KETEK
LOE ApproachingNDAORALTABLET
Approved
Apr 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
KETEK by Sanofi is clinical pharmacology pharmacokinetics absorption following oral administration, telithromycin reached maximal concentration at about 1 hour (0. Approved for community-acquired pneumonia (of mild to moderate severity) due to streptococcus pneumoniae, (including multi-drug resistant isolates [mdrsp mdrsp, multi-drug resistant streptococcus pneumoniae includes isolates known and 2 more indications. First approved in 2004.
Drug data last refreshed 18h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KETEK (telithromycin) is an oral ketolide antibiotic approved in 2004 for community-acquired pneumonia of mild to moderate severity, including multi-drug resistant Streptococcus pneumoniae. It works by inhibiting bacterial protein synthesis and achieves rapid absorption with peak plasma concentrations within 1 hour, followed by distribution to respiratory tissues including bronchial mucosa, epithelial lining fluid, and alveolar macrophages.
LOE Approaching
Product approaching loss of exclusivity with minimal linked job activity, suggesting reduced commercial investment and team contraction.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Following oral administration, telithromycin reached maximal concentration at about 1 hour (0.5 – 4 hours). It has an absolute bioavailability of 57% in both young and elderly subjects. The rate and extent of absorption are unaffected by food…
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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.