SPECTRACEF
LOE Approachingcefditoren pivoxil
NDAORALTABLET
Approved
Aug 2001
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
SPECTRACEF (cefditoren pivoxil) is clinical pharmacology pharmacokinetics absorption oral bioavailability following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Approved for mild to moderate infections in adults, adolescents (12 years of age, older) which are caused by susceptible strains of the designated microorganisms in the conditions listed below. First approved in 2001.
Drug data last refreshed 22h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SPECTRACEF (cefditoren pivoxil) is an oral third-generation cephalosporin antibiotic that treats mild to moderate bacterial infections in adults and adolescents 12 years and older. It works by inhibiting bacterial cell wall synthesis after oral absorption and hydrolysis to active cefditoren. The drug achieves optimal plasma concentrations when taken with food, particularly high-fat meals, which increase bioavailability by up to 70%.
LOE Approaching
Product is approaching loss of exclusivity with stable competitive pressure (30% intensity), indicating potential team downsizing or transition planning within the next 1-2 years.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Absorption Oral Bioavailability Following oral administration, cefditoren pivoxil is absorbed from the gastrointestinal tract and hydrolyzed to cefditoren by esterases. Maximal plasma concentrations (C max ) of cefditoren under fasting conditions average 1.8 ±…
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
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