LEVAQUIN
LOE ApproachingNDAORALSOLUTION
Approved
Oct 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
LEVAQUIN by Johnson & Johnson is [see microbiology(12. Approved for moderate, severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section, nosocomial pneumonia due to methicillinsusceptible staphylococcus aureus and 36 more indications. First approved in 2004.
Drug data last refreshed 2h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LEVAQUIN (levofloxacin) is a fluoroquinolone antibiotic administered orally or intravenously that treats moderate-to-severe bacterial infections across respiratory, skin, urinary, and systemic indications. It works by inhibiting bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication in susceptible gram-positive and gram-negative organisms. The drug demonstrates rapid and nearly complete oral absorption (99% bioavailability) with linear, predictable pharmacokinetics across dosing regimens.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team restructuring and shift toward generic optimization or portfolio reallocation.
Mechanism of Action
[see Microbiology(12.4)]. 12.3 Pharmacokinetics The mean ±SD pharmacokinetic parameters of levofloxacin determined under single and steady-state conditions following oral tablet, oral solution, or intravenous (IV) doses of levofloxacin are summarized in Table 8. Table 8: Mean ±SD Levofloxacin PK…
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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.