NDAORALTABLET, EXTENDED RELEASE
Approved
Sep 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
AUGMENTIN XR (amoxicillin and clavulanate potassium) by Pfizer is 12. Approved for infections due to s, equal to 40 kg, acute bacterial sinusitis due to confirmed and 10 more indications. First approved in 2002.
Drug data last refreshed 13h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
AUGMENTIN XR is an extended-release oral antibiotic combining amoxicillin and clavulanate potassium, designed to treat bacterial infections caused by beta-lactamase-producing pathogens. The clavulanate component inhibits bacterial beta-lactamase enzymes, protecting amoxicillin from degradation and broadening its spectrum of activity. It is indicated for acute bacterial sinusitis and other infections in patients weighing ≥40 kg.
LOE Approaching
As a product approaching loss of exclusivity, AUGMENTIN XR faces significant generic pressure; commercial teams are likely focused on protecting share and managing transition strategies rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action Amoxicillin and Clavulanate Potassium Extended Release Tablets is an antibacterial drug [see Clinical Pharmacology ] . 12.3 Pharmacokinetics Amoxicillin and Clavulanate Potassium Extended Release Tablets is an extended-release formulation which provides sustained plasma…
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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.