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 9h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
KETEK (telithromycin) is a ketolide antibiotic indicated for community-acquired pneumonia of mild to moderate severity caused by Streptococcus pneumoniae, including multi-drug resistant isolates. It is administered orally as an 800-mg once-daily tablet and works by inhibiting bacterial protein synthesis through binding to the ribosome.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), indicating reduced team expansion and focus on transition planning.
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.