NDAORALFOR SUSPENSION
Approved
Dec 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
BIAXIN (clarithromycin) by AbbVie is clinical pharmacology pharmacokinetics clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. Approved for helicobacter pylori infection, pneumonia, bronchitis and 1 more indications. First approved in 1993.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BIAXIN (clarithromycin) is a macrolide antibiotic that inhibits bacterial protein synthesis, approved in 1993 for oral treatment of respiratory infections, H. pylori-associated ulcers, and Mycobacterium avium complex (MAC) in immunocompromised patients. It is rapidly absorbed from the gastrointestinal tract with peak plasma concentrations achieved within 2-3 hours, and forms an active metabolite (14-OH clarithromycin) that extends its antimicrobial effect.
LOE Approaching
BIAXIN faces imminent loss of exclusivity with no patent protection remaining, signaling reduced commercial investment and smaller brand team structure.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Clarithromycin is rapidly absorbed from the gastrointestinal tract after oral administration. The absolute bioavailability of 250 mg clarithromycin tablets was approximately 50%. For a single 500 mg dose of clarithromycin, food slightly delays the onset of…
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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.