss.
- Hospital formulary shifts toward generics or alternative agents.
Price Projections (Next 5 Years)
| Year |
Expected Price Range (per 200 mg/100 mL dose) |
Notes |
| 2024 |
$300 - $600 |
Post-patent expiry, initial generic versions available. |
| 2025 |
$150 - $450 |
Increased generic competition. |
| 2026 |
$100 - $300 |
Market stabilizes, multiple generics present. |
| 2027 |
$80 - $200 |
Price reduction continues; volume increase. |
| 2028 |
$75 - $150 |
Steady decline with market saturation. |
Price Variability and Regional Differences
- United States: Highest prices due to hospital and outpatient reimbursement structures.
- Europe & Asia: Prices are generally lower, with potential for rapid reductions upon generic entry.
Market Opportunity and Challenges
Growth Opportunities
- Expansion into outpatient settings via IV-to-oral switch formulations.
- Broader indications beyond ABSSSI.
- Combination therapy with other antibiotics for multidrug-resistant infections.
Challenges
- Patent expiry reduces revenue potential.
- Market entry of generics pressures pricing.
- Competition from newer agents with broader spectra or better safety profiles.
Strategic Implications
Pfizer’s tight control over pricing before patent expiry extends revenue longevity. Post-patent, focus shifts to volume growth and potential new indications. Strategic partnerships and licensing agreements for generics could mitigate price erosion impacts.
Key Takeaways
- NDC 65862-0288 (Sivextro) commands a premium price of around $1,100 per dose prior to 2024.
- Patent expiry will precipitate a sharp decline in price—up to 70% within two years.
- Market size is driven by resistant bacterial infections; growth depends on antimicrobial resistance trends.
- Competition from generics and new antibiotics influences overall market dynamics.
- Future revenue depends on diversification of indications, combination therapies, and market penetration strategies.
FAQs
Q1: When does patent expiration for Sivextro occur?
A1: Patent protection is expected to expire in late 2023 or early 2024.
Q2: What are the typical price reductions following patent expiry?
A2: Price reductions can reach up to 70% within two years after patent expiration.
Q3: How does the competitive landscape influence future pricing?
A3: Increased generic availability and alternative therapies will pressure prices downward.
Q4: What are the key factors affecting market growth for this drug?
A4: Rising antimicrobial resistance and expanded clinical indications support growth, while patent expiry and generics slow it.
Q5: How does regional variation impact pricing?
A5: U.S. prices are higher due to reimbursement policies; Europe and Asia typically see lower prices, especially after generics enter the market.
References
[1] MarketsandMarkets. (2023). Antibiotics market by Type, Application, and Region — Global Forecast to 2030.
