NDAORALFOR SUSPENSIONPriority Review
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
ZYVOX (linezolid) by Pfizer is 12. Approved for tuberculosis, pneumonia, bacterial infections and 3 more indications. First approved in 2000.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYVOX (linezolid) is an oxazolidinone antibiotic used to treat serious gram-positive bacterial infections, including MRSA, pneumonia, tuberculosis, and skin/soft tissue infections. It works by inhibiting bacterial protein synthesis, with 100% oral bioavailability allowing flexible oral or intravenous dosing without dose adjustment.
LOE Approaching
ZYVOX faces imminent loss-of-exclusivity with declining spending ($7K) and high competitive pressure; brand teams should prepare for transition to generic defense and niche indication strategies.
Mechanism of Action
12.1 Mechanism of Action Linezolid is an antibacterial drug [ see ] . 12.2 Pharmacodynamics In a randomized, positive- and placebo-controlled crossover thorough QT study, 40 healthy subjects were administered a single linezolid 600 mg dose via a 1 hour intravenous infusion, a single linezolid 1,200…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.