NDAORALTABLETPriority 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, skin and soft tissue infections and 6 more indications. First approved in 2000.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZYVOX (linezolid) is an oxazolidinone antibiotic approved in 2000 that inhibits bacterial protein synthesis to treat serious gram-positive infections including MRSA, pneumonia, and skin/soft tissue infections. It is unique among antibiotics for its excellent oral bioavailability (approximately 100%), allowing seamless oral-to-IV switching without dose adjustment. The drug distributes well to infected tissues and achieves therapeutic concentrations across multiple body compartments.
LOE Approaching
As LOE approaches, the brand team will shift focus toward lifecycle extension strategies, cost optimization, and maximizing remaining exclusivity period through indication expansion or formulation innovations.
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.